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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2008 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
ALYX Component Collection System Intended for use in blood collection facilities to collect and separate whole blood into its components BK080053 Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
12/22/2008
PrepaCyte(R)-CB Processing System Sterile, closed-bag processing system that easily and efficiently separates total nucleated cells (TNC), including stem cells, from human umbilical cord blood prior to public or private banking BK070067 BioE, Inc.
4280 Centerville Road
St. Paul , MN 55127
12/17/2008
Clotalyst and GPS III Platelet Concentrate Separation Kit with ACD-A,
Clotalyst and GPS III Mini Platelet Concentrate Separation Kit with ACD-A
For preparation of autologous serum that is to be mixed with the PRP and autograft or allograft bone for bone draft handling prior to application to the orthopedic surgical site BK080004 Biomet Biologics, Incorporated
56 East Bell Drive
Warsaw, Indiana 46582
12/19/2008
Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System The Double Syringe (ACP) System is used to facilitate the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. BK070069 Arthrex Incorporated
1370 Creekside Boulevard
Naples , FL 34108
12/12/2008
Sunquest Transfusion Manager v1.0 Blood Establishment Computer Software BK080021 Sunquest Information Systems, Inc.
250 S. Williams Blvd.
Tucson , AZ 85711
12/3/2008
HCLL Donor Blood Establishment Computer Software BK080061 Mediware Information Systems, Inc.
11711 West 79 th Street
Lenexa , KS 66214
12/2/2008
Trima Accel Automated Blood Component Collection System For use in collecting blood components for later transfusion into patients. Depending on disposable tubing set used, the system may collect products alone or in combination. See SE letter for list of products BK080058 CaridianBCT
10811 W. Collins Ave.
Lakewood , CO 80215-4498
11/25/2008
LIFECODES HLA Typing Kits (HLA-A, B, C, DQB, DRB, DRB1) for use with Luminex DNA typing of Class I and II HLA Alleles BK080050 Tepnel Lifecodes Corporation
550 West Ave.
Stamford , CT 06902
11/13/2008
MEDITECH Client Server Blood Bank module v5.6 Blood Establishment Computer Software BK080037 MEDITECH Medical Information Technology, Inc.
MEDITECH Circle
Westwood MA 02090
10/30/2008
Instrument Manager V8.07 Blood Establishment Computer Software BK080052 Data Innovations Inc.
120 Kimball Ave., Suite 100
South Burlington , VT 05430
10/28/2008
HCLL Transfusion, v3.0 Blood Establishment Computer Software BK080049 Mediware Information Systems, Inc.
1900 Spring Road, Suite 450
Oak Brook Service Center
Oak Brook, IL 60523
10/22/2008
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 BK080036 Siemens Medical Solutions Diagnostics
P.O. Box 2466
Berkeley , CA 94702-0466
10/20/2008
Cell Freeze Liquid Nitrogen Freezing Container Intended for storage, preservation and transfer of blood and blood components including peripherally derived stem cells, in liquid nitrogen to -196 C. BK060042 Charter Medical, Ltd.
3948-A Westpoint Blvd.
Winston-Salem , NC 27103
10/3/2008
AMICUS® Separator: Software 3.1 with EDI Export The AMICUS Separator is intended to be used for the simultaneous collection of platelet concentrate, plasma and red blood cells while maintaining an extracorporeal volume at or below 10.5 mL/kg and a post-count greater than 100,000 platelets/µL. The AMICUS Separator is intended to be used for automated collection of mononuclear cells. BK080048 Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
10/2/2008
Cell Freeze Liquid Nitrogen Freezing Container The Cell Freeze® Liquid Nitrogen Freezing Container is intended for the storage, preservation and transfer of peripherally derived stem cells, in liquid nitrogen to -196oC. The Cell Freeze® Liquid Nitrogen Freezing Container is provided sterile fluid path and intended for single use. BK060042 Charter Medical, Ltd.
3948-A Westpoint Blvd.
Winston-Salem , NC 27103
10/3/2008
Atreus Whole Blood Processing System Indicated for the automatic separation of one unit of CPD Whole Blood into two transfusable components BK080043 CaridianBCT, Inc.
