2023 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.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| Reveal® G4 Rapid HIV-1/2 Antibody Test Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test |
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms. | BK231015/0 | MedMira Laboratories, Inc. 155 Chain Lake Drive, Suite 1 Halifax, NS B3S 1B3, Canada |
12/13/2023 |
| Blood Product Questionnaire Module Blood establishment computer software and accessories |
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members. | BK231004/0 | Buoy Software, LLC 55 Post Road West, 2nd Floor Westport, CT 06880 |
11/16/2023 |
| ePROGESA v5.0.3 Blood establishment computer software and accessories |
ePROGESA is a modular, stand-alone blood bank, plasma centers, and blood transfusion service software application that is specially designed to meet the needs of organizations collecting blood, plasma, platelets, cord blood, and/or transfusion services organizations to aid/assist qualified and trained personnel to support the major operations within their facilities. ePROGESA is designed to undertake typical blood bank operations on fixed and mobile sites including but not limited to session planning and recruitment of donors; donor eligibility status including deferrals management, interactive donor health questionnaire (Computer Assisted Self Interviews (CASI)), also called SAHH feature, completed by staff or donors or remote donors and reviewed by a blood center-trained staff; immunization traceability for plasma donors; donation collection; component preparation and transformation; donor and donation laboratory testing; blood unit stage release; blood inventory, and distribution of blood products and manufactured products, product quality control including bacterial screening; blood products lookback and donor surveillance; HLA/RBC searching and matching. ePROGESA is also intended to support typical blood transfusion operations of order management, patient management, inventory selection, testing, further manufacturing, release, and distribution of blood products and manufactured products, track product disposition and keep transfusion history. Orders and reporting of patient results can be managed by interface with the Hospital Information System. ePROGESA also includes interfaces for the National Deferred Donor Register (NDDR), collection and manufacturing devices, LIMS, quality control and Laboratory Instruments which assist trained personnel in the transfer and integration of data to the ePROGESA software. |
BK230986/0 | MAK-SYSTEM Group Ltd. 1 Bartholomew Lane London United Kingdom |
11/03/2023 |
| Elecsys Anti-CMV PreciControl Anti-CMV PreciControl Release Anti-CMV Cytomegalovirus serological reagents |
Elecsys Anti-CMV Elecsys Anti-CMV is an in vitro immunoassay for the qualitative detection of antibodies to Cytomegalovirus in human serum and plasma. Elecsys Anti-CMV is intended to screen individual human donors, including volunteer donors of whole blood, and blood components. This test is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with the cobas e 801 analytical unit. PreciControl Anti-CMV PreciControl Anti-CMV is used for quality control of the Elecsys Anti-CMV immunoassay on cobas pro serology solution. PreciControl Release Anti-CMV PreciControl Release Anti-CMV is used to validate the cobas pro serology solution and to release sample results for the Elecsys Anti-CMV immunoassay. The recovery of the release control within Roche specified limits ensures the specified sensitivity of the assay under customer site conditions. The release control is tested at user-defined intervals with a maximum span of every 300 samples or 350 determinations and must be tested in order to release the test results. For release control values that fall outside the defined limits, samples measured before a failed release control are flagged as invalid by the cobas pro serology controller and need to be repeated. Reactive results will not be invalidated by a failed release control and must be retested in duplicate. |
BK230840/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
11/03/2023 |
| AQUIOS CL Flow Cytometer and AQUIOS Stem Kit Flow Cytometric Reagents and Accessories |
AQUIOS CL Flow Cytometer The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels, and electronic volume (EV). AQUIOS Flow Cytometry Software may be run on an independent computer workstation for offline analysis of results generated by the AQUIOS CL Flow Cytometer with its monoclonal antibody reagents. The offline analysis must be performed in accordance with the product labeling. AQUIOS STEM Kit The AQUIOS STEM Kit is an in vitro diagnostic medical device intended to be used by laboratory professionals for the simultaneous identification and enumeration of percent (%) CD34+ cell population, CD34+ cells/ul, and CD45+ cells/ul in fresh peripheral or mobilized peripheral whole blood, fresh or thawed bone marrow, fresh or thawed apheresis products, and fresh or thawed cord blood on the automated AQUIOS CL Flow Cytometry System. |
BK230961/0 | Beckman Coulter, Inc. 11800 SW 147th Avenue Miami, FL 33196 |
09/01/2023 |
| nSTRIDE® PRP Concentration System Platelet and Plasma Separator for Bone Graft Handling |
The nSTRIDE® PRP Concentration System with GPS® III Separator device with ACD-A is 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. |
BK230844/0 | Biomet Biologics, Inc. 56 E. Bell Drive Warsaw, IN 46582-6924 |
08/09/2023 |
| IH-500 Automated blood grouping and antibody test system |
