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.

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Tradename	Description and Indication for Device	Submission ID	Manufacturer	Clearance Date
LABType (R) SSO DNA Typing Tests for use with LABScanTM 3D	For the DNA typing of HLA CLASS I OR II ALLELES.	BK120024	One Lambda, Inc 21001 Kittridge St Canoga Park, CA 91303	12/20/2012
DPP HIV 1/2 Assay	A 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.	BP120032	Chembio Diagnostic Systems, Inc. 3661 Horseblock Road Medford, NY 11763	12/19/2012
Donor Information System (DIS) v 6.0	Blood Establishment Software	BK120064	BioLife 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.	BK120047	Fenwal, Inc. Three Corporate Drive Lake Zurich, IL 60047	12/18/2012
HLA Fusion Software, Version 3.0	Blood Establishment Software	BK120014	One Lambda, Inc 18-DEC-12 21001 Kittridge St Canoga Park, CA 91303	12/18/2012
Picture-ID Version 2.0	Blood Establishment Software	BK120035	Calimex USA Corporation 258 Hollister Avenu Alameda, CA 94501	12/17/2012
Trima Accel System	Intended 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-rWBC	Intended for in vitro use for the enumeration of residual white blood cells in leukoreduced blood products.	BK120068	Nanoentek, Inc. 300 Washington St., STE 416 Newton, MA 02458	12/5/2012
PCS2 Plasma Collection System	The 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.	BK120065	Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114	11/26/2012
LIFECODES HLA-C eRES Typing Kit for use with Lumine	Qualitative 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.	BK120063	Gen-Probe 550 West Avenue Stanford, CT 06902	11/21/2012
DiaSpect Control HBT (-L, -M.-H	Used 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.	BK120052	Diaspect 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 Screen	Qualitative 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 Cells	Used to confirm reactivity of the anti C3 component of an anti globulin reagent.	BK120022	Hemo 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.	BK120042	American 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.	BK120040	Terumo 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.	BK120041	Fenwal, 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.	BK120038	Harvest Technologies 40 Grissom Road Plymouth, MA 02360	9/28/2012
HCLL (TM) Transfusion 2012	Blood Establishment Software	BK120036	Mediware 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.	BK110071	Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921	9/12/2012
DoVac Elite 1.0	Blood Establishment Software	BK110064	IT Synergistics, LLC 115 Tree Street Flowood, MS  39232	9/6/2012
LifeTrak(R) 2012	Blood Establishment Software	BK120039	Mediware 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.	BK110012	Fresenius 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.	BK120009	Cascade 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.	BK120008	Cascade Medical Enterprises, LLC 20 Greenup Court Wayne, NJ 07470	8/1/2012
ADAM-rWBC	For in vitro diagnostic use for the enumeration of residual leukocytes in leukoreduced blood products.	BK120015	Nanoentek, 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.	BK120018	Fenwal, Inc. Three Corporate Drive Lake Zurich, IL 60047	7/20/2012
Spectra Optia Apheresis System	Mononuclear Cell (MNC) Collection (Automated Blood Cell Separators).	BK120012	TERUMO 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 System	Intended 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.	BK120026	MEDSEP Corporation 1630 Industrial Park St Covina, CA 91722	6/29/2012
Donor-ID Web (TM) 3.2	Blood Establishment Software	BK120030	Healthcare-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	BK120028	Blood Bank Computer Systems, Inc. 1002 15th St. SW, Suite 120 Auburn, WA 98001-6502	6/21/2012
ImmuLINK, version 2.0	Blood Establishment Software	BK120016	Immucor, 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.	BK110054	Immunetics, Inc. 27 Drydock Ave Boston, MA 02210-2377	6/11/2012
Lifecodes Class II ID v2	A 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.	BK110011	Gen-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.	BK120017	TERUMO Corporation 10811 W. Collins Ave Lakewood, CO 80215	5/31/2012
Antigen PLUS 7.4	Blood Establishment Software	BK110045	Rowny Systems, Inc. 7555 Spring Lake Dr Bethesda, MD 20817-6507	5/25/2012
FMH RapidScreen	For use in the detection of D-positive red blood cells in D-negative mothers.	BK110067	Immucor, Inc. 3130 Gateway Drive P.O. Box 5625 Norcross, GA 30091-5625	5/22/2012
RegenKit-BCT Family Kits	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 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.	BK110061	RegenLab SARL En Budron B2 CH-1052 Le Mont sur Lausanne, Switzerland	5/8/2012
LOGIC version 3.0.0	Blood Establishment Software	BK120002	Haemonetics 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.	BK110072	Fenwal 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.	BK110035	Estar 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.	BK120013	Siemens Healthcare Diagnostics Inc. P.O. Box 2466 Berkeley, CA 94702	3/27/2012
Trima Accel Automated Blood Component Collection System	Automated Blood Cell Separators	BK110068	CaridianBCT 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.	BK120006	Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202 P.O. Box 350 Raritan, NJ 08869-0606	3/15/2012
Product Sample Pack	The Product Sample Pack is an empty container for the processing of blood and blood components.	BK110066	Fenwal Inc Three Corporate Dr Lake Zurich, IL 60047	2/27/2012
eOrders, Version 1.1	Blood Establishment Software	BK110070	Calimex 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.	BP050069/039	Roche Molecular Systems, Inc. 4300 Hacienda Drive P.O. Box 9002 Pleasanton, CA 94588-0900	2/3/2012
Regulated Software Application (RSA) 1.0	Blood Establishment Software	BK110048	Community Blood Centers of South Florida 1700 North State Road 7 Lauderhill, FL 33313	1/12/2012
MediCopia Transfusion v4.1	Blood Establishment Software	BK110055	Lattice, Inc. 1751 South Naperville Rd Suite 100 Wheaton, IL 60189	1/6/2012