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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2014 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
Centrepid Platelet Concentrator
 
Platelet And Plasma Separator For Bone Graft Handling
Rapid Preparation of PRP from small blood sample at patient's point of care
BK130079/0
Cellmedix Holdings, LLC.
19 Park Drive Franklin NJ 7416
7/31/2014

Sunquest Transfusion Manager version 2.0

Standalone Blood Bank Software

Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services.  Transfusion Manager helps users manage the following transfusion service activities:
-Positively identify transfusion recipients
-Match blood products to recipients
-Record recipient pertinent transfusion information
-Record recipient transfusion reactions and caregiver comments

BK 140124/0

Sunquest Information Systems, Inc.
205 S. Williams Blvd
Tucson AZ  85711

6/18/14
BeadCheck HEA Positive Control   BeadCheck HEA Positive ControlThe BeadCheck HEA Positive Control consists of AA and BB synthetic plasmid pools which are intended for use as assayed positive controls for the HEA BeadChip Kit. The Positive Control is designed to demonstrate that the HEA BeadChip Kit will detect all A
and B forms of each genetic marker listed. The Positive Control is not intended to monitor the DNA extraction step of the HEA BeadChip Kit.
BK130050/0BioArray Solutions, Ltd.
35 Technology Drive Warren NJ 07059
05/21/14
BioArray Imaging System (AIS) 400C   Instrumentation for Clinical Multiplex Test SystemsIt is an automated image acquisition system designed for use with BioArray Solutions BeadChips KitsBK130051/0BioArray Solutions, Ltd.
35 Technology Drive Warren NJ 07059
05/21/14
DG Reader   Manual blood grouping and antibody test systemsIt is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards.BK140101/0Diagnostic Grifols, Passeig Fluvial, 24,
Parets Del Valles,
Barcelona, SPAIN
05/21/14
Immucor PreciseType™   Human Erythrocyte Antigen Molecular BeadChip Test Molecular erythrocyte typing testPreciseType, version 1.2, is a deoxyribonucleic acid (DNA) microarray assay that utilizes polymerase chain reaction (PCR) amplification of genomic DNA coupled with an elongation mediated multiplexed analysis of polymorphisms (eMAP) platform to determine allelic variants of human erythrocyte antigens (HEA). PreciseType consists of the PreciseType assay kit, the Array Imaging System instrument, and the BioArray Information Systems Interpretive Software.BP130026/0BioArray Solutions, Ltd. 35 Technology Drive, Warren, NJ 0705905/21/14
Blood Administration Version 1800/Stand alone Blood Bank SoftwareManage all processes associated with the handling and utilization of blood units and components within the hospital.BK130003/0CPSI 6600 Wall Street Mobile AL 3669504/30/14
Procleix NAT Manager Software (Version 1.1) /Stand alone Blood Bank SoftwareProcleix NAT Manager® Software is designed to collect data from Procleix¿ assays, instruments, and pooling software, which allows operators to track individual donor samples (organ and tissue donors, including cadaveric samples) and link them to the appropriate test results. The software collates the results of pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). It is intended to be used by trained Blood Establishment and Clinical Diagnostics lab personnel01BK130052/0STRATEC Biomedical UK Limited1 Barberry Court, Callister Way04/17/14
DG Gel Extended Control /Quality Control Kits for Blood Banking ReagentsFor use in quality control with DG Gel 8 technique. DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures for:Determination of ABO, Rh, K antigens; Determination of the appropriate ABO blood group antibodiesBK140092/0Medion Grifols Diagnostics AG Bonnstrasse 9 Duedingen04/11/14
DoVac Elite v 2.0 /Stand alone Blood Bank SoftwareThe system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions. All information from a donation can be reproduced and printed to hard copy. Specific unit/product level holds generated from DoVac Elite v2.0 are displayed in the LifeTec Elite v2.0 systemBK140091/0IT Synergistics, LLC 115 Tree Street Flowood MS 3923204/09/14
Vista Information System Version 3.2/ Stand alone Blood Bank SoftwareProvide capability for the operator to identify current and new donors. Collection of data from apheresis procedures performed on Terumo BCT Trima Systems. Provide manual capability for the operator to enter procedure data for procedures performed on Terumo BCT Spectra Systems and non-Terumo BCT Systems including whole blood collections. Support for 21 CFR Part 11-compliance (Electronic Record/ Signature). Maintain a complete record of blood component donation including supplies used. Support for managing whole blood donation including use of Copper Sulphate tests.BK140104/0Terumo BCT, Inc10811 W. Collins Ave. Lakewood CO 8021504/01/14

