2024 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 |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) Device Platelet And Plasma Separator For Bone Graft Handling |
The FG-001 Platelet Rich Plasma (PRP) Device is designed to be used for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is mixed with autograft or allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics. | BK241083/0 | OrthoAscent Regulatory Consultant/MEDIcept Inc. 200 Homer Avenue Ashland, MA 01721 |
09/26/2024 |
| Illuminate PRP Platelet And Plasma Separator for Bone Graft Handling |
Illuminate PRP 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. | BK241042/0 | Gale Force Aesthetics, LLC. 1644 Ramona Way Alamo, CA 94507 |
08/27/2024 |
| Blood Product Administration Module (BPAM 4-2023) 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 product and order information from a host system and a blood bank. The Module incorporates system-controlled logic that can require a positive match of the patient, the product to be administered, and information from the blood bank. The Module can also check a product's documented expiration date for appropriateness. Administration information entered in the Module is transmitted to the host system for storage. |
BK241081/0 | Epic Systems Corporation 1979 Milky Way Verona, WI 53593 |
08/21/2024 |
| Aptima® HIV-1 Quant Dx Assay Human Immunodeficiency virus (HIV) viral load monitoring test |
The Aptima® HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of human immunodeficiency virus type 1 (HIV-1) on the fully automated Panther® system and Panther Fusion® system. It is intended to be used as an aid in diagnosis for HIV-1 infection using appropriate HIV testing algorithms. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary infection. The Aptima® HIV-1 Quant Dx assay may also be used as a supplemental test, when it is reactive, to confirm HIV-1 infection in an individual whose plasma or serum specimen is reactive with an approved assay with an indication as an aid in the diagnosis of HIV-1 infection. The Aptima® HIV-1 Quant Dx assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in monitoring the effects of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels. The Aptima® HIV-1 Quant Dx assay quantitates HIV-1 RNA groups M, N, and O over the range of 30 to 10,000,000 copies/ mL. One international unit is equivalent to 0.35 copies of HIV-1 RNA for the 3rd HIV-1 WHO International Standard (subtype B, NIBSC code: 10/152). This assay is not intended to be used as a donor screening test for HIV-1. Performance of this test has not been evaluated for use in pregnant women or in a pediatric population. |
BK231025/0 | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
08/06/2024 |
| ImmuLINK (v3.2) Blood Establishment Computer Software and Accessories |
ImmuLINK is software intended for use in a blood banking environment to aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. ImmuLINK includes the following features and functions: • It provides the ability to create and print reports of tests and results. • It supports the ability to compare current results with previous results. • It supports the automatic ordering of reflex tests. • It provides a tool so that test results produced by a testing platform can be remotely validated before delivery to an LIS. Results can also be viewed remotely and edited before delivery to an LIS. • It provides bi-directional communication between an LIS and instrument platform(s). • It provides a tool to assist with antibody exclusion and identification for Capture-R results that is based upon the approach recommended in the Technical Manual (AABB). ImmuLINK does not provide diagnostic interpretations of antibodies; final clinical interpretation must be performed by a trained user. |
BK241080/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
08/06/2024 |
| 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. | BK241074/0 | One Lambda, Inc. 22801 Roscoe Boulevard West Hills, CA 91304 |
08/01/2024 |
| Blood Bank Information Management System (BBIMS) v3.01 Blood Establishment Computer Software and Accessories |
Blood Bank Information Management System (BBIMS) v3.01 is a Blood Establishment Computer Software that is intended for use by trained healthcare professionals for the following blood manufacturing activities: • Provides a donor-administered or staff entered health history questionnaire • Transfers donor responses collected from the progressive web application to the system’s network • Provides a staff entered physical assessment • Provides eligibility information regarding the suitability of a donor making a donation • Defers donors when they are prohibited from making a donation • Transfers donor information to Vista® Information System for donation optimization and receives procedure data information from Vista (when using certain automated blood collection systems) • Provides for maintenance and auditing of donor, donation and unit information • Provides for generation of donor notification letters • Provides for defining component preparation, modification and maintenance information • Provides for defining pooled products (e.g., platelets, cryoprecipitate) into single components • Transfers test orders and receives test results for all units processed, either through manual entry and/or donor sample testing software systems interfaces • Provides for labeling components based on Codabar and ISBT standards using HemaTrax® Unity Print Server to print 2x2, 4x2 and 4x4 labels • Provides for storing patient information during the manual crossmatch/consultation process • Provides for ordering products and storing information on inventories, orders, shipments, returns and imports |
BK241069/0 | Carter BloodCare 2205 Highway 121 South Bedford, TX 76021 |
07/09/2024 |
| BloodTrack Software 4.16.0 Blood Establishment Computer Software and Accessories |
