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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2012 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.


TradenameDescription and Indication for DeviceSubmission IDManufacturerClearance Date
LABType (R) SSO DNA Typing Tests for use with LABScanTM 3DFor the DNA typing of HLA CLASS I OR II ALLELES.BK120024One Lambda, Inc
21001 Kittridge St
Canoga Park, CA 91303
12/20/2012
DPP HIV 1/2 AssayA single-use immuno- chromatographic, rapid screening test for the detection of antibodies to Human Immuno- deficiency Virus Types 1 and 2 (HIV 1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio HIV 1/2 Assay is intended for use as a point of care test to aid in the diagnosis of infection with HIV 1 and HIV 2. This test is suitable for use in a multi-test algorithms designed for the statistical
validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms.
 
BP120032Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford, NY 11763
12/19/2012
Donor Information System (DIS) v 6.0
 
Blood Establishment Software
 
BK120064BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015
12/19/2012
Autopheresis-C Plasmapheresis System Plasmacell-C Set
 
An automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration. Plasma intended for transfusion must be transfused or processed as fresh frozen plasma within eight hours of venipuncture or in accordance with local regulatory requirements.  Collected plasma may also be processed as Source Plasma.
 
BK120047Fenwal, Inc.
Three Corporate Drive
Lake Zurich, IL 60047
 
12/18/2012
HLA Fusion Software, Version 3.0
 
Blood Establishment Software
 
BK120014One Lambda, Inc 18-DEC-12
21001 Kittridge St
Canoga Park, CA 91303
12/18/2012
Picture-ID Version 2.0
 
Blood Establishment Software
 
BK120035Calimex USA Corporation
258 Hollister Avenu
Alameda, CA 94501
12/17/2012
Trima Accel SystemIntended for use in collecting blood components for later transfusion into patients.
 
BK120049
 
TERUMO Corporation
10811 W. Collins Avenue
Lakewood, CO 80215
12/17/2012
ADAM-rWBCIntended for in vitro use for the enumeration of residual white blood cells in leukoreduced blood products.
 
BK120068Nanoentek, Inc.
300 Washington St., STE 416
Newton, MA 02458
12/5/2012
PCS2 Plasma Collection SystemThe LN625HS and LN625B are disposable centrifuge bowls designed for use with the PCS2 LN6002 and the LN620 disposable harness for the collection of source plasma and plasma for reinfusion, with or without saline compensation.
 
BK120065Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
11/26/2012
LIFECODES HLA-C eRES Typing Kit for use with LumineQualitative tests for the DNA typing of Class I and Class II HLA alleles. Used by trained professionals in medical settings for the purpose of determining HLA phenotype. The source 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; across-match is routinely required.
 
BK120063Gen-Probe
550 West Avenue
Stanford, CT 06902
11/21/2012
DiaSpect Control HBT (-L, -M.-HUsed by professionals in the verification of the precision and accuracy of the DiaSpect Hemoglobin T analyzer and DiaSpect Hemoglobin Cuvettes. For In Vitro diagnostic use only.
 
BK120052Diaspect Medical GMBH
800 E. Leigh Street
Suite 206-5
Richmond, VA 23219
11/14/2012
Patient Touch(TM) Blood Product Administration System v3.2.1
 
Blood Establishment Software
 
BK120029
 
PatientSafe Solutions
5375 Mira Sorrento Place
Suite 500
San Diego, CA 92121
11/13/2012
TPHA ScreenQualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passable hemag-glutination using the Galilea and/or Galileo Neo Automated Blood Bank Systems.
 
BK120021
 
Immucor, Inc.
3130 Gateway Drive
P.O. Box 5625
Norcross, GA 30091-5625
10/24/2012
C3 Control CellsUsed to confirm reactivity of the anti C3 component of an anti globulin reagent.BK120022Hemo bioscience
801 Capitola Drive Suite 9 Research Triangle Park Durham, NC 27713
10/24/2012

Instrument Manager v8.12

Blood Establishment Software

BK120051

Data Innovations Inc. 
120 Kimball Ave, Suite 100
South Burlington, VT  05430

10/17/2012

DailyChek QC Kit

Used in quality control of blood bank reagent red blood cells. 

BK120042American National Red Cross
Diagnostic Manufacturing Division
9319 Gaither Road
Gaithersburg, MD 20877
10/6/2012
 

Trima Accel® System

An automated blood cell separator intended for use in collecting blood components for later transfusion into patients.

