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.

2023 Biological Device Application Approvals
Tradename/Common Name	Description and Indication for Device	Submission ID	Manufacturer	Clearance Date
*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: Registering, deferring, merging, and qualifying donors. Registering bags. Recording the outcomes of the Donor History Questionnaire (DHQ). Recording medical screening data and phlebotomy information. Entering and evaluating test results in accordance with the decision rules. Processing units in components. Phenotype RBC/HLA searching and matching. Managing storage, inventory, and distribution of units. Managing therapeutic and autologous/directed donations requests.	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: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, plastic and reconstructive surgery Only legally marketed accessory items, such as syringes, should be used with the system. Any fat concentrated using this system is to be transferred back to the patient without any additional manipulation.	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: 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 prior to delivery to an LIS. Results can also be viewed remotely and edited prior to 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 for Capture-R results that is based upon the exclusion (rule-out) approach recommended in the Technical Manual (AABB).	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