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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2013 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 DeviceSubmission IDManufacturer
 
Clearance Date

LIFECODES HLA-A SSO Typing Kit

LIFECODES HLA-A eRES SSO Typing Kit

LIFECODES HLA-B SSO Typing Kit

LIFECODES HLA-B eRES SSO Typing Kit

LIFECODES HLA-C eRES SSO Typing Kit

LIFECODES HLA-DQB SSO Typing Kit

LIFECODES HLA-DRB1 SSO Typing Kit

LIFECODES HLA-DRB1 eRES SSO Typing Kit

LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit

for use with Luminex

LIFECODES HLA SSO Typing Kits are qualitative tests (in vitro diagnostic kits) for the DNA typing of Class I and Class II HLA alleles. The products are used by trained professionals in medical settings for the purpose of determining HLA phenotype. The source of material tested is DNA. No component of the kit comes in direct contact with the patient. DNA typings are not the sole tests upon which a clinical decision affecting the patient is based; a cross-match is routinely required. These kits are intended for In Vitro Diagnostic (IVD) use.
 
BK130075/0Immucor Transplant Diagnostics, Inc.
550 West Avenue Stamford CT
06902
12/24/13

Biofortuna Ltd. SSPGo HLA Typing Kit
Qualitative Test for HLA, Non-diagnostic

Biofortuna SSPGo HLA Typing Kits are intended as a method of genotyping DNA from blood. The SSPGo HLA Typing Kits are qualitative DNA-based kits for determining HLA alleles in low to intermediate resolution.
 

BK130028/0

Biofortuna LTD
1 Hawkshead Road
Croft Business Park
Wirral
Merseyride UK CH623RJ

12/19/13

MLB 2 10 x 10 mL /Potentiating Media for in vitro Diagnostic Use
 
MLB 2 is used for the tube test as potentiator for red blood cells applied in the indirect antiglobulin test (IAT) for crossmatch, antibody screening and -identification, as well as antigen typing with coombsreactive Blood Grouping Reagents.
 
BK130070/0
 
Bio-Rad Medical Diagnostics GmbH
Dreieich,   GM
Industriestrasse 1
 
11/27/2013
LABScreen®
for use with LABScan(TM) 3D

/Qualitative Test for HLA, Non-diagnostic
 
For use in the detection of HLA antibody using flow cytometric technology
 
BK130009/0
 
One Lambda, Inc
21001 Kittridge St
Canoga Park, CA 91303
 
11/06/2013
 
Alyx Component Collection System (Alyx Classic) /Automated Blood Cell Separators
 
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.
 
BK130030/0Fenwall, Inc
Three Corporate Drive
Lake Zurich, IL  60047
 
11/01/2013
LIFECODES(R) LifeScreen Deluxe (LMX)
LIFECODES (R) LifeScreen Deluxe is a qualitative test that can be used to detect the presence of IgG antibodies produced in patients sensitized to HLA by transfusion, pregnancy, or tisuue transplantation. This kit is intended for In Vitro  Diagnostic (IVD) use.
 
BK130046
 
Immucor GTI Diagnostics, Inc.
20925 Crossroads Circle
Waukesha, WI 53186
 
09/23/2013
 
Alyx Component Collection System
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.
 
BK130004
 
Fenwal Inc
Three Corporate Dr
Lake Zurich, IL 60047
09/13/2013
ViroSeq® HIV-1 Genotyping System v2.0
 
Use in detecting HIV genomic mutations that confer resistance to specific types of Antiretroviral drugs as an aid in monitoring and treating HIV infection.
 
BK130039
 
Celera Corporation
1401 Harbor Bay Parkway
Alameda, CA 94502 US
09/05/2013
WADiana(R) Compact
Automated Blood Grouping and Antibody Test Systems
 
WSDiana(R) Compact is a fully automated analyzer designed to automate in vitro immunuhematoligical testing of human blood utilizing the DG Gel(R) 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), it automates test processing functions and data management requiremnets using DG Gel(R) 8 cards and digital image processing.
 
BK130025
 
Diagnostic Grifols, S.A.
Passeig Fluvial, 24
Barcelona
Parets Del Valles, SP
 
8/30/2013
 
BacTx Reader
BacTx Software
BacTx® Bacterial Detection Kit
for Detection of Bacteria in
Platelets

Bacterial Detection Systems for Platelet Transfusion Products
 
The Immunetics BacTx® Bacterial Detection Kit for detection of bacteria in platelets is a rapid, qualitative, colorimetric, quality control test for the detection of aerobic and anaerobic, Gram positive and Gram-negative bacteria in leukocyte reduced apheresis platelet units and pools of up to six (6) units of leukocyte reduced whole blood-derived platelets (Platelets, Leukocytes Reduced) that are pooled within four (4) hours of transfusion.
 
BK130017
 
Immunetics, Inc.
27 Drydock Avenue
Boston, MA 02210-2377
 
8/12/2013
 
ORTHO (TM) Workstation
Automated Cell-Washing Centrifuges for Immunohematology
 
The ORTHO (TM) Workstation is intended to support the in vitro immunohematology testing of human blood through the incubation and centrifugation of ID- MTS(TM) Gel cards.
 
BK130032Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ  08869-0606
 
08/09/2013
Spectra Optia Apheresis System
 
Mononuclear (MNC) Collection
 
BK130031
 
TERUMO BCT
10811 W. Collins Ave
Lakewood, CO 80215-4440
 
7/25/2013
 
DG Gel 8 Neutral Gel
The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens in human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
 
BK120043
 
Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Barcelona
Parets Del Valles, SP
7/19/2013
 
Grifols Diluent
Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards. For in vitro diagnostic use.
 
