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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2005 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.


Tradename Description and Indication for Device Number Applicant Approval Date
BacT/ALERT BPN Culture Bottle Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC) BK050043 bioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
12/27/2005
BacT/ALERT BPA Culture Bottle Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC) BK050037 bioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
12/27/2005
System for Plasma Identification (SPI) 2.0.0 Blood Establishment Computer Software - Plasma Tracking and Post Donation Test Results BK050078 ZLB Behring AG
Wankdorfstrasse 10
Postfach 3000 Bern 22
Switzerland
12/22/2005
VeriSure Pro West Nile Virus (WNV) RNA External Quality Controls:
VeriSure Pro WNV RNA Negative External Quality Control
VeriSure Pro WNV RNA Positive External Quality Control
For use with the Procleix System for the detection of West Nile Virus (WNV) in human plasma from donations of whole blood and blood components for transfusion. The VeriSure Pro WNV RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of the Procleix Assay and has the potential for detecting systematic deviations of the Procleix assay for the qualitative determination of WNV. BK050061 AcroMetrix Corp
6058 Egret Court
Benicia, CA 94510
12/21/2005
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 leukocyte reduced apheresis and whole blood derived platelet products BK050075 Medsep Corp
19 Pepperwood Lane
Pepper Pike, OH 44124
12/20/2005
TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0) For use in ABO and Rh 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 BK050076 Olympus America Inc
Diagnostic Systems Division
3131 West Royal Lane
Irving TX 75063-3104
12/16/2005
BloodTrack Courier 3.2 Blood Establishment Computer Software BK050059 Neoteric Technology Ltd
205-1099 W. 8th Ave
Vancouver, Canada
12/13/2005
UltraChek Reference Controls - Product Code GLK
UltraCrit Hematocrit Measurement Device - Product Code GKF
To monitor and evaluate the analytical performance of the UltraCrit device for the measurement of hematocrit; to quantitatively measure hematocrit (Hct) levels in human whole blood for the purpose of screening suitable blood donors for the blood banking industry BK050056 Separation Technology, Inc
1096 Rainier Drive
Altamonte Springs, FL 32714-3855
12/12/2005
Aldecount Progenitor Cell Enumeration Kit For general diagnostic purpose to enumerate ALDH (bright) SSC (lo) cells in fresh or frozen clinical samples. These samples can be from normal donors, donors mobilized with granulocyte stimulating factor (G-CSF) or some other mobilizing agent or patients that have been mobilized or treated with chemotherapeutic agents. BK050052 STEMCO Biomedical, Inc
2810 Meridan Pkwy
Suite 148
Durham, NC 27713
12/2/2005
MCS+9000, SDP revision E software, 994CF-CPP series disposable sets To collect one unit of platelets, leukocyte reduced (with or without plasma). Additionally, the set may be used to collect two units of platelets, leukocyte reduced. The collected platelets may be stored up to 7 days and must be coupled with 100% screening for bacterial contamination using a device cleared for that purpose with its recommended method prior to transfusion) BK050047 Haemonetics Corp
400 Wood Road
Braintree, MA 02184-9144
11/21/2005
Procleix System for the Procleix WNV Assay For use as an integrated software/equipment system to be used in conjunction with blood screening assays BK050042 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
11/15/2005
Galileo Automated Blood Bank System
Capture-CMV
Microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo automates test processing, result interpretation and data management functions. The Galileo is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing and infectious disease screening such as syphilis and cytomegalovirus (CMV) BK050050 Immucor, Inc
3130 Gateway Drive
Norcross GA 30091-5625
11/14/2005
AMICUS Separator System Simultaneous collection of platelet concentrate, plasma and red blood cells BK050038 Baxter Healthcare Corp
1620 Waukegan Road
McGaw Park, IL 60085
11/3/2005
BD HLA-B27 kit Qualitative two-color direct immunofluorescence method for the rapid detection of HLA-B27 antigen expression in erythrocyte-lysed whole blood (LWB) using the BD FACSCalibur, BD FACSort, or BD FACScan flow cytometers BK050062 BD Biosciences
2350 Qume Drive
San Jose CA 95131-1807
10/27/2005
SoftDonor 4.3 with SoftScape 1.2.0 Blood Establishment Computer Software - Blood Donor Service Software BK050045 SCC Soft Computer
34350 U.S. Highway 19 North
Palm Harbor FL 34684
10/26/2005
Leucolab LCG2 Leukoreduction System for Red Blood Cells Indicated for the leukoreduction of a single unit of red cells, at room temperature (20 to 24 C) within 8 hours of collection, or at 1 to 6 C up to 3 days after collection. The storage period for the Leukoreduced Red Blood Cells is determined by the anticoagulant or preservative solution used in their manufacture BK050041 MacoProductions S.A.S.
