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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2006 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.


Note: Applications are listed with the most recent action at the top.

Tradename Description and Indication for Device Number Applicant Approval Date
SoftDonor 4.4. with DMSI 4.4 Blood Establishment Computer Software BK060059 SSC Soft Computer
34350 U.S. Hwy 19 N.
Palm Harbor, FL 34684
12/21/2006
Medi-Temp III, Model FW600 Blood/Fluid Warmer Intended to aid in the prevention of inadvertent hypothermia during administration of blood, blood products, and other fluids BK060050 Gaymar Industries, Inc
1700 Pennsylvania Avenue, N.W.
Washington, DC 20006-4706
11/7/2006
AmpliTrol III Unassayed positive quality control reagent for use with in vitro diagnostic tests for the detection of HIV-1 RNA, HCV RNA, and HBV RNA in human serum or plasma from donations of whole blood and blood components for transfusion BK060052 Blackhawk BioSystems, Inc.
12945 Alcosta Blvd.
San Ramon CA 94583
11/7/2006
Genetic Systems HIV-1/HIV-2 PLUS O Ortho Assay Protocol Disk Contains the pipetting parameters and analysis algorithms for Ortho Assay Software (OAS) and/or processing method for the Ortho Summit Processor (OSP) to run Bio-Rad's Genetic Systems HIV assay BK050044 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Hwy 202
P.O. Box 350
Raritan, NJ 08869-0606
11/3/2006
VistA Blood Establishment Computer Software (VBECS) 1.0 Blood Establishment Computer Software BK060043 Dept of Veterans Affairs
P.O. Box 7008
Hines, IL 60141-7008
10/19/2006
BloodTrack 4.1 Blood Establishment Computer Software BK060041 Neoteric Technology Ltd
205-1099 W. 8th Ave.
Vancouver British Columbia V6H 1C3
CANADA
10/17/2006
GenesisCS Component Concentrating System Designed to separate and individually aspirate chemicals and bodily fluids with minimal cross-contamination, particularly to sequester a high concentration of platelet-rich blood plasma for use in various medical procedures BK050055 Perfusion Partners & Associates, Inc
6227 Foxfire Lane
Fort Myers, FL 33912
10/13/2006
HemoCue Hb 301 System Quantitative point-of-care whole blood hemoglobin determination in primary care or blood donation settings using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. BK060048 HemoCue AB
Kuvettgatan 1
Angelholm, Sweden
10/5/2006
Pall Acrodose PL System, Platelet Pool and Store Set Empty Containers for the Collection & Processing of Blood/Blood Components BK060045 Medsep Corp
16 Pepperwood Lane
Pepper Pike, OH 44124
9/1/2006
Pall Acrodose PL System, Platelet Pool and Store Set with eBDS Empty Containers for the Collection & Processing of Blood/Blood Components BK060044 Medsep Corp
16 Pepperwood Lane
Pepper Pike, OH 44124
9/1/2006
ViroSeq HIV-1 Genotyping System For use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection BK060049 Celera Diagnostics, LLC
1401 Harbor Bay Pkwy
Alameda, CA 94502
8/31/2006
TANGO Automated Blood Bank Analyzer System For use in ABO and Rh blood group determinations for patient and donor testing, including on receipt, independent confirmation of donor unit labeling; Antibody screening for detection of unexpected red cell alloantibodies BK060034 Olympus America, Inc.
Diagnostic Systems Division
3131 West Royal Lane
Irving, TX 75063-3104
8/28/2006
LifeTec Elite 1.0 Blood Establishment Computer Software BK060032 SysTec Computer Associates, Inc.
28 North Country Rd
Mt. Sinai, NY 11766
8/21/2006
ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV) Human blood based control designed to be used as an independent, unassayed, external run control with in vitro tests for the detection of HIV-1 RNA, HCV RNA, HBV DNA, and West Nile Virus RNA (WNV) BK060030 BBI Diagnostics, A SeraCare Company
375 West Street
West Bridgewater, MA 02379
8/18/2006
CytoTherm Plasma Thawing System Tabletop frozen plasma thawing system BK060027 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
8/1/2006
MICROAMS Qualitative solid phase enzyme linked immunoassay (ELISA) designed to detect IgG Antibodies to donor-specific HLA class I and class II glycoproteins BK060038 GTI, INC
20925 Crossroads Circle
Waukesha WI 53186
7/28/2006
Talisman Phlebotomy System, Release 1.0 Blood Establishment Computer Software BK060031 Talisman Ltd.
