Vaccines, Blood & Biologics
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 Device||Submission ID||Manufacturer||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
Cellmedix Holdings, LLC.19 Park Drive Franklin NJ 7416
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:
Sunquest Information Systems, Inc.
|BeadCheck HEA Positive Control BeadCheck HEA Positive Control||The 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.
|BK130050/0||BioArray Solutions, Ltd. |
35 Technology Drive Warren NJ 07059
|BioArray Imaging System (AIS) 400C Instrumentation for Clinical Multiplex Test Systems||It is an automated image acquisition system designed for use with BioArray Solutions BeadChips Kits||BK130051/0||BioArray Solutions, Ltd. |
35 Technology Drive Warren NJ 07059
|DG Reader Manual blood grouping and antibody test systems||It is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards.||BK140101/0||Diagnostic Grifols, Passeig Fluvial, 24,|
Parets Del Valles,
|Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test Molecular erythrocyte typing test||PreciseType, 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.||BP130026/0||BioArray Solutions, Ltd. 35 Technology Drive, Warren, NJ 07059||05/21/14|
|Blood Administration Version 1800/Stand alone Blood Bank Software||Manage all processes associated with the handling and utilization of blood units and components within the hospital.||BK130003/0||CPSI 6600 Wall Street Mobile AL 36695||04/30/14|
|Procleix NAT Manager Software (Version 1.1) /Stand alone Blood Bank Software||Procleix 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 personnel01||BK130052/0||STRATEC Biomedical UK Limited1 Barberry Court, Callister Way||04/17/14|
|DG Gel Extended Control /Quality Control Kits for Blood Banking Reagents||For 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 antibodies||BK140092/0||Medion Grifols Diagnostics AG Bonnstrasse 9 Duedingen||04/11/14|
|DoVac Elite v 2.0 /Stand alone Blood Bank Software||The 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 system||BK140091/0||IT Synergistics, LLC 115 Tree Street Flowood MS 39232||04/09/14|
|Vista Information System Version 3.2/ Stand alone Blood Bank Software||Provide 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.||BK140104/0||Terumo BCT, Inc10811 W. Collins Ave. Lakewood CO 80215||04/01/14|
DSM Biomedical PRP Device
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.
DSM BIOMEDICAL 735 Pennsylvania Drive Exton PA 19341
Safe & Rapid preparation of autologous PRP from small sample of blood at patients point of care
Harvest Technologies 40 Grissom Road Plymouth MA 02360
Updates to Indications for Use Statement and Operator's Manual
TERUMO BCT 10811 W. Collins Ave Lakewood CO 80215
It is intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion.
Epic Systems Corporation 1979 Milky Way Verona WI 53593
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
Arlington Scientific, Inc. 1840 North Technology Dr.
Cymbal Automated Blood Collection System
Is intended to collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, from autologous and allogeneic donors.
The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological
Autologous Platelet Integrated Concentration (APIC) System
System is indicated for the rapid preparation of autologous platelet rich plasma from a small sample of blood at the
Integrated Blood Bank Information System, version
IBBIS version 3.0 is a computerized system of programs intended for use by trained blood bank personnel as an aid
LifeSouth Community Blood Centers
Blood component separator, may be used to perform procedures for collection of MNC and PMN from peripheral
Terumo BCT 10811 W. Collins Ave Lakewood, CO 80215-4440
The system is designed to be used for the safe and rapid preparation of autologous
B.T.I Biotechnology Institute, S.L.