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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2007 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
IDM Symphony System 2.0 Stand alone blood bank software BK070031 Information Data Management, Inc.
9701 West Higgins Road
Rosemont, IL 60018
12/13/2007
Vista Information System, Version 3.0 with Medical Review Module Stand alone blood bank software BK070066 Gambro BCT, Inc.
10811 W. Collins Ave.
Lakewood, CO 80215-4498
12/13/2007
Galileo Automated Blood Bank System Reverse ABO Group Assay Microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood BK070054 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
11/30/2007
Vortech Concentration System Production of platelet-poor plasma concentrate BK070036 Biomet Biologics, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46582-0587
11/21/2007
Immucor's WB corQC Used on the Galileo Echo Instrument for daily quality control of blood bank reagents BK070051 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30091-5625
11/16/2007
PROGESA 4.4h Modular, stand-alone software application to meet the needs of community blood banks or transfusion services BK070062 MAK-System
10 Avenue de la Grande Armee
France
10/26/2007
AXP AutoXpress Platform The ThermoGenesis AXP AutoExpress Platform is a cord blood cell processing system intended for laboratory use in combination with a specific and compatible single-use separation kit supplied by ThermoGenesis. The AXP system provides for automated, rapid, and consistent aseptic separation of cord blood in a closed environment using sterile, non-pyrogenic materials BK070006 ThermoGenesis Corp
2711 Citrus Road
Rancho Cordova, CA 95742
10/5/2007
TypeSafe Segment Dispenser The TypeSafe Segment Dispenser provides a safe means to puncture segments containing blood and convenient means to dispense blood from a segment into a test tube. It is for single specimen use BK070037 Typenex Medical LLC
303 East Wacker Dr
Chicago, IL 60601
10/5/2007
corQC Extend corQC Extend cell comprises five cells. They are group O, single donor, red blood cells. corQC Extend cells are used for the manual tube and automated (Galileo) assays for quality control evaluation of routine Rh and Kell blood grouping reagents BK070039 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
9/28/2007
Galileo Automated Blood Bank System with assays to perform red blood cell phenotying A microporcessor controlled instrument to automate immunohematology in vitro diagnostic testing of human blood using a microplate platform. It automates test processing, result interpretation and data management functions. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening such as syphilis and cytomegalovirus (CMV). BK070040 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
9/28/2007
UniMatch Plus Version 4.0 UniMatch Plus supports evaluation of HLA typing results. This submission is to update the device algorithm. BK070046 Invitrogen Corp
9099 North Deerbrook Trail
Brown Deer WI 53223
9/27/2007
Pall Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter and eBDS To pool leukocyte-reduce, and store ABO identical, whold blood -derived platelets in the CLX HP extended storage bag for up to 5 days after collection when used with the eBDS Sample Set in combination with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of pooled whole blood derived platelet products stored in plasma. BK070056 Medsep Corp
1630 Industrial Park Street
Covina, CA 91722
9/27/2007
Pall Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter The Pall AcrodoseTM PLUS System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter (Acrodose PL Leukocyte Reduction Filter), is indicated for use to pool, leukocyte-reduce, and store ABO identical, whole-blood-derived platelets in the CLX@HP extended storage bag for up to 5 days after collection when used with a device cleared by FDA for detection of bacterial contamination in pooled, whole-blood-derived platelets. BK070057 Medsep Corp
1630 Industrial Park Street
Covina, CA 91722
9/27/2007
AllSet Gold SSP PCR based HLA typing evaluation method designed to provide resolution of the HLA Class I (A, B, C) and Class II (DRβ DQβ) Loci using genomic DNA BK070038 Invitrogen Corp
9099 North Deerbrook Trail
Brown Deer WI 53223
9/26/2007
S-Monovette ACD-A Blood Collection System- Blood collection, processing, and transportation device producing an anticoagulated specimen for Blood Bank testing, histocompatibility and blood group determination. BK070029 Sarstedt, Inc
P.O. Box 468
Newton, NC 28658
9/21/2007
Autologel System The AutoloGel System is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of patient blood. The AutoloGel System is indicated for use in the treatment of non-healing wounds, such as diabetic, venous, and pressure ulcers, dehiscence wounds, and for the management of surgically-debrided wounds. BK060007 Cytomedix, Inc
416 Hungerford Dr
Rockville, MD 20850
9/20/2007
Olympus PK CMV-PA Test System and Controls
Olympus PK7300 Automated Blood Bank Analyzer
Automated PK7300 Blood Bank Analyzer for use in screening for antibodies to Cytomegalovirus. BK070030 Fujirebio Diagnostics, Inc
201 Great Valley Parkway, Malvern, PA 19355
9/20/2007
Platelet PGD Test System Rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in leukocyte reduced apheresis platelets (LRAP) as an adjunct quality control test following testing with a bacterial detection device cleared by the FDA for quality control testing of LRAP BK070044 Verax Biomedical Inc
377 Plantation St., Biotech 4
Worcester, MA 01605
9/17/2007
HEMERUS Medical LLC Leukocyte reduction filtration system BK070024 Hemerus Medical, LLC
5000 Township Parkway
Saint Paul, MN 55110
8/23/2007
AlbaQ-Chek Simulated Whole Blood Controls For use as controls of blood grouping reagents in column agglutination techniques BK070033 Alba Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT Scotland
United Kingdom
7/27/2007
CryoSeal FS System For use in the automated preparation of fibrin sealant from a single unit of autologous human plasma only in a closed, sterile fluid path. The autologous fibrin sealant prepared by this device is indicated for use as an adjunct to hemostasis on the incised liver surface in patients undergoing liver resection when control of bleeding by standard surgical techniques is ineffective or impractical. BP060001 ThermoGenesis Corp.
