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  1. Development & Approval Process (CBER)

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.

2020 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
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.
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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:
  • Allow for emergency patient safety protocols.
  • Issue blood products under emergency conditions.
  • Confirmation scan of correct transfusion slip on correct unit.
  • Use of emergency issue products on a mobile device and desktop workstation.
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:
  • Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced
    • Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
  • Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced
    • Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
  • Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as
    • Fresh Frozen Plasma
      • Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
    • Source Plasma
    • Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
      • Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
    • Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
      • Can be stored at room temperature for up to 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
  • Collection of Plasma as
    • Fresh Frozen Plasma,
      • Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
    • Source Plasma
    • Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
      • Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
    • Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
      • Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
      • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
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):
  • Large volume delayed sampling (LVDS) of platelets no sooner than 48 hours after collection; OR
  • Secondary culture no sooner than day 4 after platelet collection.

BACT/ALERT® Microbial Detection Systems are used to extend dating to five days for the following (Ref. FDA guidance):
  • Large volume, delayed sampling of platelets no sooner than 36 hours after collection; OR
  • Secondary culture no sooner than day 3 after platelet collection.
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:
  • ADIMS is used to determine donor eligibility and release of the blood or blood component as suitable for transfusion;
  • ADIMS is used to track the preparation of immunogen components (vials) for storage and distribution;
  • ADIMS is used to track the recipient of transfused immunogen RBCs
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

 

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