2020 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| BD BACTEC™ Platelet Aerobic/F Culture Vials BD BACTEC™ Platelet Anaerobic/F Culture Vials Microbial growth monitor |
BD BACTEC™ Platelet Aerobic/F Culture Vials are used with the BD BACTEC™ FX instrument series for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Aerobic/F Culture Vials support the growth of aerobic microorganisms (bacteria and fungi). BD BACTEC™ Platelet Anaerobic/F Culture Vials are used with the BD BACTEC™ FX instrument series for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Anaerobic/F Culture Vials support the growth of anaerobic microorganisms. |
BK200530/0 | Becton, Dickinson & Company 7 Loveton Circle Sparks, MD 21152 |
12/23/2020 |
| SoftBank Version 25.6.1.0 (SoftBank.web) Blood establishment computer software and accessories |
The SoftBank software application supports single and multi-site transfusion services in healthcare facilities. The software application is intended to be used by knowledgeable, trained medical and healthcare personnel to document, query, and view the integrated information regarding patients and products. All steps and events are captured in this decision support system, including quality control testing, complete test and transfusion history, transfusion management, inventory management, product distribution and final disposition. The system allows manual data entry and retrieval, as well as automated data exchange by interfacing to hospital information systems, blood bank instruments, transfusion management systems and blood storage devices. | BK200531/0 | SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 |
12/18/2020 |
| ADAM-rWBC HT System Automated differential cell counter |
The ADAM-rWBC HT system is intended for in vitro use for the enumeration of residual white blood cells (rWBCs) in leukoreduced blood products. | BK200525/0 | NanoEntek, Inc. 17B Crestview Drive Westerly, RI 02891 |
12/01/2020 |
| LIAISON® XL MUREX HIV Ab/Ag HT LIAISON® XL MUREX Control HIV Ab/Ag HT HIV Detection Test |
The LIAISON® XL MUREX HIV Ab/Ag HT is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2–21 years) and in pregnant women. The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies. The LIAISON® XL MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL HIV Ab/Ag HT assay. |
BP190437/0 | DiaSorin, Inc. 1951 Northwestern Avenue Stillwater, MN 55082-0285 |
11/25/2020 |
| Maximus Processing System Blood PRP Kit Platelet and Plasma Separator for Bone Graft Handling |
To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. | BK200519/0 | Holding Technologies, Inc. 600 Royal Commerce Road Suite A Royal Palm Beach, FL 33411 |
11/19/2020 |
| DiaSpect™ system Automated hemoglobin system |
The DiaSpect™ system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2-EDTA or lithium heparin tubes in point-of-care settings and in non-anticoagulated capillary whole blood and venous whole blood drawn in K2-EDTA tubes in blood bank settings. The DiaSpect™ system consists of the DiaSpect™ analyzer and specifically designed disposable cuvettes. The DiaSpect™ analyzer is only to be used with DiaSpect™ Cuvettes. Rx only. |
BK200520/0 | EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben, Germany 39179 |
11/19/2020 |
| National Donor Deferral Registry (NDDR) and Cross Donation Check System (CDCS) Blood Establishment Computer Software and Accessories |
NDDR and CDCS is a responsive web based software application that is intended to:
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BK200526/0 | Headspring Healthcare, Inc. 10415 Morado Circle, Suite 300 Austin, TX 78759 |
11/18/2020 |
| e-Delphyn LIS Donor version 11.0.0.1 Blood establishment computer software and accessories |
e-Delphyn LIS Donor is a web enabled modular computerized system intended to be used by trained personnel to enter and evaluate test results in accordance with the decision rules as well as to manage sample storage and bacterial testing. | BK200513/0 | Hemasoft Software S.L. Speed to Market, Inc. P.O. Box 3018 Nederland, CO 80466 |
11/09/2020 |
| GDS (Grifols Donation System) V2.0 Blood establishment computer software and accessories |
GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor eligibility, unit suitability, shipments (units and samples), and sample management. GDS software provides management controls and information services modules that have been designed to assist personnel in the operational core functions in the company’s plasma donor centers. | BK200517/0 | Biomat USA, Inc. 2410 Lillyvale Avenue Los Angeles, CA 90032 |
11/05/2020 |
| e-Delphyn Donor version 11.0.0.1 Blood establishment computer software and accessories |