2711 Citrus Road
Rancho Cordova CA 95742
7/26/2007
Quality Donor System v2.1 Blood Establishment Computer Software BK070020 Talisman Ltd
421 Church Street NE. Suite F
Vienna VA 22180
7/16/2007
Vista Information System 3.0 Blood Establishment Computer Software BK070001 Gambro BCT, Inc.
10811 W. Collins Ave.
Lakewood, CO 80215-4498
6/27/2007
Pall eBDS For use with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of apheresis and single and pooled units of whole blood derived platelet products stored in plasma BK070004 Medsep Corp
1630 Industrial Park Street
Covina, CA 91722
6/26/2007
Olympus PK TP Reagent System For the quantitative screening of blood donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum or EDTA plasma using the OLYMPUS PK7200 and/or PK7300, Automated Microplate System BK060062 Fujirebio Diagnostics, Inc
201 Great Valley Parkway
Malvern, PA 19355
6/25/2007
Galileo Echo Automated Blood Bank System Microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood BK070016 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
6/14/2007
WB corQC A set of reagent red blood cells of varying antigenic and antibody makeup. WB corQC reagent red blood cells are incorporated as run controls with blood sample testing for the daily quality control of blood bank reagents on the Galileo Echo instrument. BK070015 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
6/14/2007
DAT Positive Control Cell To be used only with Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. BK070014 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
6/14/2007
Monoclonal Control To be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in Slide, Tube, and Microplate Tests BK070013 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
6/14/2007
GPS III Platelet Concentrate Separation Kit with ACD-A (also marketed in "Mini" and "Double Kit" packages) For the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by clinical use requirements. BK070026 Biomet, Inc
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46582-0587
6/6/2007
Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 Blood Establishment Computer Software BK060037 Cerner Corp
2800 Rock Creek Parkway
Kansas City MO 64117-2551
5/24/2007
ElDorado Donor Doc 1.0.0 Blood Establishment Computer Software - Staff or Self Administered Donor Health History Questionnaire BK070010 Wyndgate Technologies
4925 Robert J. Matthews Parkway
Suite 100
El Dorado Hills CA 95762
5/23/2007
Haemonetics PCS2 Plasma Collection System For use as an automated cell separator system and blood component collector in conjunction with a single use sterilized disposable set BK070019 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
5/23/2007
Olympus Bromelin; Olympus PK7300 Automated Microplate System; Olympus System Control The Olympus PK7300 Automated Microplate System is a fully automated analyzer intended exclusively for agglutination technology using Olympus terraced microplates. The PK7300 can be used to perform donor ABO/Rh grouping, including weak D testing, and Rh and Kell Phenotyping. The control is a specially prepared reagent, devoid of antibody activity, for use in parallel testing with ABO/Rh typing sera to differentiate between specific agglutination in non-specific reactions. BK060024 Olympus America, Inc
Diagnostic Systems Division
3131 West Royal Lane
Irving, TX 75063-3104
5/14/2007
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers BP050069/0 Roche Molecular Systems, Inc
4300 Hacienda Drive
PO. Box 9002
Pleasanton CA 94566-0990
5/11/2007
Abbott RealTime HIV-1 Amplification Reagent Kit,
Abbott RealTime HIV-1 Calibrator Kit,
Abbott RealTime HIV-1 Control Kit
Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers BP060002/0 ABBOTT Molecular, Inc
1300 E. Touhy Avenue
Des Plaines, IL 60018
5/11/2007
Patient Health Software 1.0 Blood Establishment Computer Software BK060035 MAK-System
10 Avenue de la Grande Armée
75017 Paris France
5/9/2007
CytoTherm Cryoprecipitate Thawer, Model CT-4T.6C A tabletop unit which can be attached to any cooling device to lower the thawing temperature. It can thaw up to 12 plasma bags at a time, keeping bag ports dry. BK060063 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
5/4/2007