BK120044
 
Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Barcelona
Parets Del Valles, SP
 
7/19/2013
 
DG Spin
DG SPIN Centrifuge is a device specifically designed to centrifuge DG Gel 8 Cards. For in vitro diagnostic use only.
 
BK120045
 
Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Barcelona
Parets Del Valles, SP
 
7/19/2013
 
DG THERM
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37 ºC for immunohematology applications.
 
BK120046
 
Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Barcelona
Parets Del Valles, SP
 

7/19/2013

 

SynGenX-1000
The SynGenX-1000 Platform is a cord blood processing system intended for laboratory use in combination with specific and compatible single-use separation and cryopreservation kits supplied by SynGen, Inc. The SynGenX-1000 Platform allows the fast, automated, and reproducible separation and cryopreservation of cord blood in a closed and sterile environment.
 
BK120061
 
SynGen, Inc
2125 19th Street, Suite 120
Sacramento, CA 95818
 
7/12/2013
 
Automated Plasma
Dispositioning System (APDS)
v1.0
The Automated Plasma Dispositioning System (APDS) is used to receive, analyze, and store data for human plasma collected and shipped between facilities such as collection sites, warehouses and fractionation facilities.
 
BK120069
 
BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015
 

5/31/2013

 

iTrace for Blood Centers 1.0.924.0
 
iTrace is intended to be used by trained personnel to streamline supply chain processes and aid in product tracking and  reconciliation in blood center operations.
 
BK120067
 
SysLogic, Inc.
375 Bishops Way, Suite 105
Brookfield, WI 53005
 
5/28/2013
 
ORTHO VERSEIA® Integrated Processor (VIP)
Modification of the ORTHO VERSEIA Pipetter platform to include a fully automated system to the ortho Summit System (OSS).
 
BK130006
 
Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202 P.O. Box 350
Raritan, NJ 08869-0606
5/23/2013
ABBOTT PRISM Director
Software, Blood Virus Application
 
BK130020Abbott Laboratories
Dept 09VA, Bldg AP8-1
100 Abbott Park Road
Abbott Park, IL 60064-3500
5/14/2013
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, v2.0 
 
Blood Establishment Software 
 
BP050069/055 
 
Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94588-0900 
 
5/7/2013
 
Phlebotomy System 
 

Blood Establishment Software 

 

BK120084 
 
Haemonetics Corporation
4925 Robert J Mathews
Parkway suite 100
El dorado Hills, CA 95762
 
4/30/2013
Multispot HIV-1/HIV-2 Rapid Test
 
Modification to the package insert for the Multispot HIV-1/HIV-2 Rapid Test so that it can be used in conjunction with the HIV diagnostic testing algorithm that is being recommended be the CDC in the near future 
 
BP040046/015
 
Bio-Rad Laboratories
6565 185th Avenue NE
Redmond, WA 98052 
 
3/25/2013
MCS+8150 System - Wireless 
 
The purpose is to expand the indications for use to include a filtered Red Blood Cell and plasma protocol, 822F-2. 
 
BK120083
 
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
 
3/20/2013
Spectra Optia Apheresis System 
 
Mononuclear Cell (MNC) Collection
 
BK120076TERUMO BCT
10811 W. Collins Ave
Lakewood, CO 80215-4440 
 
2/25/2013
 
Leucolab LCG2 Leukoreduction Systems for AS-1 Red Blood Cells Leucolab LCG2 Leukoreduction Systems for AS-1 and AS-3 Red Blood Cells Leucolab LCG2 Leukoreduction Systems for AS-1, AS-3 and AS-5 Red Blood Cells 
 
The Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AD-5 Red Blood Cells is indicated for the leukoreduction of a single unit of AS-1, AS-3 and AS-5 red cells at 1 to 6 degrees C up to 3 days after collection. The storage period for the Leukoreduced Red Blood Cells is determined by the anticoagulant or preservative used in their manufacture. 
 
BK120071MacoProductions S.A.S.
3675 Crestwood Parkway Suite 260
Duluth, GA 30096
2/22/2013
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, v2.0 and COBAS® TaqMan® HIV-1 Test, version 2.0 For Use With The High Pure System 
 
Blood Establishment Software 
 
BP050069/053 Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94588-0900
2/19/2013
 
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, v2.0
 
Blood Establishment Software
 
BP050069/052 Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94588-0900 
 
2/14/2013
SeCore HLA Sequencing
System /
uType Dx HLA Analysis
Software v 1.0
 
Blood Establishment Software
 
BK110038Life Technologies Corporation
9099 North Deerbrook Trail
Brown Deer, WI 53223 
2/5/2013
3500 Dx/3500 xL Dx Genetic Analyzer 8 CS2 and 3500 Dx
Series Software
 
Blood Establishment Software 
 
BK110039Life Technologies Corporation
9099 North Deerbrook Trail
Brown Deer, WI 53223
2/5/2013
Uni-Gold Recombigen® HIV 

HIV Detection Test 

BP030025/019

Trinity Biotech
2823 Girts Road
Jamestown, NY 14702-1059

2/4/2013
Intra-Spin System Intended for the safe and rapid preparation of
autologous platelet rich fibrin (PRF) from a small sample of blood at the patient's point of care.
The PRF is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
 
BK120048Intra-Lock International
6560 West Rogers Circle
Boca Raton, FL 33487
 
1/28/2013
AMICUS Apheresis Kits / AMICUS Separator SystemAn automated blood cell separator indicated for the collection of blood components and mononuclear cells.
 
BK120082Fenwal Inc
Three Corporate Dr
2nd Floor
Lake Zurich, IL 60047
1/8/2013