e-Delphyn Donor is a web enabled modular computerized system intended to be used by trained personnel to aid in donor management. The functionalities include:
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BK200515/0 | Hemasoft Software S.L. Speed to Market, Inc. P.O. Box 3018 Nederland, CO 80466 |
11/05/2020 |
| VioOneTM HIV ProfileTM Supplemental Assay HIV Detection Test |
An enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma. It is intended as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens repeatedly reactive in diagnosis or screening procedures, including pediatric patients (ages 2-20). | BP180279/0 | Avioq, Inc. 104 T.W. Alexander Drive, Bldg 6 Research Triangle Park, NC 27709 |
10/19/2020 |
| PK CMV-PA System Test, Donor, CMV |
The PK CMV-PA System is a passive particle agglutination assay intended for the qualitative detection of IgG and IgM antibodies to cytomegalovirus (CMV) in human EDTA plasma and serum from blood donors using the Beckman Coulter PK7300 and/or PK7400 Automated Microplate Systems. This test is not intended for diagnostic use. | BK200476/0 | Fujirebio Diagnostics, Inc 201 Great Valley Parkway Malvern, PA 19355 |
10/19/2020 |
| Regulated Software Application (RSA), Version 2.0 Blood Establishment Computer Software and Accessories |
The RSA system is a computerized system intended to be used by trained personnel to aid in and document the donation, manufacture and distribution of blood products. The system is intended to be “paperless”, i.e. it supports self-administered health history and complete documentation of the determination of eligibility, physical exam and phlebotomy of blood donors, and aids in the manufacture, labeling and shipment of blood and blood products. Each module communicates with a single database and interface with third party systems through standard network connections. The system is compatible with wired or wireless networks. | BK200512/0 | Arc-One Solutions, LLC 7901 Riviera Boulevard Miramar, FL 33023 |
10/15/2020 |
| Galileo NEO System, Test, Automated Blood Grouping and Antibody |
The Galileo NEO is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo NEO automates test processing, result interpretation and data management functions. The Galileo NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping and antigen screening. The Galileo NEO is for in vitro diagnostic use. |
BK200502/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
10/13/2020 |
| NexSys PCS® Plasma Collection System with Persona™ Technology Automated Blood Cell Separators |
The NexSys PCS® Plasma Collection System with Persona™ Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion. |
BK200498/0 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
10/02/2020 |
| DPP® HIV-Syphilis System HIV Detection Test |
A single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. | BP180191/0 | Chembio Diagnostic Systems, Inc. 3661 Horseblock Road, Medford, NY 11763 |
10/01/2020 |
| Amplifine Gel Separator Tube Platelet and Plasma Separator For Bone Graft Handling |
The Amplifine Gel Separator is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK200477/0 | Suneva Medical, Inc. 5870 Pacific Center Blvd San Diego, CA |
09/30/2020 |
| ASI Automated RPR test for Syphilis for use on the ASI Evolution Treponema pallidum nontreponemal test reagents |
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis for use on the ASI Evolution, is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis. The ASI Evolution is intended to be used as a fully automated analyzer to objectively interpret the results of the ASI Automated RPR Test for Syphilis. The ASI Evolution is designed to provide standardized test interpretation and to provide for storage, retrieval, and transmittal of the test results. The ASI Automated RPR Test for Syphilis for use on the ASI Evolution is for professional use only. The test is intended to be used for blood donor screening. The test is not intended for diagnostic use. |
BK200488/0 | Arlington Scientific, Inc. 1840 North Technology Drive Springville, UT 84663 |
09/30/2020 |
| cobas® HIV-1/HIV-2 Qualitative HIV Detection Test |
cobas® HIV-1/HIV-2 Qualitative for use on the cobas® 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma. The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. The cobas® HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women. |
BP190360/0 | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
08/12/2020 |
| Healeon Duet Platelet And Plasma Separator For Bone Graft Handling |
Healeon Duet is indicated to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK200449/0 | Haeleon Medical, Inc. ------------(b)(6)------------ ---------------------------------- |