Antibody Check 4.1 Blood Establishment Computer Software BK060056 Prescott Ideas, LLC
8960 E. Anna Place
Tucson, AZ 85710
4/23/2007
Pall Acrodose PL System, Platelet Pool and Store Set with in-line Leukocyte Reduction Filter Indicated for use to pool, leukocyte-reduce, and store whole-blood-derived platelets in the CLX HP extended storage bag for up to 5 days after collection when used with a device cleared by FDA for detection of bacterial contamination in pooled whole-blood-derived platelets. BK060040 Medsep Corp
16 Pepperwood Lane
Pepper Pike, OH 44124
4/12/2007
Pall eBDS For use with the Pall eBDS Oxygen Analyzer in the qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of leukocyte-reduced apheresis and single and pooled units of whole-blood-derived platelet products. BK060047 Medsep Corp
16 Pepperwood Lane
Pepper Pike, OH 44124
4/4/2007
PowerBANK Enterprise Edition 1.0 Blood Establishment Computer Software BK060014 Mosum Technology India PVT Ltd
55 Northern Blvd, Suite 200
Great Neck, NY 11021
3/30/2007
Morgan HLA SSP ABDR Typing Kit Provides the HLA-A, HLA-B and HLA-DRB typing results with a low to medium resolution by a DNA-based method. BK060060 Texas BioGene, Inc
635 Presidential Drive
Richardson TX 75081
3/22/2007
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Intended 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. BK070009 Siemens Medical School
Diagnostics
P.O. Box 2466
Berkeley, CA 94702-0466
3/19/2007
PROCLEIX NAT TRACKER Blood Establishment Computer Software BK070007 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
3/6/2007
Cymbal Automated Blood Collection System Intended to collect two units of leukoreduced red cells collected/stored in CP2D/AS-3 from autologous and allogeneic donors BK060057 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
2/28/2007
GPS II Platelet Concentration Separation Kit with ACD-A Plasmax Plasma Concentrator with GPS Mini Platelet Concentrate Separation Kit with ACD-A For the rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by clinical use requirements. BK070003 Biomet, Inc.
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46582-0587
2/22/2007
Procleix TIGRIS System for use with the Procleix WNV Assay Only intended for use with Procleix Assays for in vitro diagnostic use that have package inserts with Procleix TIGRIS System instructions BK060021 Gen-Probe, Inc
10210 Genetic Center Dr
San Diego CA 92121-4362
2/20/2007
Bd.id Patient Identification System for Transfusion Management V7.00 Blood Establishment Computer Software BK060046 Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes NJ 07417-1885
2/13/2007
ALYX Component Collection System: ALYX 2RBC-NLR Kit For use in blood collection establishments to collect and separate whole blood into its components BK060061 Baxter Healthcare Corp
1620 Waukegan Road
McGaw Park, IL 60085
2/9/2007
Donor-ID 3.0 Blood Establishment Computer Software BK060058 Healthcare-ID
1635 Barclay Blvd
Buffalo Grove IL 60089
2/8/2007
VeriSure Pro HBV DNA External Quality Control For use with the Procleix Ultrio Assay and no other HBV assay for the detection of hepatitis B virus (HBV) DNA in human plasma from donations of whole blood and blood components for transfusion BK060064 AcroMetrix Corporation
6058 Egret Court
Benicia, CA 94510
2/8/2007
MEDITECH MAGIC Blood Bank Software 4.9 Blood Establishment Computer Software BK060029 MEDITECH Medical Information Technology, Inc
MEDITECH Circle
Westwood, MA 02090
2/6/2007
TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 Automated Blood Grouping and Antibody Test System BK060066 Biotest AG
Postfach 10 20 40
D-63266 Dreiech,
Germany
1/17/2007
Instrument Manager 8.05.01.10 Intended to be used by trained laboratory personnel in a blood-banking environment as an aid in interfacing and managing data between blood bank automated instruments and Blood Establishment Computer Software (BECS) BK060053 Data Innovations Inc.
120 Kimball Ave., Suite 100
South Burlington VT 05430
1/5/2007
Sepax Cell Separation System and single use kits Allows the fast, automated and reproducible separation of cord blood in a closed and sterile environment BK060036 Biosafe SA
Biologics Consulting Group
1317 King Street
Alexandria, VA 22314
1/3/2007