2026 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 |
|---|---|---|---|---|
| Donor Information System Version 9.0 Blood establishment computer software and accessories | The Donor Information System (DIS) is used to manage donation center operations including but not limited to screening of donors for eligibility, immunizations, source plasma collection processing, and determining unit suitability.
| BK251307/0 | BioLife Plasma Services LP 1200 Lakeside Drive | 08/11/2026 |
| ADAMII CD34 System Automated differential cell counter | ADAMII CD34 System includes ADAMII-CD34 Kit which is designed for use with ADAMII (Instrument), a benchtop image-based fluorescence cell counter. ADAMII CD34 System provides enumeration of viable CD34+ cells, viable CD45+ cells, and calculates percentage of viable CD34+ cells out of viable CD45+ cells. ADAMII CD34 System can be used for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, fresh and thawed hematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin, fresh cord blood (FCB) collected in CPD, and thawed frozen cord blood (TFCB) collected in CPD and stored with 10% DMSO, 1% Dextran 40. ADAMII CD34 System is intended for use in clinical laboratories and for in vitro diagnostic use only. It is not intended for use in point-of-care settings. | BK261351/0 | NanoEntek, Inc 12f, 5, Digital-Ro 26-Gil Grro-Gu adam_fda@nanoentek.net | 07/20/2026 |
| HIV Combo Next Assay Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test | The HIV Combo Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the simultaneous qualitative detection of human immunodeficiency virus type 1 (HIV-1) p24 antigen and antibodies to HIV-1 group M and O and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin) on the Alinity i system. The HIV Combo Next assay is 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/HIV-2 infection in pediatric subjects (greater than or equal to two years of age) and in pregnant women. An HIV Combo Next reactive result does not distinguish between the detection of HIV-1 antigen, HIV-2 antigen, HIV-1 antibodies, and HIV-2 antibodies. 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. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable, or their use is impractical. | BK261345/0 | Abbott Laboratories. 100 Abbott Park Road | 06/29/2026 |
| SeCore CDx HLA Sequencing System Human leukocyte antigen typing companion diagnostic test | The SeCore CDx HLA Sequencing System is intended for the detection of human leukocyte antigen A-locus (HLA-A) alleles using genomic DNA isolated from whole blood samples. The device is intended to be used as a companion diagnostic (CDx) to aid in the selection of patients who may benefit from treatment or are likely to be at increased risk for serious adverse reactions because of treatment with therapies listed in the table below when used in accordance with approved therapeutic labeling: Proposed Indication(s) HLA Target Allele(s) Therapy Unresectable or Metastatic Uveal Melanoma Eligible allele: HLA-A*02:01 KIMMTRAK® (tebentafusp-tebn) Unresectable or Metastatic Synovial Sarcoma in Patients who have received prior chemotherapy TECELRA® (afamitresgene autoleucel) | BK261357/0 | One Lambda, Inc. 22801 Roscoe Boulevard | 06/17/2026 |
cobas® HIV-1/HIV-2 Qualitative for use on cobas®
| 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) nucleic acid 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. The test is also intended for early infant diagnosis (EID) of HIV-1 or HIV-2 infection in infants <= 18 months using dried blood spot (DBS) specimens. 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. | BK261349/0 | Roche Molecular Systems, Inc. 4300 Hacienda Drive | 06/17/2026 |
| MEDIFLY Maggots Maggots, Medical | MEDIFLY Maggots are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds. | BK251252/0 | Cuprina Pte. Ltd 1090 Lower Delta Road | 06/12/2026 |
| Blood Product Questionnaire Module v2.0.0 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, the determination of donor eligibility, and unit suitability as determined through system logic or via analysis by trained facility staff members. | BK261333/0 | Buoy Software, LLC 811 Barton Springs Road, Suite 510 | 06/08/2026 |
| RegenBMC® (RegenKit®-THT®-BMC) Automated blood cell separator | The RegenBMC® system is indicated to be used intraoperatively at the point-of-care for the safe and rapid preparation of autologous platelet concentrate platelet-rich plasma (PRP) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK251274/0 | Regen Lab, USA, LLC -------(b)(4)------- ----(b)(4)---- ----------(b)(4)-------- ----(b)(4)- -------(b)(4)------- | 05/29/2026 |
| ELUclear Elution Kit Blood bank supplies | The ELUclear Elution Kit removes antibodies bound to red cell antigens through a controlled dissociated process. When antibody coated red cell antigens are exposed to an acidic elution solution, protonation of the antigen-antibody complex occurs, disrupting the electrostatic bonds between antibody and antigen. This pH-induced charge repulsion effectively dissociates the antibodies from the antigens. Following elution, the pH is restored to optimal conditions for serological testing, allowing further investigation of the recovered antibodies. | BK261315/0 | Hemo Bioscience, Inc. 4022 Stirrup Creek Drive, Suite 311 | 05/29/2026 |
| LIAISON® MUREX HIV Ab/Ag HT LIAISON® XL LIAISON® diluteX Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test | LIAISON® Murex HIV Ab/Ag HT 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 HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV. LIAISON® XL The LIAISON® XL Analyzer is a Diagnostic System that measures chemiluminescence. It is intended strictly for professional in-vitro Diagnostic use. It is to be used only with Chemiluminescence Immunoassays authorized by DiaSorin Italia S.p.A. for the LIAISON® XL instrument. The analyzer can be connected to a third-party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays. LIAISON® diluteX The LIAISON® diluteX is an accessory for the LIAISON® XL analyzer. It is designed to automatically dilute the LIAISON® Wash/System Liquid with purified water and to distribute both the purified water and the diluted Wash/System Liquid (referred to as “Wash Buffer”) to each connected LIAISON® XL. The LIAISON® diluteX utilizes purified water (referred to as "sourced water"), which must be supplied to the device. The device automatically dilutes the concentrated Wash Buffer, stored on the device, with the sourced water and distributes both the diluted Wash/System Liquid and the sourced water to the LIAISON® XL via separate tubes directly into the analyzer’s tanks. For professional use only. | BK261335/0 | DiaSorin Inc. 1951 Northwestern Avenue | 05/29/2026 |
