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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2009 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
TRUGENE HIV-1 Genotyping
Kit and OpenGene DNA
Sequencing System

Blood Establishment Software BK090077 Siemens Healthcare
Diagnostics Inc.
P.O. Box 2466
Berkeley, CA 94702
12/28/2009
Sanguin Aurora version 2.0 Blood Establishment Software BK090061 Sanguin International
1020 Sherman Avenue
Hamden, CT 06514
12/22/2009
VITROS Immunodiagnostics
Products Anti-HIV 1+2
Calibrator and Reagent Pack
HIV Detection Test BP050051/019 Ortho-Clinical Diagnostics, Inc
100 Indigo Creek Drive
Rochester, NY 14626-5101
12/10/2009
InterSol Solution For the storage of apheresis platelets for up to 5 days BN080041 Fenwal Inc
Three Corporate Drive
2nd Floor
Lake Zurich, IL 60047
12/9/2009
Integrated Blood Bank Information System Blood Establishment Software BK090064 LifeSouth Community Blood Centers Inc.
4039 W. Newberry Road
Gainesville, FL 32607
12/8/2009
Test Result Interface for ElDorado Donor An adjunct device to ElDorado Donor, aiding in the transfer of test results for donor samples and components into the ElDorado Donor database. The Test Result Interface is intended to receive, parse, validate, and translate testresults from testing analyzers or facilities BK090063 Wyndgate Technologies
4925 Robert J. Matthews Parkway
Suite 100
El Dorado Hills, CA 95762
11/20/2009
ADVIA Centaur HIV 1/O/2
Enhanced ReadyPack Reagents
An in vitro diagnostic immunoassay 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. BP050030/008 Siemens Medical Solutions
Diagnostics
511 Benedict Ave.
Tarrytown, NY 10591
11/19/2009
ADVIA Centaur HIV 1/O/2
Enhanced ReadyPack
Reagents
An automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens.The system menu includes endocrine, anemia, allergy, reproductive, cardiovascular,
  • Oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. 
Allassays are based on chemiluminescent technology.
BP050030/010 Siemens Medical Solutions
Diagnostics
511 Benedict Ave.
Tarrytown, NY 10591
11/13/2009
Sunrise Blood Bank version2.0 SP2 Blood Establishment Software BK090044 Eclypsis Corporation
450 Lapp Road
Malvern, PA 19355
11/13/2009
Platelet PGD Test System Bacterial Detection Systems
for Platelet Transfusion
Products
BK090028 Verax Biomedical Incorporated
377 Plantation St., Biotech 4
Worcester, MA 01605
11/10/2009
ElDorodo Donor Doc Blood Establishment Software BK090033 Wyndgate Technologies
4925 Robert J. Matthews
Parkway
Suite 100
El Dorado Hills, CA 95762
10/28/2009
VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator and VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack HIV Detection Test BP050051/018 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester, NY 14626-5101
10/9/2009
Symphony System Blood Establishment Software BK090041 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
9/28/2009

My Cells Autologous Platelet Preparation Kit

To be used in the clinical laboratory or intra-operatively at point-of-care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood BK080057 Kaylight Corporation
602 Anacapa
Irvine, CA 92602
9/25/2009
Avioq HIV-1 Microelisa System HIV Detection Test BP090022 Avioq, Inc.
9700 Great Seneca Hwy.
Rockville, MD 20850
9/21/2009
Olerup SSP HLA Typing Kits Qualitative in vitro diagnostic kits for the DNA typing Class I and Clas II HLA Allelles BK090042 Olerup SSP AB
Hasselstigen 1
SE 133 33 Saltsjobaden
Sweden
9/11/2009
Sysmex XE-2100D and XS-1000i Automated Hematology Analyzers intended for in vitro diagnostic use in clinical laboratories as multi-parameter hematology analyzers using EDTA anticoagulant and in blood centers using anticoagulants (CPD, CPD2, ACD-A, CDPA-1) commonly used in non-whole blood products for red blood cells and platelets. BK080067

Sysmex America, Inc.
One Nelson C. White Parkway
Mundelein, IL 60060

9/8/2009
Safe Trace Tx Blood Establishment Computer Software

BK090026

 

Wyndgate Technologies
4925 Robert J. Matthews
Parkway
Suite 100
El Dorado Hills, CA 95762

 

9/3/2009
Donor Information System (DIS) version 4.0 Blood Establishment Computer Software BK090001 BioLife Plasma Services LP 
One Baxter Pkwy
Deerfield, IL 60015
8/18/2009
Bone Marrow Collection Kit and Accessories Used for collection and filtration of aspirated bone marrow in preparation for bone marrow transplantation. BK090031 Fenwal Inc
Three Corporate Drive
2nd Floor
Lake Zurich, IL 60047
7/23/2009
Biomixer BM330 with XBee (Wireless) Option For use by a trained medical professional for blood collection and data registration. BK090010 Ljungberg & Kogel
C/O Kamm & Associates
333 Milford Rd.
Deerfield, IL 60015
7/17/2009
Control Cells Used for quality control of the antiglobulin test performed with Anti-Human Globulin containing ani-IgG. BK090021 American Red Cross
Diagnostic Manufacturing Division
2025 E St. NW
Washington, DC 20006
6/24/2009
SoftBank II Version 25 - 25

Blood Establishment Computer Software

BK090017 SCC Soft Computer
5400 Tech Data Drive
Clearwater, FL 33760
6/23/2009
Donor-ID Web 3.1.4

Blood Establishment

Computer Software

BK080044 Healthcare-ID
1635 Barclay Blvd.
Buffalo Grove, IL 60089
6/10/2009
AutoFusion v3.02

Blood Establishment Computer Software

BK080047 SofTov Ltd
32 HaShacham St.  49517
Petach Tikva,   Israel
6/5/2009
LIFECODES Evolution Software, version 1.0

An accessory for the evaluation of test results from

Tepnel Lifecodes' antibody screening products.

