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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2014 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.

Description and Indication for DeviceSubmission IDManufacturer
Clearance Date

ALBAzyme™ Papain Solution kit

Stabilized Enzyme Solutions

The ALBAzyme Papain Solution Kit is used for the preparation and testing of papainized red blood cells.


ALBA Bioscience Limited (doing business as Quotient) 21 Ellen's Glen Road Scotland, UNITED KINGDOM 



Quality Control Kits for Blood Banking Reagents

Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screening test systems.


Hemo bioscience
801 Capitola Drive, Suite 9
Durham NC 27713


Evicel Application Device

Syringe, piston

The EVICEL Application Device is intended for the simultaneous topical application of the two biological components of EVICEL Fibrin Sealant onto the surface.


Omrix Biopharmaceuticals Ltd.
PO Box 151, Route22 West Somerville NJ 08876


BloodTrack 4.7.0

Stand alone Blood Bank Software

BloodTrack is an electronic information management system intended for use in healthcare and collection facilities by trained healthcare professionals to help prevent latent errors by monitoring the reception, handling, transportation, and transfusion of blood, blood products and plasma derivatives (collectively referred to as Units).


Haemonetics Corporation
Software Solutions 4925 Robert J. Matthews Parkway El Dorado Hills CA 95762


Haemonetics PCS2 Plasma Collection System

Automated Blood Cell Separators

The PCS2 System 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 PCS2 System LN6002 automated cell separator with NA software revision J and earlier include source plasma, plasma for reinfusion and plasma & leukocytes.


Haemonetics Corporation 400 Wood Road Braintree MA 02184


Trima Accel System
Version 6.4

Automated Blood Cell Separators

The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients.


Terumo BCT, Inc 10811 W. Collins Ave. Lakewood CO 80215


Procleix Xpress® System

Stand alone Blood Bank Software

The Procleix Xpress® System (Software and Instrument) is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids.  The Procleix Xpress® System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix® systems.


Grifols Diagnostic Solutions Inc. 4560 Horton Street, M/S N-200 Emeryville CA 94608


MCS+ 8150

Automated Blood Cell Separators

The MSC+ 8150 device may be used to collect the following blood components from allogeneic and autologous donors: not listed here.


Haemonetics Corporation
400 Wood Road Braintree MA


Spectra Optia

Apheresis System

Mononuclear cell (MNC) collection from peripheral blood.


TERUMO BCT 10811 W. Collins Ave Lakewood CO 80215


Uni-Gold Recombigen® HIV-1/2

HIV Detection Test

To request approval for the introduction of a true procedural control line and improved conjugation process to the device


Trinity Biotech IDA Business Park
2823 Girts Road
Jamestown, NY



Stand alone Blood Bank Software

Is a web-based application indicated for use by trained personnel to aid and assist in the operation and management of plasma donation centers.


Haemonetics Corporation 4925 Robert J Mathews Parkway El Dorado Hills CA 95762


SoftBank Version 25.5

Stand alone Blood Bank Software

The SoftBank Version 25.5 application is a decision support software device that requires knowledgeable user intervention to document certain steps and events in a transfusion service.


SCC Soft Computer 5400 Tech Data Drive Clearwater FL 33760


Centrepid Platelet Concentrator 

Platelet And Plasma Separator For Bone Graft Handling

Rapid Preparation of PRP from small blood sample at patient's point of care


Cellmedix Holdings, LLC.19 Park Drive Franklin NJ 7416


Sunquest Transfusion Manager version 2.0

Standalone Blood Bank Software

Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services.  Transfusion Manager helps users manage the following transfusion service activities:
-Positively identify transfusion recipients
-Match blood products to recipients
-Record recipient pertinent transfusion information
-Record recipient transfusion reactions and caregiver comments


Sunquest Information Systems, Inc.
205 S. Williams Blvd
Tucson AZ  85711


BeadCheck HEA Positive Control  

BeadCheck HEA Positive Control

The BeadCheck HEA Positive Control consists of AA and BB synthetic plasmid pools which are intended for use as assayed positive controls for the HEA BeadChip Kit. The Positive Control is designed to demonstrate that the HEA BeadChip Kit will detect all A
and B forms of each genetic marker listed. The Positive Control is not intended to monitor the DNA extraction step of the HEA BeadChip Kit.


BioArray Solutions, Ltd.
35 Technology Drive Warren NJ 07059


BioArray Imaging System (AIS) 400C   Instrumentation for Clinical Multiplex Test Systems

It is an automated image acquisition system designed for use with BioArray Solutions BeadChips Kits


BioArray Solutions, Ltd.
35 Technology Drive Warren NJ 07059


DG Reader  

Manual blood grouping and antibody test systems

It is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards.


Diagnostic Grifols, Passeig Fluvial, 24,
Parets Del Valles,
Barcelona, SPAIN


Immucor PreciseType™  

Human Erythrocyte Antigen Molecular BeadChip Test Molecular erythrocyte typing test

PreciseType, version 1.2, is a deoxyribonucleic acid (DNA) microarray assay that utilizes polymerase chain reaction (PCR) amplification of genomic DNA coupled with an elongation mediated multiplexed analysis of polymorphisms (eMAP) platform to determine allelic variants of human erythrocyte antigens (HEA). PreciseType consists of the PreciseType assay kit, the Array Imaging System instrument, and the BioArray Information Systems Interpretive Software.