| 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. | BK261329/0 | Diagnostic Grifols, S.A. Passeig Fluvial, 24 08150 Parets del Vallès Spain | 05/21/2026 |
| ORTHO Optix™ Reader Automated blood grouping and antibody test system | The ORTHO Optix™ Reader is a system designed to automate reaction grading, results interpretation and data management when performing in vitro immunohematology testing of human blood utilizing ID-MTS™ Gel card technology. The ORTHO Optix™ Reader can be used as a standalone instrument or interfaced to the customer’s Laboratory Information System (LIS). | BK261331/0 | Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202 Raritan, NJ 08869 | 05/13/2026 |
| Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400) Suction lipoplasty system | The Viality™ Lipoaspirate Wash System 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 Viality™ system 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 Viality™ system is not intended to process autologous adipose tissue other than for aesthetic body contouring uses. | BK261326/0 | Tiger Aesthetics Medical, LLC 9630 S. 54 St. Franklin, Wisconsin 53132 | 05/13/2026 |
| Biowy Multi-Chamber Freezing Bag Set Container, Frozen Donor Tissue Storage | The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. | BK261343/0 | Biowy Corporation 27031 Vista Terrace | 04/29/2026 |
| Plasmacell-C Disposable Set Automated blood cell separator | The Plasmacell-C disposable set is intended for collection of plasma by membrane filtration. | BK251289/0 | Fresenius Kabi AG Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 | 03/31/2026 |
| Procleix Plasmodium Quality Control Assayed quality control material for clinical microbiology assays | Procleix® Plasmodium Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Plasmodium falciparum with the Procleix Plasmodium Assay. This product is intended to be used solely with the Procleix Plasmodium Assay, a licensed donor screening assay, performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device. | BK251300/0 | Grifols Diagnostic Solutions Inc. 10808 Willow Court San Diego, CA 92127 | 03/26/2026 |
| Biowy Multi-Chamber Freezing Bag Container, Frozen Donor Tissue Storage | The Biowy Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. | BK251308/0 | Biowy Corporation 27031/27002 Vista Terrace | 03/17/2026 |
| PlateletQuick PRP Automated blood cell separator | The PlateletQuick 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 point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK251299/0 | Forever Labs, Inc 600 S Wagner Road Ann Arbor, MI 48103 | 03/11/2026 |
| Hemanext ONE Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions | Blood container set used to process and store CP2D/AS-3 or ACD-A/AS-3 Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced. The Hemanext ONE system limits O2 and CO2 levels in the storage environment. Hemanext ONE is intended to process the following: Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have undergone in-line filtration and have been stored at 1-6°C for up to 67 hours. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. NOTE: REFER TO THE INSTRUCTIONS FOR USE TO SEE THE INFORMATION ABOVE IN TABULAR FORMAT. The Red Blood Cells must be processed with the Hemanext ONE system at room temperature (20-26°C). Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. The Hemanext ONE system is used for volumes no greater than 350 mL of LR RBC. | BK251294/0 | Hemanext Inc. 99 Hayden Avenue Building B, Suite 620 Lexington, MA 02421 | 03/06/2026 |
| NexSys PCS® Plasma Collection System with Persona Plus Technology Automated blood cell separator | The NexSys PCS® plasma collection system with Persona or Persona 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. | BK251292/0 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 | 02/20/2026 |
| PRF-Matrix System Automated blood cell separator | Indications for Use: The PRF-Matrix system is intended to be used for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood at point-of-care. Under the supervision of a healthcare professional, the PRP gel produced is topically applied for the management of cutaneous wounds such as diabetic ulcers, venous leg ulcers, and mechanically or surgically debrided wounds. | BK251232/0 | Royal Wound-X, Inc. MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01721 | 02/20/2026 |
| PUREGRAFT SYNC Adipose Filtration System Suction lipoplasty system | The Puregraft SYNC Adipose Filtration System is a sterile, single-use, closed system. The system consists of a harvest canister containing a Puregraft filtration bag, which is filled through the lid manifold and inlet/waste tubing sets. The Puregraft SYNC System is used in-line with a vacuum or aspirator apparatus and a suitable liposuction cannula. The Puregraft SYNC System is indicated for use in the harvesting, filtering, and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring. | BK251296/0 | Bimini Health Tech 8400 Belleview Dr Suite 125, Plano, TX 75024 | 02/12/2026 |
Precise Cell Concentration System Automated blood cell separator | The Precise Cell Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a mixture of peripheral blood and bone marrow aspirate (BMA) 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. | BK251168/0 | Arteriocyte Medical Systems, Inc. DBA Isto Biologics 45 South Street, Suite 3 Hopkinton, MA 01748 | 02/03/2026 |
| Multichem ID-HIV p24 Assayed quality control material for clinical microbiological assays | Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the heterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. | BK251207/0
| Techno-Path Manufacturing Ltd. Fort Henry Business | 01/02/2026 |