2335 Massey Lane
Decatur, GA 30033
10/12/2005
Monitor Blood Administration Module Release 24.0 Blood Establishment Computer Software BK050001 Healthcare Management Systems, Inc
3102 West End Avenue, Suite 400
Nashville TN 37203
9/28/2005
Pall Acrodose PL System, Platelet Pool and Store Set with eBDS Pall Platelet Pool and Store Set 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 and, with the Pall eBDS Oxygen Analyzer, in qualitative procedures to detect aerobic and facultative anaerobic microorganisms (bacteria) in the pooled platelets for quality control purposes BK050034 Medsep Corp
1630 Industrial Park Street
Covina, CA 91722
9/28/2005
Haemonetics MCS + 8150 Apheresis System Intended to be used with the 2 RBC-F protocol and the 832F disposable set to collect two units of filtered red cells from autologous and allogeneic donors. Filtration must be done within 8 hours if the red cells are at room temperature or within 72 hours if the red cells are stored at 1-6 C BK050048 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
9/27/2005
Quant-Rho FITC Anti-D for Fetal Cell Assay For the estimation of fetomaternal haemorrage by in vitro labeling of RhD+ve cells for analysis by flow cytometry BK050005 ALBA Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT
Scotland, UK
9/27/2005
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Blood Establishment Computer Software BK050035 Bayer HealthCare Diagnostics Division
P.O. Box 2466
Berkeley, CA 94702-5828
9/20/2005
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. It 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 BK050033 COBE Cardiovascular, Inc
14401 West 65th Way
Arvada, CO 80004
8/22/2005
BloodTrack SafeTx Version 2.0 Intended for use in hospitals by healthcare professionals trained in administration of blood to increase transfusion safety by providing positive patient ID at bedside when samples are collected, and at time of transfusion of blood or blood products BK050032 Neoteric Technology Ltd
205-1099 W. 8th Ave
Vancouver, Canada
8/16/2005
CareChek Patient Identification System, CareChek TX, Version 1.0 Blood Establishment Computer Software BK040053 Korchek Technologies, LLC
770 Plattsville Road
Trumbull, CT 06611
8/12/2005
Charter Medical Transfer Set To obtain an aliquot of blood or blood components and/or to perform a sterile transfer of blood or blood components from one container to another BK050021 Charter Medical, Ltd
3948-A Westpoint Blvd
Winston-Salem, NC 27103
7/22/2005
GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory For the safe and rapid preparation of autologous platelet-rich-plasma (PRP) and concentrated platelet poor plasma (PPPc) from a small sample of blood at the patient's point of care BK050016 Biomet, Inc
P.O. Box 587
56 East Bell Drive
Warsaw, IN 46582
7/20/2005
IDM Prelude System, Version 1.1 Blood Establishment Computer Software BK050014 Information Data Management, Inc
9701 W. Higgins Rd
Rosemont, IL 60018
7/18/2005
LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 100 Qualitative test (in vitro diagnostic kits) for the DNA typing of Class I and Class II HLA alleles BK050003 Tepnel Lifecodes Corp
550 West Avenue
Stamford, CT 06902
7/18/2005
LABScreen Software Assists in determining the presence or absence of HLA antibodies BK050008 One Lambda, Inc
21001 Kittridge St
Canoga Park, CA 91303
7/8/2005
Donor Information System (DIS) 3.1 Blood Establishment Computer Software BK050029 BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015
7/7/2005
Greiner Vacuette No Additive Tubes Collect, transport, and process blood for testing serum or clotted red blood cells in the immunohematology laboratory, i.e. red cell grouping, Rh typing and antibody screens BK050026 Greiner Bio-One North America, Inc
4238 Capital Drive
Monroe, NC 28110
7/7/2005
Greiner Vacuette Clot Activator Tube Collect, transport, and process blood for testing serum or clotted cells in the immunohematology laboratory, i.e. red cell grouping, Rh typing and antibody screens BK050028 Greiner Bio-One North America, Inc
4238 Capital Drive
Monroe, NC 28110
7/7/2005
Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 Blood Establishment Computer Software BK050018 GE Medical Information Technologies