08/06/2020 |
| iWeBB electronic Laboratory Information System (iWeBB-eLIS) Blood Establishment Computer Software and Accessories |
iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0, also referred to as eLIS, is software intended for use by trained blood banking laboratory personnel for managing patient information, blood transfusion requirements, blood specimen test orders, laboratory test results, blood product orders (including safety/compatibility checks for attributes, antibodies, and antigens), and patient transfusion histories. eLIS also interfaces to popular blood testing laboratory equipment and provides system reporting, printing, and data exporting features. | BK200491/0 | Carter BloodCare 2205 Highway 121 Bedford, TX 76021 |
07/29/2020 |
| The Arthrex Double Syringe (ACP) Kit Platelet And Plasma Separator For Bone Graft Handling |
The Double Syringe Autologous Conditioned Plasma (ACP®) System and Arthrex ACP Kits are indicated for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK200442/0 | Arthrex, Inc. 1370 Creekside Blvd Naples, Fl 34108 |
07/09/2020 |
| Alinity m HIV-1 HIV Detection Test |
The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System in human plasma from HIV-1 infected individuals. The Alinity m HIV-1 assay is intended for use in the clinical management of HIV-1 infected individuals in conjunction with clinical presentation and other laboratory markers. The Alinity m HIV-1 assay may be used to monitor disease prognosis by measuring the baseline plasma HIV-1 RNA level and to assess response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels. |
BP200455/0 | Abbott Molecular, Inc. 1300 East Touhy Avenue Des Plaines, IL 60018 |
07/02/2020 |
| Echo Lumena Galileo Echo (v 2.0) System, Test, Automated Blood Grouping and Antibody |
The Echo Lumena™ is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena™ automates test processing, result interpretation, and data management functions. The Echo Lumena™ is designed to automate standard immunohematology assays using a microwell strip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. The Echo Lumena™ is a closed system intended for use only with the reagents described in the Echo Lumena Operator Manual, Regional Attachment – North America- Echo Lumena Assay Reagents and Cutoffs. |
BK200483/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
06/22/2020 |
| PrepaCyte®-CB Processing System PCB 2100-270 Cord blood processing system and storage container |
The PrepaCyte-CB Cord Blood Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood prior to banking. | BK190356/0 | Cryo-Cell International, Inc. 700 Brooker Creek Blvd., Suite 1800 Oldsmar, FL 34677 |
06/17/2020 |
| NEO Iris Automated Blood Grouping and Antibody Test System |
The NEO Iris is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. The NEO Iris is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping and antigen screening. The NEO Iris is for in vitro diagnostic use. |
BK200474/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30091 |
06/12/2020 |
| WellSky™ Blood – Emergency Issue 2020 R1 Blood Establishment Computer Software and Accessories |
WellSky™ Blood – Emergency Issue 2020 R1 is intended to support the performance of HCLL™ Transfusion by enabling that device to perform according to its intended use by addressing all phases of transfusion services activities, and assist transfusion service personnel they relate to the emergency issue of blood products:
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BK200479/0 | WellSky Corporation 1300 Switzer Road Overland Park, KS 66210 |
06/12/2020 |
| ALYX Component Collection System Automated Blood Cell Separator |
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components. Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection system has been cleared for:
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BK200475/0 | Fenwal, Inc Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 |
06/10/2020 |
| Blood Product Administration Module Version 3-2020 Blood Establishment Computer Software and Accessories |
The Blood Product Administration Module is a software module intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion. The Module is based on a modular design allowing it to be used with a host electronic health record system. The Module can, through use of barcode technology, assist healthcare professionals in verifying patient identity at the bedside. The Module receives and manages blood product and order information from a host system and a blood bank system. The Module incorporates system-controlled logic that can require a positive match of the patient, the blood product to be administered, and information from the blood bank system. The Module can also check a blood product's documented expiration date for appropriateness. Blood administration information entered in the Module is transmitted to the host system for storage. |
