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 in reverse chronological order.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| 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 |
| 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 |
| 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:
|
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 |