BioArray Solutions, Ltd. 35 Technology Drive, Warren, NJ 07059


Blood Administration Version 1800/Stand alone Blood Bank Software

Manage all processes associated with the handling and utilization of blood units and components within the hospital.


CPSI 6600 Wall Street Mobile AL 36695


Procleix NAT Manager Software (Version 1.1) /Stand alone Blood Bank Software

Procleix NAT Manager® Software is designed to collect data from Procleix¿ assays, instruments, and pooling software, which allows operators to track individual donor samples (organ and tissue donors, including cadaveric samples) and link them to the appropriate test results. The software collates the results of pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). It is intended to be used by trained Blood Establishment and Clinical Diagnostics lab personnel01


STRATEC Biomedical UK Limited1 Barberry Court, Callister Way


DG Gel Extended Control /Quality Control Kits for Blood Banking Reagents

For use in quality control with DG Gel 8 technique. DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures for:Determination of ABO, Rh, K antigens; Determination of the appropriate ABO blood group antibodies


Medion Grifols Diagnostics AG Bonnstrasse 9 Duedingen


DoVac Elite v 2.0 /Stand alone Blood Bank Software

The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions. All information from a donation can be reproduced and printed to hard copy. Specific unit/product level holds generated from DoVac Elite v2.0 are displayed in the LifeTec Elite v2.0 system


IT Synergistics, LLC 115 Tree Street Flowood MS 39232


Vista Information System Version 3.2/ Stand alone Blood Bank Software

Provide capability for the operator to identify current and new donors. Collection of data from apheresis procedures performed on Terumo BCT Trima Systems. Provide manual capability for the operator to enter procedure data for procedures performed on Terumo BCT Spectra Systems and non-Terumo BCT Systems including whole blood collections. Support for 21 CFR Part 11-compliance (Electronic Record/ Signature). Maintain a complete record of blood component donation including supplies used. Support for managing whole blood donation including use of Copper Sulphate tests.


Terumo BCT, Inc10811 W. Collins Ave. Lakewood CO 80215


DSM Biomedical PRP Device

Platelet And Plasma Separator For Bone Graft Handling

The DSM Biomedical PRP Device is designed to be used for the safe and rapid preparation of autlogous platelet-rich-plasma (PRP) from a small sample of 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 for improving handling characteristics.


DSM BIOMEDICAL 735 Pennsylvania Drive Exton PA 19341

Lic# 569260


SmartPrep2 System

Platelet And Plasma Separator For Bone Graft Handling

Safe & Rapid preparation of autologous PRP from small sample of blood at patients point of care


Harvest Technologies 40 Grissom Road Plymouth MA 02360

Lic# 571487


Trima Accel System, Version 6.2

Automated Blood Cell Separators

Updates to Indications for Use Statement and Operator's Manual


TERUMO BCT 10811 W. Collins Ave Lakewood CO 80215

Lic# 575216


Blood Product Administration Module version 0.9

Stand alone Blood Bank Software

It is intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion.


Epic Systems Corporation 1979 Milky Way Verona WI 53593

Lic# 564476


AsiManager AT

Densitometer/Scanner (Integrating, reflectance, tlc,
radiochromat) Clinica

The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT
is designed to provide
standardized test interpretation, and provides for storage, retrieval, and transmittal of the test results.
It is intended to be acquired, possessed, and used only by health care professionals.


Arlington Scientific, Inc. 1840 North Technology Dr.
Springville, UT 84663


Cymbal Automated Blood Collection System

Automated blood cell separator

Is intended to collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, from autologous and allogeneic donors.


Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114



Automated Blood Grouping and Antibody Test Systems

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, Compatibility Tests, and Direct Antiglobulin Tests.


Diagnostic Grifols,
S. A.
Passeig Fluvial, 24
08150 Parets del Valles Barcelona, SPAIN


Autologous Platelet Integrated Concentration (APIC) System

Platelet And Plasma Separator For Bone Graft Handling

System is indicated for the rapid preparation of autologous platelet rich plasma from a small sample of blood at the
patient's point of care. The platelet rich plasma is mixed with autograft and/or allograft bone prior to application to a bony defect for improving bone graft handling characteristics.


Cytonics Corporation
555 Heritage Drive, Suite 115
Jupiter, FL 33458


Integrated Blood Bank Information System, version
3.0 (IBBIS)

Standalone Blood Bank Software

IBBIS version 3.0 is a computerized system of programs intended for use by trained blood bank personnel as an aid
in the entry and tracking of information related
to blood donor registration donation product manipulation, donation product distribution (shipping and receiving) and donor testing.


LifeSouth Community Blood Centers
4039 W. Newberry Road
Gainesville, FL 32607


Spectra Optia Apheresis System

Blood component separator

Blood component separator, may be used to perform procedures for collection of MNC and PMN from peripheral


Terumo BCT 10811 W. Collins Ave Lakewood, CO 80215-4440


Endoret Kit for
Platelet and Plasma Separator

Platelet and Plasma Separator

The system is designed to be used for the safe and rapid preparation of autologous


B.T.I Biotechnology Institute, S.L.
Leonardo DaVinci 14
Parque Tecnologico De Alava
Minano,   SP