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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2010 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
ALYX Component Collection SystemFor use in blood collection establishments to collect and separate whole blood into its componentsBK100056Fenwal Inc
Three Corporate Dr
2nd Floor
Lake Zurich, IL 60047
12/7/2010
Cell-Freeze® Cryogenic
Storage Container
For the storage, preservation and transfer of hematopoietic progenitor cells (HPC) in liquid nitrogen to 196°C. The Cell-Freeze® Cryogenic Storage Container is provided sterile (fluid path) and intended for single use.BK100049Charter Medical, Ltd.
3948-A Westpoint Blvd.
Winston-Salem, NC 27103
12/7/2010
INSTI™ HIV-1 Antibody Test KitRapid testing for Human Immuno-deficiency Virus type-1 infection which is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to HIV-1 in human whole blood, finger stick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV-1 infectionsBP090032bioLytical Laboratories, Inc
1108-13351 Commerce Pkwy Richmond, BC, Canada
11/29/2010
Autopheresis-C
Plasmapheresis System
To collect virtually cell-free plasma by membrane filtration. Plasma intended for transfusionBK100050Fenwal Inc
Three Corporate Drive
2nd Floor
Lake Zurich, IL 60047
11/16/2010
 
LifeTrak/Lab and Distribution
4.6.0
Blood Establishment SoftwareBK100057Mediware Information Systems, Inc.
11711 West 79th St
Lenexa, KS 66214
11/16/2010
ORTHO  VERSEIA™ Pipetter as
part of the ORTHO Summit™ System
A modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local are network, assay-specific pipetting protocols and Ortho Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with enzyme-linked immunosorbent assay microplate testing. BK100061Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
10/28/2010
LifeTrak/Donor 4.6.0Blood Establishment SoftwareBK100043Mediware Information Systems, Inc.
11711 West 79th St
Lenexa, KS 66214
10/21/2010
SGP Version 7.0 (Plasma
Management System)
Blood Establishment SoftwareBK090082Biomat USA, Inc.
1311 Temple Ave
City of Industry, CA 91746
10/1/2010
RC-AIDAn electronic aid to trained blood transfusion service technologies for use in the identification and ruling out of antibodies to human red blood cell antigens from antibody test systems.  RC-AID is updated with the red cells in the inventory and it assists technologists in quickly choosing the best cells to complete the identification. RC-AID searches the cells in the inventory for specific cells that have the antigens that will complete the identification. BK100037BBK Technology LLC
2910 E Highland Ave
Phoenix, AZ 85016
9/13/2010
ALBAcyte IgG
Sensitized Red Blood Cells
Intended for use as a control of the anti-human globulin test.BK100005ALBA Bioscience
21 Ellen's Glen Rd
Liberton, Edinburgh
EH17 7QT
Scotland, United Kingdom
8/26/2010
Galileo NeoA microprocessor-controlled instrument designed to fully automate immuno-hematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO 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, red blood cell phenotyping, antigen screening and infectious disease screening such as cytomegalovirus (CMV). BK100033Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30091-5625
8/23/2010
Instrument Manager 8.10.01Blood Establishment SoftwareBK100046Data Innovations Inc.
120 Kimball Ave. Suite 100
South Burlington, VT 05430
8/12/2010
Trima Accel System Version 6.0Automated Blood Cell Separator intended for use in collecting blood components for later transfusion into patientsBK100032CaridianBCT
10811 W. Collins Avenue Lakewood, CO  80215-4498
8/6/2010
Autopheresis - C Plasmapheresis SystemTo collect virtually cell-free plasma by membrane filtration.BK100041Fenwal Inc
Three Corporate Drive
2nd Floor
Lake Zurich, IL 60047
8/5/2010
Lab 21 TPHA OC KitFor the qualitative detection of IgG and IgM antibodies to Treponema palladium in human serum and plasma by passive hemagglutination on the Olympus PK7200/PK7300
Analyzer.  The design and characteristics of the test make it well suited for the screening of blood donors.
BK100024Lab 21 Healthcare Ltd
184 Cambridge Science Park
Cambridge
CB4 0GA
United Kingdom
8/3/2010
Amicus Separator SystemFor collection of blood components and mononuclear cells.  The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post-platelet count greater than or equal to 100,000 platelets/uL.BK100044Fenwal Blood Technologies
Three Corporate Drive
Lake Zurich, IL 60047
7/30/2010
SoftBank II 25.1Blood Establishment Software BK100045SCC Soft Computer
5400 Tech Data Drive
Clearwater, FL 33760
7/29/2010
VITROS Immunodiagnostics
Products Anti-HIV 1+2 Controls

For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immuno- diagnostic System and the VITROS 5600 Integrated System when used for the qualitative in vitro detection of antibodies to HIV types I and or/2 (anti HIV 1 and anti-HIV-2) in human serum and plasma (Heparin, EDTA, or citrate) when using the VITROS Immuno-diagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immuno-diagnostic Systems, the VITROS 3600 Immonodiagnostic System, the VITROS 5600 Integrated System.