540 Northwest Highway
Barrington, IL 60010
6/13/2005
BBCS Mobile Application 5.0M Blood Establishment Computer Software BK050013 Blood Bank Computer Systems, Inc
1002 15th St SW
Suite 120
Auburn, WA 98001-6502
6/1/2005
Dynal RELI SSO HLA-DRB1 Typing Kit
(For use as a manual assay or with the AutoRELI 48 instrument)
Typing System for PCR target amplification, hybridization of the amplified products to an array of immobilized sequence-specific oligonucleotide probes, and detection of the probe-bound amplified product by color formation BK050012 Dynal Biotech Ltd
11 Bassendale Road
Croft Busines Park
Bromborough, Wirral
CH62 3QL
United Kingdom
5/18/2005
LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell Filter for Red Blood Cells in additive solution Leukoreduction of one unit of red blood cells in additive solution at ambient temperature BK050020 Baxter Healthcare Corp
1620 Waukegan Road
McGaw Park, IL 60085
5/17/2005
HCLL Donor 1.0 Blood Establishment Computer Software BK050011 Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving TX 75038
5/10/2005
VeriSure Pro External Quality Controls Unassayed human plasma-based quality controls intended for use with the Procleix HIV-1/HCV assay for the detection of human immunodeficiency virus type 1 RNS and hepatitis C virus RNS in human plasma from donations of whole blood and blood components for transfusion BK040060 AcroMetrix Corp
6058 Egret Court
Benicia, CA 94510
5/3/2005
Procleix System Intended for use as an integrated software / equipment system to be used in conjunction with blood screening assay developed and manufactured by Gen-Probe BK050007 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
4/29/2005
ACP 215 Glycerolization/Deglycerolization System Amend the current frozen storage temperature from -80 oC to -65 oC BK050006 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
4/14/2005
Leukotrap SC RC Filtration System To be used for leukocyte reduction and storage of a single unit of packed red blood cells or whole blood BK050015 MEDSEP Corp
1630 Industrial Park St
Covina, CA 91722
4/14/2005
Procleix Optiva RAS Intended for use in the licensed / registered Procleix Assays BK050004 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
4/8/2005
TSCD-II Terumo Sterile Tubing Welder To provide a sterile weld between 2 pieces of polyvinyl Chloride (PVC) tubing in combinations of dry/dry, wet/dry, and wet/wet tubing BK040082 Terumo Medical Corp
125 Blue Ball Road
Elkton, MD 21921
4/5/2005
Tango Automated Blood Bank Analyzer System Intended for use in ABO/Rh Blood Grouping determinations for patients and donors; independent confirmation of donor labeling; antibody screening for the detection of unexpected RBC alloantibodies BK040070 Olympus America Inc,
Diagnostic Systems Division
3131 West Royal Lane
Irving, TX 75063-3104
3/22/2005
COBE Spectra Apheresis System & Trima Automated Blood Component Collection System Change the recommended storage time of platelets collected with their apheresis systems from 5 to 7 days when tested for bacterial contamination using the bioMerieux BacT/ALERT Microbial Detection System BK040086 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
3/15/2005
ALYX Component Collection System For the collection of Single Unit Red Blood Cells with Concurrent Plasma BK040084 Baxter Healthcare Corp
1620 Waukegan Road
McGaw Park, IL 60085
3/15/2005
BBCS Lab Interface Application (BBCS Lab) 5.0L Blood Establishment Computer Software BK040087 Blood Bank Computer Systems, Inc
1002 15th St. SW, Suite 120
Auburn, WA 98001-6502
2/15/2005
Sahara-TSC To thaw and/or warm leukapheresis products from mobilized donors BK040080 Sarstedt, Inc
P.O. Box 468
Newton, NC 28658-0468
2/9/2005
Aldecount Progenitor Cell Enumeration Kit For general diagnostic purposes to enumerate ALDHbright SSClo cells in fresh or frozen clinical samples from normal donors, donors mobilized with granulocyte colony stimulating factor (G-CSF) or some other mobilizing agent or patients that have been mobilized or treated with chemotherapeutic agents BK040075 Stemco Biomedical, Inc
2810 Meridian Parkway
Suite 148
Durham, NC 27713
1/6/2005