421 Church Street NE. Suite F
Vienna VA 22180
7/27/2006
Life Trak / Donor 3.01 Blood Establishment Computer Software BK060019 Mediware Information Systems, Inc
4545 Fuller Drive
Suite 320
Irving, TX 75038
6/21/2006
ACCURUN 365 West Nile Virus RNA Positive Quality Control Used as an independent, unassayed, external run control with in vitro tests for the detection of West Nile Virus RNA BK060022 BBI Diagnostics, A SeraCare Company
375 West St
West Bridgewater, MA 02379
6/12/2006
Abbott PRISM Retest Server Blood Establishment Computer Software BK060028 Abbott Laboratories
100 Abbott Park Rd
Abbott Park , IL 60064-3500
6/7/2006
Chembio HIV Reactive/Nonreactive Controls
SURE CHECK HIV 1/2 ASSAY
For the detection of antibodies to HIV 1 & 2 in fingerstick whole blood, venous whole blood, and serum or plasma specimens BP050009 Chembio Diagnostic Systems, Inc
3661 Horseblock Road
Medford, NY 11763
5/25/2006
Chembio HIV 1/2 STAT-PAK ASSAY For the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. BP050010 Chembio Diagnostic Systems, Inc
3661 Horseblock Road
Medford, NY 11763
5/25/2006
E-Interview (eQue) 1.0.0 Blood Establishment Computer Software BK050060 Fifth Dimension Information Systems
10025-102A Ave
Suite 500
Edmonton, Canada
T5J 2Z2
5/24/2006
Haemonetics ACP 215 Glycerolization/Deglycerolization System Intended to glycerolize and deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for up to 6 days at 1-6°C prior to glycerolization BK060008 Haemonetics Corp
400 Wood Rd
Braintree, MA 02184
5/23/2006
Haemonetics MCS+ 8150 Apheresis System Used to collect blood components from allogeneic and autologous donors BK060023 Haemonetics Corp
400 Wood Rd
Braintree, MA 02184
5/23/2006
ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents For the qualitative determination of antibodies to the human immunodeficiency virus type 1, including group O, and/or type 2 in serum or plasma using the ADVIA Centaur System BP050030 Bayer HealthCare
511 Benedict Ave
Tarrytown, NY 10591
5/18/2006
Donor Information System (DIS) 3.2 Blood Establishment Computer Software BK060017 BioLife Plasma Services LP
One Baxter Parkway
Deerfield , IL 60015
5/9/2006
corQC Test System Daily Quality Control System for Routine Blood Bank Reagents BK060016 Immucor, Inc
3130 Gateway Drive
Norcross, A 30091-5625
5/9/2006
Fluido Blood and Fluid Warmer System Designed for use to warm blood and fluids before administration BK050058 The Surgical Co Int’l
Terminalweg 19a
Amersfoort, Netherlands
3821AJ
5/5/2006
Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System For the rapid preparation of autologous platelet-rich concentrate (PRC) from a small sample of blood at the patient's point of care BK060004 Smith & Nephew, Inc
1450 Brooks Road
Memphis, TN 38116
5/2/2006
Galileo Automated Blood Bank System with Capture-S Syphilis Screening Assay Designed to fully automate immunohematology in vitro diagnostic testing of human blood BK060009 Immucor, Inc
3130 Gateway Drive
Norcross , GA 30091-5625
4/11/2006
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Software for detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs and aid in monitoring and treating HIV infection BK060015 Bayer HealthCare Diagnostics Division
P.O. Box 2466
Berkeley, CA 94702-5828
3/21/2006
Procleix System Blood Establishment Computer Software BK060012 Gen-Probe
10210 Genetic Center Dr
San Diego, CA 92121-4362
3/15/2006
GranType Alternative to serological typing of the HNA-1 polymorphism in granulocytes BK050054 GTI, Inc
20925 Crossroads Circle
Waukesha WI 53186
3/2/2006
Chiron Procleix NAT Tracker 3.0 Blood Establishment Computer Software BK060005 Chiron Corp
4560 Horton St
Emeryville, CA 94608
3/1/2006
COBE Angel Whole Blood Separation System Intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets produced can be used for diagnostic tests. The platelet rich plasma from the COBE® Angel Whole Blood Separation System can also be mixed with autograft and/or allograft bone prior to application to an orthopedic site as deemed necessary by the clinical use requirements BK060010 COBE Cardiovascular, Inc
14401 West 65th Way
Arvada, CO 80004-3599
2/27/2006
BD Vacutainer Plus K2EDTA Tubes; BD Vacutainer Plus Serum Tubes; BD Vacutainer SST Glass Tubes; BD Vacutainer SST II Advance Tubes; BD Vacutainer SST Plus Tubes Intended for routine blood donor screening and diagnostic testing of serum for infectious disease. The performance characteristics of these tubes have not been established for infectious disease testing in general; therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions BK050036 Becton, Dickinson & Co
1 Becton Dr, MC 300
Franklin Lakes, NJ 07417
2/24/2006
Cascade Medical FIBRINET System Intended for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP can be mixed with autograft and allograft bone prior to the application to an orthopedic surgical site as deemed necessary by the clinical use requirements BK060006 Cascade Medical Enterprises, LLC
20 Greenup Ct
Wayne, NJ 07470
2/16/2006
BD HLA-B27 System Qualitative two-color direct immunofluorescence method for the rapid detection of HLA-B27 antigen expression in erythrocyte-lysed whole blood (LWB) using the BD FACSCanto flow cytometer, or the BD FACSCalibur, BD FACSort, or BD FACScan flow cytometers BK050073 BD Biosciences
2350 Qume Drive
San Jose CA 95131-1807
2/16/2006
HLA Visual Software version 1.0 Accessory for the evaluation of test results from One Lambda Inc products for molecular typing and antibodies detection BK050070 One Lambda, Inc
21001 Kittridge St.
Canoga Park CA 91303
1/30/2006
HLATools Software, Version 1.0 To aid in assigning Major and /or Minor Histocompatibility Compexes BK050071 One Lambda, Inc
21001 Kittridge St.
Canoga Park CA 91303
1/30/2006
Pall Acrodose PL System Intended to be used to pool and store whole-blood-derived, leukocyte-reduced platelets in the CLX HP extended storage bag for up to 5 days BK050074 Medsep Corporation
19 Pepperwood Lane
Pepper Pike, OH 44124
1/26/2006
ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) Alternatives to platelet serological testing and an adjunct to HLA matching in selecting compatible platelets for recipients BK050040 GTI, INC
20925 Crossroads Circle
Waukesha, WI 53186
1/20/2006
Genetic Systems HbsAg EIA 3.0 Ortho Assay Protocol Disk Contains the pipetting parameters and analysis algorithms for Ortho Assay Software and/or processing method for the Ortho Summit Processor to run Bio-Rad's Genetic Systems HBsAg EIA 3.0, the assay specified on the disk label BK050046 Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
1/13/2006