 

BK100040Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626-5101
7/22/2010
Autologous
Platelet Concentrator
(APC)(TM) System
For the rapid preparation of autologous platelet rich plasma/platelet poor plasma from a small sample of blood at the patient's point of care. The platelet rich plasma/platelet poor plasma is mixed with autograft and/or allograft prior to application to a bony defect for improving handling characteristics.BK100014Circle Biologic, LLC
3650 Annapolis Lane, Suite 105
Minneapolis, MN 55447
7/9/2010
 
GalileoA microprocessor-controlled instrument designed to fully automate immuno- hematology in vitro diagnostic testing of human blood. Automates test processing, result interpretation and data management functions.  BK090057Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30091-5625
7/9/2010
Sanguin Liberty SRIMPORTBlood Establishment Software BK100030 Sanguin International
1020 Sherman Avenue
Hamden, CT 06514
7/8/2010
Donor Information System (DIS)    Blood Establishment Software BK100021
 
BioLife Plasma Services LP
One Baxter Parkway
Deerfield, IL 60015 
6/18/2010
ALBAcheck - BGS Whole Blood Controls -SP  Intended for use as ABO and RhD controls for automated blood grouping systems and is also suitable for antibody screening controls.  
BK090030
 
ALBA Bioscience
21 Ellen's Glen Rd
Liberton, Edinburgh
EH17 7QT
Scotland,
UK 
6/14/2010

Horizon MobileCare Transfusion

 

Blood Establishment SoftwareBK090051

McKesson Provider Technologies
5995 Windward Pkwy
Alpharetta, GA 30005

5/28/2010
Trima Accel Automated Blood Component Collection SystemTrima Accel System is an automated blood cell separator intended for use in collection of blood components for later transfusion into patients.BK080029Gambro BCT, Inc
10811 W. Collins
Ave.
Lakewood, CO
80215-4498
5/18/2010

RegenKit-THT

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 an orthopedic surgical site as deemed necessary by the clinical use requirements.  RegenKit-THT is for single use only.

BK090048

RegenLab SARL
3428 Avenue Marcil
Montreal,  Canada

5/18/2010
ABORhCard

A qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO blood group and Rh factor status. It is not for use in blood bank processing of blood products, or for screening purposes prior to transfusion. It’s intended for single use for individual blood group determination purposes only in doctor's offices and clinic settings, and for educational and

informational purposes.

BK100008

 

Micronics
8463 154th Ave NE
Redmond, WA 98052

 

4/30/2010
Galileo Neo

A microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation

and data management functions.  Its 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, red blood cell phenotyping, antigen screening and infectious disease screening.

BK100001

Immucor, Inc.
3130 Gateway Dr
Norcross, GA 30091-5625

 

4/29/2010
SoftID.Tx Version 1.0Blood Establishment SoftwareBK090078SCC Soft Computer
5400 Tech Data Drive
Clearwater, FL 33760
4/28/2010
CryoSC Freezing BagFor single use in the storage and preservation of cord blood or its components at low and cryogenic temperature (<-150 c) in either the liquid or vapor phase of nitrogen.BK090037Biosafe SA
Route de
Petit-Eysins
Eysins, SZ
3/22/2010
HMS Blood Administration Module, Release 8.0Blood Establishment SoftwareBK090025

Healthcare Management Systems, Inc.
3102 West End Ave., 
Suite 400

Nashville, TN  37203

3/4/2010
AMICUS Separator SystemTo expand IFU for preparation of platelets to be stored with InterSol (PAS)BK090065Fenwal Inc.
Three Corporate
Drive, 2nd Floor
Lake Zurich, IL  60047
3/4/2010
Component Manufacturing Interface for ElDorado DonorTo receive, parse, validate, and translate component manufacturing information from component manufacturing equipment.BK100002Wyndgate 
Technologies
4925 Robert J.
Matthews Parkway, 
Suite 100
El Dorado Hills, CA 
95762
2/24/2010
AMICUS Separator SystemFor the simultaneous collection of platelet concentrate, plasma and red blood cells while maintaining an extracorporeal volume at or below 10.5 mL/kg and post-count greater than 100,000 platelets/mL.BK090058Fenwal Inc.
Three Corporate
Drive, 2nd Floor
Lake Zurich, IL  60047
2/18/2010
Trima Accel SystemAn automated blood cell separator intended for use in collecting blood components for later transfusion.BK090003

Caridian BCT
10811 W. Collins
Ave.
Lakewood, CO  80215-4498

 

2/16/2010
Fusionary Graft Delivery SystemTo aspirate bone marrow, autologous blood, plasma or other body fluids.BK090047Spinesmith
Partners LP
93 Red River
Austin, TX  78701
2/10/2010

Endoret Kit

 

The system is 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 allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.BK090069Biotechnology Institute, SL.
C/Leonardo Da Vinci 
4B, 1B.
01510 Minano
Alava, SP
2/01/2010

Cymbal Automated Blood Collection System

 

Intended to collect two units of RBC, Leukocytes Reduced which are collected and stored in CPD2D/AS3 from autologous and allogenic donors.

 

BK090083Haemonetics Corporation 400 Wood Road
Braintree, MA 02184-9114
1/27/2010
BBCS HospitalInterface Application (BBCSH), H 1.0.0Blood Establishment SoftwareBK090081Blood Bank Computer Systems, Inc. 1002 15th St. SW, Suite 120
Auburn, WA 98001-6502
1/20/2010
OlympusPK7300 Automated Microplate SystemA fully automated analyzer intended exclusively for agglutination technology using Olympus terraced microplatesBK090036Olympus America Inc., Diagnostic Systems Division 3500 Corporate Parkway
Center Valley, PA 18034 
1/13/2010
Blood Bank Information Management System (BBIMS V2.05.01)Blood Establishment SoftwareBK090079Duley Hopkins and Associates
1200 Mountain Creek Road # 215
Chattanooga, TN 37405
1/13/2010
CryoMACS Freezing BagFor a single cycle of freezing, storage (down to -196C), and subsequent thawing (at 37C) of human blood componentsBK090020Miltenyi Biotec, Inc.
120 Presidential Way
Suite 305
Woburn, MA 01801
1/13/2010
Picture-IDBlood Establishment SoftwareBK090054Calimex USA Corporation
258 Hollister Ave
Alameda, CA 94501
1/11/2010