BK120040Terumo BCT, Inc.
10811 West Collins Avenue
Lakewood, CO 80215
10/3/2012

AMICUS Separator System; ALYX Component System

An automated blood cell separator indicated for the collection of blood components and mononuclear cells. The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.BK120041Fenwal, Inc.
Three Corporate Drive
Lake Zurich, IL 60047
10/3/2012
Harvest PRP Separation System with ACDA (30mL)Designed to be used 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 or allograft bone prior to the application of an orthopedic surgical site as deemed necessary by the clinical use requirements.
 
BK120038Harvest Technologies
40 Grissom Road
Plymouth, MA 02360
 
9/28/2012
HCLL (TM) Transfusion 2012Blood Establishment SoftwareBK120036Mediware Information Systems, Inc.
1900 Spring Rd
Suite 450
Oak Brook Service Ctr
Oak Brook, IL 60523 
9/19/2012
TSCD (R) II Sterile Tubing Welder & Trucise Total System
(R)
Used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components.BK110071Terumo Medical Corporation
950 Elkton Blvd
Elkton, MD 21921
9/12/2012
DoVac Elite 1.0Blood Establishment SoftwareBK110064
IT Synergistics, LLC
115 Tree Street
Flowood, MS  39232
9/6/2012
LifeTrak(R) 2012Blood Establishment SoftwareBK120039Mediware Information Systems, Inc.
1900 Spring Rd
Suite 450
Oak Brook Service Ctr
Oak Brook, IL 60523
9/5/2012
CompoMat G5 and
CompoMaster Net G5 System
CompoMat G5 and CompoMaster Net G5 System is intended for the automatic and reproducible raparatin of centrifuged whole blood and blood
components.
BK110012Fresenius Kabi, LLC
1501E. Woodfield Rd
Schaumburg, IL 60173
8/2/2012
FIBRINET (R) Autologous PRP
System
Designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma
(PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to
application to a bony defect for improving handling
characteristics.
BK120009Cascade Medical Enterprises, LLC
20 Greenup Court
Wayne, NJ 07470
8/1/2012
FIBRINET (R) Autologous PRP
System
Designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma
(PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to
application to a bony defect for improving handling
characteristics.
BK120008Cascade Medical Enterprises, LLC
20 Greenup Court
Wayne, NJ 07470
8/1/2012
ADAM-rWBCFor in vitro diagnostic use for the enumeration of residual leukocytes in leukoreduced blood products. 
 
BK120015Nanoentek, Inc.
300 Washington St., STE 416
Newton, MA 02458
7/24/2012
AMICUS Apheresis Kits
AMICUS Separator System
 
For the collection of blood components and mononuclear cells.BK120018Fenwal, Inc.
Three Corporate Drive
Lake Zurich, IL 60047
7/20/2012
Spectra Optia Apheresis SystemMononuclear Cell (MNC) Collection (Automated Blood Cell Separators).BK120012TERUMO Corporation
10810 W. Collins Ave
Lakewood, CO 80215
7/9/2012
OraQuick® In-Home HIV Test
 
A Multi-Center, Actual Use Clinical Trial of the OraQuick ADVANCE HIV 1/2 Antibody Test Over-the-Counter (OTC) Product Performance in Untrained Users. 
 
BP120001 
 
OraSure Technologies, Inc.
220 East First Street
Bethlehem, PA 18015-1360
7/3/2012
Pall Celeris fPC SystemIntended for the rapid preparation of autologous platelet concentrate (PC) from a small sample of blood at the patient's point of care. The PC can be mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. 
 
BK120026MEDSEP Corporation
1630 Industrial Park St
Covina, CA 91722
6/29/2012
Donor-ID Web (TM) 3.2Blood Establishment Software 
 
BK120030Healthcare-ID
1635 Barclay Blvd.
Buffalo Grove, IL 60089
6/25/2012
BBCS BloodTrack Interface Application (BBCSBT), BT1.0.0 Blood Bank Control System V. 5.0 
 
Blood Establishment Software 
 
BK120028Blood Bank Computer Systems, Inc.
1002 15th St. SW, Suite 120
Auburn, WA 98001-6502 
6/21/2012
ImmuLINK, version 2.0 Blood Establishment SoftwareBK120016Immucor, Inc.
3130 Gateway Drive
P.O. Box 5625
Norcross, GA 30091-5625 
6/14/2012
BacTx(R) Bacterial Detection
Kit for Platelets
A rapid, qualitative, colorimetric assay for the detection of aerobic
and anaerobic, Gram-positive and Gram-negative bacteria in pools of up to six (6) units of leukocyte
reduced whole blood derived platelets that are pooled within four (4) hours of transfusion as a
quality control test.
BK110054Immunetics, Inc.
27 Drydock Ave
Boston, MA 02210-2377
6/11/2012
Lifecodes Class II ID v2A qualitative immunoassay 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 diagnostic use.
 