BK200482/0 | Epic Systems Corporation Manatt, Phelps & Phillips, LLP One Embarcadero Center, 30th Floor San Francisco, CA 94111 |
06/10/2020 |
| Aeon CPKit Platelet and Plasma Separator for Bone Graft Handling |
The Aeon CPKit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. | BK190393/0 | Aeon Biotherapeutics Corp. 12F., No. 58 Ruihu St. Neihu Dist Taipei City, 11494, Taiwan (ROC) |
06/05/2020 |
| BACT/ALERT® BPA Culture Bottle BACT/ALERT® BPN Culture Bottle Microbial Growth Monitor |
BPA Culture Bottle BACT/ALERT® BPA culture bottles are used with BACT/ALERT® Microbial Detection Systems (BACT/ALERT® 3D and BACT/ALERT® VIRTUO®) for quality control testing of leukocyte-reduced apheresis platelet (LRAP) units, and both single and pools of up to six (6) units of leukocyte-reduced whole blood platelet concentrates (LRWBPC). BACT/ALERT® BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi). BPN Culture Bottle BACT/ALERT® BPN culture bottles are used with the BACT/ALERT® Microbial Detection Systems (BACT/ALERT® 3D and BACT/ALERT® VIRTUO®) for quality control testing of leukocyte-reduced apheresis platelet (LRAP) units, and both single and pools of up to six (6) units of leukocyte-reduced whole blood platelet concentrates (LRWBPC). BACT/ALERT® BPN culture bottles support the growth of anaerobic and facultative anaerobic microorganisms (bacteria). BACT/ALERT® Microbial Detection Systems are used to detect bacteria in platelet components. BACT/ALERT® Microbial Detection Systems are used as a safety measure, to extend dating beyond day 5 and up to day 7 for the following (Ref. FDA guidance):
BACT/ALERT® Microbial Detection Systems are used to extend dating to five days for the following (Ref. FDA guidance):
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BK200472/0 | bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
05/20/2020 |
| PK7400 Automated Microplate System Automated Blood Grouping and Antibody Test Systems |
The Beckman Coulter PK7400 Automated Microplate System is a high throughput, fully automated, batch test system that uses agglutination technology with Beckman Coulter terraced microplates. The PK7400 performs donor ABO blood grouping, Rh typing, including weak D testing, red blood cell antigen screening using Diagast reagents. The PK7400 is also intended for use with specific qualitative infectious disease assays that are cleared or approved and are labeled indicating their use on this system for blood donor screening. This system is for in vitro diagnostic use only. | BK180292/0 | Beckman Coulter, Inc. 250 South Kraemer Boulevard Brea, California 92821 |
05/07/2020 |
| PK SYSTEM CONTROL Quality Control Kits for Blood Banking Reagents |
The PK SYSTEM BLOOD GROUPING REAGENTS and PK SYSTEM CONTROL are intended for the determination of ABO blood group, Rh and Kell phenotypes in blood donors using the BECKMAN COULTER PK7300 and/or the BECKMAN COULTER PK7400 Automated Microplate System(s). The Anti-A, Anti-B, and Anti-A,B reagents are used in the red blood cell determination of the ABO blood group.They are used to determine the absence or presence of erythrocytic antigens A and/or B on the surface of human red blood cells. The Anti-D reagents: Anti-D, Anti-D (PK 1), Anti-D (PK 2), are used to determine the Rh(D) type. They are used to detect the presence of the Rh(D) antigen on the surface of human red blood cells. The Anti-C, Anti-E, Anti-c, Anti-e, and Anti-K are used for Rh Subgroups and Kell phenotyping of human red blood cells. These reagents detect the presence of antigens C, E, c, e, and K on the surface of red blood cells. The CONTROL is devoid of antibody activity and should be used in parallel testing with the PK SYSTEM BLOOD GROUPING REAGENTS to differentiate between specific and non-specific agglutination. |
BK190313/0 | DIAGAST NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
05/07/2020 |
| Aurora Xi Plasmapheresis System Aurora Xi System Aurora Xi, Software Version 1.2 Automated Blood Cell Separators |
The Aurora Xi Plasmapheresis system is intended for the automated collection of plasma by membrane filtration to be processed as Source Plasma. The Aurora Xi system is to be used with a single-use PLASMACELL Xi disposable set and 4% sodium citrate anticoagulant, and allows for Saline and No Saline Protocol options. | BK200478/0 | Fresenius Kabi AG Fresenius Kabi USA Three Corporate Drive Lake Zurich, IL 60047 |