DSM Biomedical PRP Device


Platelet And Plasma Separator For Bone Graft Handling
 

The DSM Biomedical PRP Device is designed to be used for the safe and rapid preparation of autlogous 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.
 

BK130053

DSM BIOMEDICAL 735 Pennsylvania Drive Exton PA 19341

Lic# 569260
 

3/25/2014
 

SmartPrep2 System


Platelet And Plasma Separator For Bone Graft Handling
 

Safe & Rapid preparation of autologous PRP from small sample of blood at patients point of care
 

BK130068

Harvest Technologies 40 Grissom Road Plymouth MA 02360

Lic# 571487
 

3/24/2014

Trima Accel System, Version 6.2


Automated Blood Cell Separators
 

Updates to Indications for Use Statement and Operator's Manual
 

BK130080
 

TERUMO BCT 10811 W. Collins Ave Lakewood CO 80215

Lic# 575216
 

3/19/2014
 

Blood Product Administration Module version 0.9


Stand alone Blood Bank Software
 

It is intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion.
 

BK130037
 

Epic Systems Corporation 1979 Milky Way Verona WI 53593

Lic# 564476
 

3/6/2014
 

AsiManager AT


Densitometer/Scanner (Integrating, reflectance, tlc,
radiochromat) Clinica

The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT
is designed to provide
standardized test interpretation, and provides for storage, retrieval, and transmittal of the test results.
It is intended to be acquired, possessed, and used only by health care professionals.
 

BK130001/0

Arlington Scientific, Inc. 1840 North Technology Dr.
Springville, UT 84663

2/24/14

Cymbal Automated Blood Collection System

Automated blood cell separator

Is intended to collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, from autologous and allogeneic donors.
 

BK130081/0

Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114

1/24/14

Erytra(R)


Automated Blood Grouping and Antibody Test Systems

The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological
testing of human blood utilizing DG Gel® 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests.
 

BK130067/0

Diagnostic Grifols,
S. A.
Passeig Fluvial, 24
08150 Parets del Valles Barcelona, SPAIN

1/17/14

Autologous Platelet Integrated Concentration (APIC) System


Platelet And Plasma Separator For Bone Graft Handling
 

System is indicated for the rapid preparation of autologous platelet rich plasma from a small sample of blood at the
patient's point of care. The platelet rich plasma is mixed with autograft and/or allograft bone prior to application to a bony defect for improving bone graft handling characteristics.
 

BK130060/0

Cytonics Corporation
555 Heritage Drive, Suite 115
Jupiter, FL 33458

1/17/14

Integrated Blood Bank Information System, version
3.0 (IBBIS)

Standalone Blood Bank Software

IBBIS version 3.0 is a computerized system of programs intended for use by trained blood bank personnel as an aid
in the entry and tracking of information related
to blood donor registration donation product manipulation, donation product distribution (shipping and receiving) and donor testing.
 

BK130054/0

LifeSouth Community Blood Centers
Inc.
4039 W. Newberry Road
Gainesville, FL 32607

1/17/14

Spectra Optia Apheresis System


Blood component separator

Blood component separator, may be used to perform procedures for collection of MNC and PMN from peripheral
blood

BK130065/0

Terumo BCT 10811 W. Collins Ave Lakewood, CO 80215-4440
 

1/16/14

Endoret Kit for
Platelet and Plasma Separator


Platelet and Plasma Separator

The system is designed to be used for the safe and rapid preparation of autologous
 

BK130049/0

B.T.I Biotechnology Institute, S.L.
Leonardo DaVinci 14
Parque Tecnologico De Alava
Minano,   SP

1/16/14