10811 W. Collins Avenue
Lakewood , CO 80215-4498
9/29/2008
HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells Indicated for pre-storage leukoreduction of a single unit of CPD/AS-1 Red Blood Cells. BK080031 Hemerus Medical, LLC
5000 Township Parkway
Saint Paul , MN 55110
9/11/2008
MCS+ 9000 System Intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets BK080038 Haemonetics Corporation
400 Wood Road
Braintree , MA 02184 -9144
9/4/2008
Pool Results Manager Blood Establishment Computer Software BK080028 Rubin & Poor, Inc.
155 Maplewood Avenue #5
Maplewood , NJ 07040
9/3/2008
COBE Spectra Apheresis System,
Trima Accel Automated Blood Component Collection System
The COBE Spectra Apheresis system is intended for use in therapeutic apheresis procedures involving patients and in the collection of blood components from donors. The Trima Automated Blood Collection System is intended for use in automated blood component collection procedures. BK080035 CaridianBCT
10811 W. Collins Avenue
Lakewood , CO 80215-4498
8/29/2008
Amicus Separator System Intended to be used for the simultaneous collection of platelet concentrate, plasma and red blood cells while maintaining an extracorporeal volume at or below 10.5 mL/kg and a post-count greater than 100,000 platelets/mL BK080018 Fenwal Blood Technologies
Three Corporate Drive
Lake Zurich , IL 60047
8/26/2008
PLASMALINK The Plasma Pooling Bottle is used for the collection, storage, and shipment of plasma prior to fractionation. BK080033 Fenwal Blood Technologies
Three Corporate Drive
Lake Zurich , IL 60047
8/22/2008
Cymbal Automated Blood Collection System To collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced from autologous and allogeneic donors BK080025 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
8/15/2008
SoftBank II v23.2 Blood Establishment Computer Software BK080020 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
8/12/2008
Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 Blood Establishment Computer Software BK080017 LifeSouth Community Blood Centers Inc
4039 W. Newberry Road
Gainesville FL 32607
8/5/2008
Donor Screen HLA Class I and Class II To be used as an in vitro diagnostic kit in blood bank laboratories to screen blood donors for the presence of HLA Class I and Class II antibodies BK070045 GTI, INC
20925 Crossroads Circle
Waukesha WI 53186
7/30/2008
XM-ONE Transplantation Cross Match For use by professional laboratories in flow cytometric detection of antibodies in serum BK070011 AbSorber AB
Drottninggatan 33
Stockholm, SWEDEN
7/29/2008
ALBAcheck - BGS Reagent Control for Anti-D For use as a negative control in conjunction with Alba Bioscience monoclonal Anti-D reagents BK080027 ALBA Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT
UNITED KINGDOM
7/29/2008
Seraclone Control ABO+Rh
Coombscell-E MLB2
(1) For use as a negative control in manual blood grouping with Seraclone ABO+Rh reagents, (2) For control of the manual antiglobulin test, (3) To potentiate antigen-antibody reactions in manual antibody screening, antibody identification, crossmatching, and typing with reagents requiring anti-human globulin reagent BK080012 Biotest Medical Diagnostics GmbH
P.O. Box 102150
63267 Dreiech
Germany
7/23/2008
Alsever’s Solution (510(k) exempt but part of system)
Solidscreen II Control B
Solidscreen Negative Control
Tango Optimo Automated Blood Bank Analyzer System with version 3.1
For use in ABO, Rh(D) (including weak D and partial D testing), Rh phenotyping, Kell blood grouping, antibody detection/screening, crossmatching, and direct antiglobulin tests(DAT) in patient and donor testing BK080013 Biotest Medical Diagnostics GmbH
P.O. Box 102150
63267 Dreiech
Germany
7/23/2008
CytoTherm Plasma Thawing System Used to thaw one unit of plasma BK080019 CytoTherm LP
110 Sewell Avenue
Trenton, NJ 08610
7/16/2008
HLA EZ Type Assay for the molecular determination of HLA Class I and Class II alleles at low resolution, using PCR amplification of human genomic DNA. BK070034 GTI, Inc.