05/07/2020 |
| Erytra Eflexis Automated Blood Grouping and Antibody Test Systems |
Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. |
BK200467/0 | Grifols Diagnostics, S.A. Passeig Fluvial, 24 Parets del Valles Barcelona, 08150 Spain |
04/23/2020 |
| GeTrap Blood Establishment Computer Software and Accessories |
GeTraP is a software application used to support daily operations of product logistics primarily organizing and controlling the information about the transport of plasma units between facilities such as warehouses and fractionators. GeTrap supports trained personnel in tracking data received from suppliers, verifying each plasma units’ suitability for further manufacture. | BK200456/0 | Kedrion S.p.A. Parker Plaza, 11th Floor 400 Kelby Street Fort Lee, NJ 07024 |
04/20/2020 |
| Elecsys HIV Duo HIV Detection Test |
Is an immunoassay intended for the in vitro simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2 in human serum and plasma. Intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than 2 years of age and in pregnant women. Elecsys HIV Duo is not intended for the screening of blood and plasma donors. Elecsys HIV is an electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e 801 immunoassay analyzer. | BP190403/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0416 |
04/10/2020 |
| RD2 System Peripheral Blood Processing Device for Wound Management |
The RD2 System is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC gel produced by the RD2 System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds. | BK200464/0 | RedDress, Ltd. Hogan Lovells 1735 Market Street, 23rd Floor Philadelphia, PA 19104 |
03/20/2020 |
| AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System (A123+ AuraClens) Lipoaspirate washing system for aesthetic body contouring |
The A123+AuraClens is to be used to filter and wash aspirated, harvested autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. The A123+AuraClens may be used in processing harvested adipose tissue obtained in surgical specialties, including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. The A123+ AuraClens is not intended to process autologous adipose tissue other than for aesthetic body contouring uses. |
BK190433/0 | AuraGen Aesthetics LLC Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
03/13/2020 |
| Anti-D Donor Management and Inventory System (ADIMS) Version 1.7 Blood Establishment Computer Software and Accessories |
ADIMS is indicated for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells by performing the following tasks:
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BK190430/0 | CSL Plasma 900 Broken Sound Parkway NW #400 Boca Raton, FL 33487 |
03/11/2020 |
| Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports 4R2088P Empty Containers for the Collection & Processing of Blood/Blood Components |
For processing and/or storage of blood and blood components | BK190421/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 |
03/11/2020 |
| ORTHO CONNECT™ 3.0 Automated Blood Grouping and Antibody Test Systems |
ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation. |
BK190434/0 | STRATEC Biomedical UK Limited STRATEC BIOMEDICAL USA, INC. 1 Center Street, Suite 2B Southington, CT 06489 |
03/9/2020 |
| PurePRP® SupraPhysiologic Concentrating System Platelet and Plasma Separator for Bone Graft Handling |
The PurePRP® SupraPhysiologic Concentrating System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP is mixed with autograft and allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics. | BK190317/0 | EmCyte Corporation 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 |
02/12/2020 |
| CompoMaster Net G5 Plus 9026551 CompoMat G5 Plus 9026561 Blood Bank Supplies |
The CompoMat G5 Plus / CompoMaster Net G5 Plus System is intended as an automated blood component separator used for blood component separation and preparation. | BK190413/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, Illinois 60047 |
02/06/2020 |
| HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version) Blood mixing devices and blood weighing devices |
HemoMix 4 device is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached. | BK190429/0 | Delcon S.R.L Via Zanica, 19 F/I 24050 Grassobbio (BG) Italy |
01/30/2020 |
| MATCH IT!® DNA (version 1.3) Qualitative Test for HLA, Non-diagnostic |
MATCH IT!® DNA Software is an accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES HLA SSO kits for use with Luminex. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to assure correctness. | BK190439/0 | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukeshaha, WI 53186 |
01/21/2020 |