2025 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 |
|---|---|---|---|---|
| cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems Human immunodeficiency virus (HIV) viral load monitoring test | cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals using the automated cobas® 5800/6800/8800 systems for specimen processing, amplification and detection. The test can quantitate HIV-1 RNA over the range of 20-10,000,000 cp/mL (33 to 1.67 x 107 International Units/mL). This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment. cobas® HIV-1 is not intended for use as a screening test for the presence of HIV-1 in donated blood or plasma or as a diagnostic test to confirm the presence of HIV-1 infection. | BK251235/0 | 4300 Hacienda Drive Pleasanton, CA 94588 | 07/01/2025 |
| cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the 5800/6800/8800 systems Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test | cobas® HIV-1/HIV-2 Qualitative for use on the cobas® 5800/6800/8800 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. This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV. | BK251233/0 | Roche Molecular Systems, Inc 4300 Hacienda Drive | 06/27/2025 |
| Erytra Eflexis 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, Antibody Titration, 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. | BK251182/0 | Diagnostic Grifols, S.A. Passeig Fluvial, 24 | 06/17/2025 |
| Erytra Automated blood grouping and antibody test system | The Erytra is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), the Erytra automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. | BK251183/0 | Diagnostic Grifols, S.A. Passeig Fluvial, 24 | 06/17/2025 |
| DG Gel 8 Neutral card Automated blood grouping and antibody test system | The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use. | BK251184/0 | Diagnostic Grifols, S.A. Passeig Fluvial, 24 | 06/17/2025 |
| Patient Health Software (P.H.S) v11.0.0.0 Blood establishment computer software and accessories | The eTraceLine / Patient Health Software (P.H.S) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. eTraceLine/P.H.S is designed to aid and assist qualified and trained personnel to support the operations within their facilities. eTraceLine/P.H.S software supports single, centralized multi-sites and multi-organizations to be used centrally or in standalone. eTraceLine/P.H.S undertakes process controls for laboratory testing and transfusion service operations, manages, tracks and determines the suitability of the blood components and blood derivatives to reduce human error and contribute to patient safety. eTraceLine/P.H.S intended to address all phases of laboratory activities and/or transfusion services operations at the laboratory department, transfusion service departments, hospital wards, and patient bedside. Functionality is provided for:
eTraceLine/P.H.S interfaces with Hospital Information Systems (HIS), laboratory testing instruments, BECS, Laboratory Information Systems (LIS), and blood storage devices. | BK251188/0 | MAK-SYSTEM Group Ltd. 1 Bartholomew Lane | 06/11/2025 |
| LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test | The LIAISON® MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum (without or with gel-SST) or plasma (lithium and sodium heparin, sodium citrate, and potassium EDTA), on the LIAISON® XL Analyzer or LIAISON® XS Analyzer. It 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® MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX HIV Ab/Ag HT assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL and LIAISON® XS. | BK241116/0 | DiaSorin, Inc. 1951 Northwestern Avenue | 06/10/2025 |
| SkinDisc™ SkinDisc™ Lite Peripheral blood processing device for wound management | The SkinDisc™ Wound System is designed to be used at point-of-care for the safe and rapid preparation of platelet rich plasma (PRP) and platelet poor plasma (PPP), from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the SkinDisc™ is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds. | BK241079/0 | Innoveren Scientific, Inc. 151 W. 4th St., Ste. 226. Cincinnati, OH 45202 | 03/28/2025 |
| Giotto Monza (BCS03) Blood bank supplies | The Giotto Monza is intended as an automated blood component separator used for blood components separation and preparation. | BK231039/0 | Delcon S.r.l. Via Zanica 19F 24050 Grassobbio Italy | 03/26/2025 |
| Adaptive Nomogram Bottle Empty container for the collection and processing of blood and blood components | For the collection, storage, and shipment of plasma prior to fractionation. | BK251160/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 | 02/21/2025 |