BK090018 Tepnel Lifecodes Corporation
550 West Avenue
Stamford, CT 06902
6/4/2009
ORTHO ProVue, version 3.1 A modular, microprocessor-controlled instrument designed to automate in vitro immuno-hematological testing of human blood utilizing the ID-MTS/Gel Technology. As a standalone instrument or interfaced to the customer's Laboratory Information System (LIS), ProVue automates test processing functions and data management requirements using gel cards and digital image.

BK090013

 

Micro Typing Systems Inc.
1295 S.W. 29th Ave.
Pompano Beach, FL 33069
6/4/2009
Ortho Summit System Pipetting of Enzyme linked immunosorbent assays (ELISA), including licensed blood screening tests distributed by OCD. BK090074 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
5/27/2009
Morgan HLA SSP ABCDRDQ Typing Kit An in vitro diagnostic medical device, intended for providing the HLA-A, B, C, DRB and DQB typing results with a low to medium resolution by DNA based method. BK080039 Texas BioGene, Inc.
635 Presidential Dr
Richardson, TX  75081
4/22/2009
Lifecodes LifeScreen Deluxe A qualitative test that can be used to detect the presence of IgG antibodies produced in patients sensitized to HLA by transfusion, pregnancy, or tissue transplantation. This kit is intended for in vitro diagnostics (IVD) use. BK090002 Genetic Testing Institute, Inc. (GTI)
20925 Crossroads Circle Suite 200
Waukesha, WI 53186
4/17/2009
LABScreen Multi DBA Used for the detection of antibodies to human leukocyte antigens BK080071 One Lambda, Inc.
21001 Kittridge St.
Canoga Park , CA 91303
4/10/2009
FETALSCREEN™ II

A qualitative screening test for RhD 

(Rho) positive fetal red blood cells in the maternal circulation

BK080051 Alba Bioscience
21 Ellen's Glen Road
Liberton, Edinburgh
EH17 7QT
Scotland , UNITED KINGDOM
4/8/2009
Sunquest Blood Bank Donor 6.4 Provides a complete transfusion service with autologous/ directed capabilities and inventory control. A permanent patient file allows for automatic retrieval of patient records, and applicable reports can be generated along with automatic capture of workload statistics. Billing information can be sent automatically to the hospital financial system BK080042 Sunquest Information Systems Inc.
250 S. Williams Blvd.
Tucson , AZ 85711
3/3/2009
Pall Acrodose PL System
To be used to pool and store whole-blood-derived, Leukocyte-reduced platelets in the CLX HP BK090007 Medsep Corporation
1630 Industrial Park
Covina, CA 91722
2/25/2009
MCS+8150 System - Wireless The MCS+ 8150 with wireless capable modification may be used to collect the following blood components from allogeneic and autologous donors BK090004 Haemonetics Corporation
400 Wood Road
Braintree MA 02184 -9144
2/20/2009
Olerup SSP HLA Typing Kits Qualitative in vitro diagnostic kits for the DNA typing of Class I and II HLA alleles. The products are used by trained professionals in medical settings for the purpose of determining HLA phenotype. The source material tested is DNA BK080022 Olerup SSP AB
Hasselstigen 1
SE 133 33
Saltsjobaden Sweden
2/20/2009
Pall eBDS For use with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms for quality control testing of apheresis and single and pooled units of whole-blood-derived platelet products. BK080014 Pall Life Sciences
25 Harbor Park Dr North
Port Washington , NY 11050-4630
2/13/2009
Automated Blood Bank Analyzer The Galileo is microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. BK080070 Immucor, Inc.
3130 Gateway Drive
Norcross , GA 30091-5625
2/5/2009
SoftDonor 4.5 Intended to be a decision support system used by knowledgeable users to document steps in the manufacture of blood and blood components. The software also maintains that data which blood center personnel use in making decisions regarding the suitability/deferral of donors and the release of blood or blood for transfusion purposes or for further manufacture BK080069 SCC Soft Computer
5400 Tech Data Drive
Clearwater , FL 33760
1/16/2009
TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System The TRUGENE HIV-1 Genotyping Kit and the OpenGene DNA Sequencing System is indicated for use in detecting HIV genomic mutations in the protease and part of the reverse transcriptase regions of HIV that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. BK080073 Siemens Medical Solutions Diagnostics
P.O. Box 2466
Berkeley , CA 94702-0466
1/15/2009
Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells Indicated for the leukoreduction of a single unit of AS-1 and AS-3 red cells, at room temperature (20 to 24°C) within 8 hours of collection, or AS-1, AS-3, and AS-5 red cells at 1 to 6° C up to 3 days after collection . BK080060 MacoProductions S.A.S.
1733 Canton Lane, Suite 103
Marietta , GA 30062-2679
1/14/2009