The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, and provides reaction grading /interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control, direct antiglobulin testing and antibody titration testing. In the USA, IH-500 is “Rx only”. The IH-500 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-500 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. Use of IH-500 is only permitted with gel cards and reagents from the IH-System as authorized by Bio-Rad. The use of any material not specified in the U.S. User Manual (e.g. non-authorized substances) is forbidden. |
BK230971/0 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories Inc. 6565 185th Avenue NE Redmond, WA 98052 |
08/09/2023 |
| Elecsys Syphilis PreciControl Syphilis PreciControl Release Syphilis Treponema pallidum Treponemal Test reagents |
Elecsys Syphilis Elecsys Syphilis is an in vitro immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. Elecsys Syphilis is intended to screen individual human donors, including volunteer donors of whole blood and blood components. This test is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay“ECLIA” is intended for use with the cobas pro serology solution equipped with cobas e 801 analytical unit. PreciControl Syphilis PreciControl Syphilis is used for quality control of the Elecsys Syphilis immunoassay on cobas pro serology solution. PreciControl Release Syphilis PreciControl Release Syphilis is used to validate the cobas pro serology solution and to release sample results for the Elecsys Syphilis immunoassay. The recovery of the release control within Roche specified limits ensures the specified sensitivity of the assay under customer site conditions. The release control is tested at user-defined intervals with a maximum span of every 300 samples or 350 determinations and must be tested in order to release the test results. For release control values that fall outside the defined limits, samples measured before a failed release control are flagged as invalid by the cobas pro serology controller and need to be repeated. Reactive results will not be invalidated by a failed release control and must be retested in duplicate. |
BK230839/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 |
07/31/2023 |
| IMUGARD WB PLT Platelet Pooling Set Empty container for the collection and processing of blood and blood components |
IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool and store whole-blood-derived platelets. For platelets prepared through manual methods, leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. For platelets prepared by the Reveos® Automated Blood Processing System, leukoreduction and pooling occur on Day 1 or Day 2, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a "safety measure." | BK230838/0 | Terumo BCT 10811 West Collins Avenue Lakewood, CO 80215 |
07/27/2023 |
| Reveos® Automated Whole Blood Processing System Separator, Semi-Automated, Blood Component |
The Reveos device is intended to automatically separate units of whole blood into blood components. | BK230843/0 | Terumo BCT 10811 West Collins Avenue Lakewood, CO 80215 |
07/27/2023 |
| Access HIV Ag/Ab combo Access HIV Ag/Ab combo Calibrators Access HIV Ag/Ab combo QC Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test |
The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vitro detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human pediatric (ages 2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid-citrate-dextrose (ACD) and citrate phosphate-dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access HIV Ag/Ab combo assay is 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 and/or HIV-2 infection in pregnant women. The Access HIV Ag/Ab combo assay is for use on the DxI 9000 Access Immunoassay Analyzer only. This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps). The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human serum and plasma, using the DxI 9000 Access Immunoassay Analyzer. The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV Ag/Ab combo QC is for use on the DxI 9000 Access Immunoassay Analyzer. |
BK230833/0 | Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 |
07/27/2023 |
| BD Leucocount™ Kit, BD FACSuite™ Clinical BD Leucocount™ BD FACSLyric™ Flow Cytometer Flow Cytometric Reagents and Accessories |
BD Leucocount™ Kit The BD Leucocount™ Kit consists of BD Leucocount™ Reagent (propidium iodide fluorescent dye) and BD Trucount™ Tubes and is intended for use with the BD FACSCalibur™, BD FACSort™, BD FACScan™, BD FACSVia™, and BD FACSLyric™ flow cytometer systems, or for a flow cytometer equipped with a 488-nm laser able to threshold on propidium iodide fluorescence, for enumerating residual white blood cells (rWBCs) in leucoreduced blood products. For in vitro diagnostic use. ------------------------------ BD FACSLyric™ Flow Cytometer The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for the following:
It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. |
BK230835/0 | Becton, Dickinson & Company 2350 Qume Drive San Jose, CA 95131 |
07/24/2023 |
| Blood Typing Manager, version 3.0 Blood establishment computer software and accessories |
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and aids users in Antibody Identification procedure. Blood Typing Manager includes the following features:
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BK230811/0 | Diagnostic Grifols, S. A. Passeig Fluvial, 24 Parets del Valles, Barcelona 08150 Spain |
07/24/2023 |
| WellSky® Transfusion 2022 R3 Blood Establishment Computer Software and Accessories |
WellSky® Transfusion 2022 R3 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