| Lookback Notification System version 2.0 Blood establishment computer software and accessories | The Lookback Notification System is intended to generate and maintain electronic lookback records and allows for the automated creation, distribution and updating of applicable consignee notifications to assist in effectively identifying and removing unsuitable units (Source Plasma), prior to manufacturing. | BK241136/0 | BioLife Plasma Services LP 1200 Lakeside Drive Bannockburn, IL 60015 | 02/20/2025 |
| Aurora Xi Plasmapheresis System Software Version 2.0 Automated Blood Cell Separator | 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. | BK241135/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 | 01/24/2025 |
| cobas pro serology solution (applicable to) a) Elecsys Syphilis b) Elecsys Anti-CMV Test, Syphilis, Treponema (FOR DONOR TESTING) | Syphilis Assay: 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. Anti-CMV Assay: 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 with cobas pro serology solution equipped with the cobas e 801 analytical unit. cobas pro serology solution: The cobas pro serology solution is a combination of the cobas pro serology controller, cobas pro integrated solutions (cobas e 801 analytical units only) and applicable licensed blood screening assays. The system automates electrochemiluminescence immunoassay test processing, result interpretation, and data management functions for screening of donations of whole blood and blood components using plasma or serum samples. The system is intended for use only with licensed blood screening assays in US donor screening laboratories and plasma fractionators. It is intended for use only by personnel who are trained in its operation. The cobas pro serology solution is intended to be used by trained laboratory technicians. Intended customers Intended customers of the cobas pro serology controller used in combination with cobas pro integrated solutions (cobas e 801 analytical units only) are donor screening and plasma fractionation companies in the United States. | BK241148/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 | 01/10/2025 |
| AHC Platelet Concentrate Separator Platelet and Plasma Separator for Bone Graft Handling | The AHC Platelet Concentrate Separator is designed to be used for preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK231018/0 | Sunphoria Co.,Ltd 12F-1, No. 51, Hengyang Rd, Zhongzheng Dist. Taipei City, 10045 Taiwan | 01/10/2025 |
| Galileo Echo Automated blood grouping and antibody test system | The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a micro-well 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 Galileo Echo is a closed system intended for use only with the reagents described in the Galileo Echo Operator Manual, Regional Attachment - North America - Galileo Echo Assay Reagents and Cutoffs. The Galileo Echo is for in vitro diagnostic use. | BK210608/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 | 01/08/2025 |
| Complement Control Cells Quality control kit for blood banking reagents | Complement Control Cells are intended for use in confirming reactivity of the anti-C3 component of Anti-Human Globulin. | BK210604/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 | 01/08/2025 |
| Echo Lumena Automated blood grouping and antibody test system | 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. The Echo Lumena is for in vitro diagnostic use. | BK210601/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 | 01/08/2025 |
| MatchX Test, Qualitative, for HLA, Non-Diagnostic | MatchX is an optional accessory to the following LIFECODES antibody detection kits and LIFECODES HLA-SSO Typing Kit for use with Luminex: LIFECODES LifeScreen Deluxe 628215 LIFECODES LifeScreen XP 628220 LIFECODES Class I ID 628200 LIFECODES Class II ID v2 628223 LIFECODES LSA Class I 265100IVD LIFECODES LSA Class II 265200IVD LIFECODES HLA-A eRES SSO Typing Kit 628913 LIFECODES HLA-B eRES SSO Typing Kit 628917 LIFECODES HLA-C eRES SSO Typing Kit 628921 LIFECODES HLA-DRB1 eRES SSO Typing Kit 628925 LIFECODES HLA-DRB 345 SSO Typing Kit 628927 LIFECODES HLA-DQA1/B1 SSO Typing Kit 628930 LIFECODES HLA-DPA1/B1 SSO Typing Kit 628936 Default settings for all assays are aligned with the IFU and the performance characteristics of the assay. Any other methods of assignment would need to be validated by lab personal prior to use. The software is intended for In Vitro Diagnostic (IVD) use. | BK241067/0 | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 | 01/02/2025 |