20925 Crossroads Circle
Waukesha , WI 53186
7/10/2008
ViroSeq HIV-1 Genotyping System v2.0 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. BK080026 Celera Diagnostics, LLC
1401 Harbor Bay Parkway
Alameda , CA 94502
7/10/2008
Donor Information System Intended to receive, analyze, and store data during the collection and distribution of human plasma that will be used in plasma-derived bio-pharmaceutical products. BK080016 BioLife Plasma Services LP
One Baxter Parkway
Deerfield , IL 60015
7/2/2008
The Atreus Whole Blood Processing System For the automatic separation and leukoreduction of one unit of whole blood into its blood components, red blood cells, plasma and residual leukocytes. BK080010 Gambro BCT
10811 W. Collins Ave.
Lakewood , CO 80215-4498
6/27/2008
ALYX Component Collection System For use in blood collection facilities to collect and separate whole blood into its components. BK080024 Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
6/24/2008
IntelliDOT Blood Product Administration Assist in positive patient identification for the transfusion of blood products. BK080006 IntelliDOT Corporation
13520 Evening Creek Drive North,
Suite 400
San Diego CA 92128
6/13/2008
PCS2 Plasma Collection System_Revision K Software Intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets BK080001 Haemonetics Corporation
400 Wood Road
Braintree , MA 02184 -9144
5/28/2008
Defense Blood Standard System (DBSS) 10.0.0 Blood Establishment Computer Software BK070035 Defense Blood Standard System
5205 Leesburg Pike, Suite 1000
Falls Church , VA 22041
5/22/2008
ePROGESA 5.0.1 Blood Establishment Computer Software BK080002 MAK-System
10 Avenue de la Grande Armee
75017 Paris
France
5/13/2008
DynaChip HLA Antibody Analysis System Provides analysis of HLA antibodies BK070041 Invitrogen Corporation
9099 North Deerbrook Trail
Brown Deer, WI 53223
4/30/2008
Blood Bank Information Management System (BBIMS)
V2.05.01
Blood Establishment Computer Software BK070065 Duley Hopkins and Associates
1200 Mountain Creek Road #215
Chattanooga , TN 37405
4/25/2008
ABBOTT PRISM Director V2.0 Assists laboratories by managing the sample test and retest function for multiple ABBOTT PRISM Systems. BK080015 Abbott Laboratories
100 Abbott Park Road
Abbott Park , IL 60064-3500
4/24/2008
Pall Acrodose PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter 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 BK080003 MEDSEP Corporation
16 Pepperwood Lane
Pepper Pike , OH 44124
4/18/2008
VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System BK070028 Ortho-Clinical Diagnostics, Inc
100 Indigo Creek Drive
Rochester, NY 14626-5101
4/10/2008
VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator
VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack
For the in vitro detection of antibodies to Human Immunodeficiency virus types 1 and/or 2 in human serum and plasma BP050051 Ortho-Clinical Diagnostics, Inc
100 Indigo Creek Drive
Rochester, NY 14626-5101
3/27/2008
Haemonetics PCS 2 Plasma Collection System, Wireless (W) Capable Modification Intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets BK060033 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
3/27/2008
HLA Fusion Software v 1.0 Accessory for the evaluation of test results from One Lambda Incorporated products for typing and antibodies detection BK070070 One Lambda, Inc.
21001 Kittridge Street
Canoga Park, CA 91303
3/10/2008
HaemoConnect (eLynx) Intended to facilitate the collection and consolidation of procedure activities and their subsequent download or transfer to permanent storage systems, such as donor management, simple electronic file archives and optical and/or paper based archived BK060051 5D Information Management
Suite 500
10025-102A Avenue
Edmonton, Canada T5J2Z2
3/6/2008
ElDorado Donor 1.0.0 Blood Establishment Computer Software BK070064 Wyndgate Technologies
4925 Robert J. Matthews Parkway
Suite 100
El Dorado Hills CA 95762
2/13/2008
Pall eBDS For the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of apheresis and whole-blood-derived platelet products BK070063 Medsep Corporation
1630 Industrial Park Street,
Covina, CA 91722
1/26/2008
TRUCISE Total System Provide a sterile weld between 2 pieces of polyvinyl chloride tubing with optional information module BK070018 Terumo Medical Corporation
125 Blue Ball Road
Elkton, MD 21921
1/22/2008
Fluido® Accessories: Fluido Air Guard, Fluido Compressor, Fluido IV-Pole and Fluido Pressure Chamber To be used as accessories to the Fludio Blood- and Fluid Warmer BK070055 The Surgical Company International
Terminalweg 19a
Amersfoort,
NETHERLANDS
1/15/2008