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BK230826/0 | WellSky Corporation 11300 Switzer Road Overland Park, KS 66210 |
07/19/2023 |
| e-Delphyn Donor 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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BK220791/0 | GPI USA, Inc. 4900 Woodway Drive, Suite 680 Houston, TX 77056 |
06/26/2023 |
| Erytra Eflexis 3.0.0 Automated Blood Grouping and Antibody Test System |
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. |
BK230820/0 | Diagnostic Grifols, S.A. Passeig Fluvial, 24 Parets del Valles Barcelona, Spain 08150 |
06/22/2023 |
| NexSys PCS® Plasma Collection System with Express®Plus Technology Automated blood cell separator |
The NexSys PCS® plasma collection system with Express®Plus 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. Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only. |
BK220798/0 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 |
06/20/2023 |
| RECELL Autologous Cell Harvesting Device (Model Number: AVRL0102) Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator |
This device is indicated for repigmentation of stable depigmented vitiligo lesions in patients 18 years of age and older. The RECELL Device is intended for use by an appropriately licensed and trained healthcare professional at the patient’s point-of-care for the safe and rapid preparation of Spray-On Skin Cells from a small sample of a patient’s own skin. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site. | BP220799/0 | AVITA Medical LLC 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 |
06/16/2023 |
| VorFat System Lipoaspirate Washing System For Aesthetic Body Contouring |
The VorFat System is intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue for aesthetic body contouring is desired:
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BK220668/0 | Alma Lasers, Inc. 485 Half Day Rd, Suite 100 Buffalo Grove, IL 60089 |
06/12/2023 |
| Dr. PRP Platelet and Plasma Separator for Bone Graft Handling |
The Dr.PRP 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. | BK230818/0 | YTS Global Inc. 7406 Alban Station Ct Suite A108 Springfield, VA 22150 |
05/31/2023 |
| Capture Positive Control Cell Quality control kit for blood banking reagents |
ImmuLINK is software intended for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. ImmuLINK includes the following features and/or functions: Capture Positive Control Cell is used as an antiglobulin control, and to monitor washing efficacy and reactivity of the Capture-R Ready Indicator Red Cells (CRRIRC). | BK220779/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
05/10/2023 |
| Adaptive Autologous Processing System Platelet and Plasma Separator for Bone Graft Handling |
The Adaptive Autologous Processing System™ (AAPS) 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 point‐of‐care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK230807/0 | Genesis Biologics, Inc. -(b)(6)--------------------- -------------------- |
05/10/2023 |
| ImmuLINK (v3.0) Blood establishment computer software and accessories |
ImmuLINK is software intended for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. ImmuLINK includes the following features and/or functions:
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BK230806/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
04/25/2023 |
| AMICUS Separator System Automated blood cell separator |
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. | BK230824/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 |
04/21/2023 |
| Elecsys HIV Duo Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test |
Elecsys HIV Duo 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. Elecsys HIV Duo assay is 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 donors of blood and blood components or human cells, tissues, and cellular and tissue-based products (HCT/Ps). Elecsys HIV Duo is an electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e 402 and cobas e 801 immunoassay analyzers. |
BK230804/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 |
04/04/2023 |
| Blood Bank Control System V6.0 Blood Establishment Computer Software and Accessories |
Blood Bank Control System V6.0 is intended to be used by trained personnel to aid in the collection, manufacture and distribution of blood and blood components. The software is designed to identify eligible donors by the use of both user and donor administered history questionnaire functionality (Computer Assisted Self Interviews (CASI)) along with additional system logic to determine donor eligibility which includes testing as well as donor health screening. The system prevents the release of unsuitable blood and blood components for transfusion or further manufacturing by performing compatibility testing and aids in the manufacture, labeling and shipment of blood and blood products. The system supports the determination of compatibility status of product per patient for transfusion service operations. | BK220790/0 | Blood Bank Computer Systems, Inc. 7206 Vandermark Rd. E Bonney Lake, WA 98391 |
02/17/2023 |
| Procedure Tray - Lipoaspirate fat harvest and injection kit Suction lipoplasty system |
LG PT 15, LG PT 14, LG PT 12, LG PT 04, LG PT 03, LG PT 02 are intended for removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring, within the same procedure. In combination with the Lipogems System these devices are intended for use in the following surgical specialties: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery. | BK220775/0 | Hydra Srl Coronati Consulting Srl Via Luigi Gavioli, 3 I-41037 Mirandola (MO) Italy |
01/04/2023 |