BK110011Gen-Probe GTI Diagnostics
20925 Crossroads Circle
Waukesha, WI 53186
6/4/2012
Trima Accel Automated Blood
Component Collection System
To change the software of the Version 6 Trima Accel device to minimize the amount of air that was sent from the needle line and
re-direct air into the attached larger vent bag.
 
BK120017TERUMO Corporation
10811 W. Collins Ave
Lakewood, CO 80215
5/31/2012
Antigen PLUS 7.4Blood Establishment SoftwareBK110045Rowny Systems, Inc.
7555 Spring Lake Dr
Bethesda, MD 20817-6507
5/25/2012
FMH RapidScreenFor use in the detection of D-positive red blood cells in D-negative mothers.
 
BK110067Immucor, Inc.
3130 Gateway Drive
P.O. Box 5625
Norcross, GA 30091-5625
5/22/2012
RegenKit-BCT Family KitsDesigned to be used 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 is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. RegenKit®-BCT
Family Kits are for single use only.
BK110061RegenLab SARL
En Budron B2
CH-1052 Le Mont sur Lausanne, Switzerland
5/8/2012
LOGIC version 3.0.0Blood Establishment SoftwareBK120002Haemonetics Corporation
10025 102A Ave NW
Suite 500
Edmonton, Canada
T5J 2Z2
4/24/2012
Aurora Plasmapheresis
System
Plasmacell-C Disposable Set
Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single use disposable sets.
 
BK110072Fenwal Inc
Three Corporate Drive
Lake Zurich, IL 60047
3/29/2012
TropoCells Autologous
Platelet Preparation Kit
Intended for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care, and the PRP is mixed with autograft or allograft bone prior to application to an orthopedic surgical site.
 
BK110035Estar Technologies LTD
420 Lexington Avenue
Suite 2400
New York, NY 10170
3/28/2012
 
TRUGENE HIV-1 Genotyping
Kit and OpenGene DNA Sequencing System
For use in detecting HIV genomic mutations in the protease and part of the reverse transcriptase region of HIV that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection.
 
BK120013Siemens Healthcare
Diagnostics Inc.
P.O. Box 2466
Berkeley, CA 94702
3/27/2012
Trima Accel Automated Blood
Component Collection System
Automated Blood Cell SeparatorsBK110068CaridianBCT
10811 W. Collins Avenue
Lakewood, CO 80215-4498
3/23/2012
ORTHO VERSEIA Pipetter as
Part of the ORTHO Summit
System (OSS) v 3.0
Used for the pipetting of enzyme-linked immunosorbent assays (ELISA), including licensed blood screening tests distributed by Ortho-Clinical Diagnostics, Inc. The instrument aspirates and dispenses samples and reagents into microplates. The ORTHO VERSEIA® Pipetter reads identification (10) barcodes on the sample tubes, controls/calibrators, reagent containers, and microplates. For in vitro diagnostic use.
 
BK120006Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
3/15/2012
Product Sample PackThe Product Sample Pack is an empty
container for the processing of blood
and blood components.
BK110066Fenwal Inc
Three Corporate Dr
Lake Zurich, IL 60047
2/27/2012
eOrders, Version 1.1Blood Establishment SoftwareBK110070Calimex USA Corp
258 Hollister Ave.
Alameda, CA 94501
2/17/2012
COBAS AmpliPrep/COBAS
TaqMan® HIV-1 Test, version 2.0
HIV Detection Test intended to be used with
FDA (CDRH) approved products.
BP050069/039Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94588-0900
2/3/2012
Blood Establishment SoftwareBK110048Community Blood Centers of
South Florida
1700 North State Road 7
Lauderhill, FL 33313 
1/12/2012
Blood Establishment Software
 
BK110055Lattice, Inc.
1751 South Naperville Rd
Suite 100
Wheaton, IL 60189
1/6/2012