The BloodTrack software is indicated for use to assist in positive patient identification for transfusion, to assist in the selection of blood products for patients and verify that the identified blood product was obtained. | BK241062/0 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 |
06/21/2024 |
| 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, haematopoietic 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. | BK231031/0 | NanoEntek, Inc. 851-14 Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 18531 Korea |
06/05/2024 |
| HemDonER 1.0.1 Blood Establishment Computer Software and Accessories |
HemDonER version 1.0.1 is a web application designed to manage plasma donation center activities. This application aims to improve the accuracy, efficiency, and safety of plasma donations by creating an organized secure system for managing the whole plasma donation process from registration of donors to collection of plasma and to the final distribution of the product. The HemDonER version 1.0.1 provides management controls and information service modules designed to assist the staff in the core functions by addressing various aspects of donor management and operational oversight. The HemDonER version 1.0.1 medical device includes the following modules:
HemDonER version 1.0.1 provides secure access controls to protect donor information, maintains confidentiality, and ensures data protection and privacy regulations. |
BK230958/0 | eDonorSoft, LLC 1619 Whitfield Street Sugarland, TX 77479 |
05/31/2024 |
| LipoGrafter Kit Suction lipoplasty system |
The LipoGrafter® Kit is indicated to facilitate Autologous Fat Transfer (AFT). AFT is the harvesting, sedimenting and transfer of autologous fat tissue back into the same patient following a medical procedure. The device is intended for use when the transfer of harvested adipose tissue is desired for aesthetic body contouring. The device is 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. Only legally marketed accessory items, such as syringes and cannulas, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. | BK231013/0 | Musculoskeletal Transplant Foundation (MTF Biologics) 125 May Street Edison, NJ 08837 |
05/16/2024 |
| Arthrex Thrombinator System (ABS-10080) Platelet And Plasma Separator For Bone Graft Handling |
The Thrombinator System for use with Arthrex PRP Systems (Arthrex Angel concentrated Platelet Rich Plasma cPRP System or Arthrex Double Syringe (ACP) System or Arthrex ACP Max™ Platelet-Rich Plasma (PRP) System) is designed for the preparation of autologous serum from anticoagulated or non-anticoagulated peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics. | BK241060/0 | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 |
04/24/2024 |
| BD Vacutainer® K2EDTA Blood Collection Tubes Tubes, Vacuum Sample, With Anticoagulant |
BD Vacutainer® K2EDTA Blood Collection Tubes are plastic, evacuated, sterile, single use in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing. BD Vacutainer® K2EDTA Blood Collection Tubes may be used for immunohematology testing, such as ABO blood grouping and Rh typing. The performance characteristics of these tubes have not been established for immunohematology testing in general; therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions. |
BK230980/0 | Becton, Dickinson & Company 1 Becton Drive Franklin Lakes, NJ 07417 |
04/17/2024 |
| SmartDMS Blood Establishment Computer Software and Accessories |
SmartDMS is a stand-alone Blood Establishment Computer Software (BECS) that is used to capture medical screening information, donor health assessment, capturing donation details, donor status management and for lookback capabilities. Additionally, SmartDMS is also used to capture lab testing results, barcode scanning, quality assurance, inventory, shipping, and product release. The SmartDMS operates as a stand-alone system and does not interface or interfere with the apheresis device or software. SmartDMS interfaces with PPTA’s Cross-Donation Check System (CDCS) to upload donations after completion of plasmapheresis. | BK230814/0 | Life Plasma, Inc. 5438 Perkiomen Avenue Reading, PA 19606 |
04/16/2024 |
| ALYX 2RBC-LR Kit Automated Blood Cell Separators |
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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BK230825/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 |
04/05/2024 |
| 3C OrthoPatch System Platelet And Plasma Separator For Bone Graft Handling |
The 3C OrthoPatch Device is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of a patient’s own peripheral blood. The PRP produced by the 3C OrthoPatch Device is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK230968/0 | Reapplix ApS Axteria Biomed Consulting, Inc. -------------(b)(6)------------ ------------(b)(6)------- |
04/02/2024 |
| NexLynk DMS Donor Management System 4.10.0 Blood Establishment Computer Software and Accessories |
The NexLynk DMS® Donor Management System is a record management software tool and database of information for use in Source Plasma establishments. The software assists in the manufacture of Source Plasma by performing the following functions:
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BK231036/0 | Haemonetics Corporation 125 Summer Street Boston, MA 02110 |
03/15/2024 |
| Rika Plasma Donation System (V2.1) Automated Blood Cell Separators |
TThe Rika Plasma Donation System is an automated blood cell separator device and single use sterile disposable set intended to collect source plasma with or without saline compensation. | BK231035/0 | Terumo BCT 10811 West Collins Avenue Lakewood, CO 80215 |
03/07/2024 |
| Aeon ACKit Platelet And Plasma Separator For Bone Graft Handling |
The Aeon ACKit 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. | BK231016/0 | Aeon Biotherapeutics Corp. 12F., No. 58, Ruihu St. Taipei City, Neihu District Taiwan, 11494 |
02/16/2024 |