2008 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.
Complete list of currently active 510k applications and PMA applications.
Note: Applications are listed with the most recent action at the top.
Tradename | Description and Indication for Device | Number | Applicant | Approval Date |
---|---|---|---|---|
Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System | The Double Syringe (ACP) System is used to facilitate the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. | BK070069 | Arthrex Incorporated 1370 Creekside Boulevard Naples , FL 34108 |
12/12/2008 |
MEDITECH Client Server Blood Bank module v5.6 | The MEDITECH Blood Bank Software provides a variety of functionality for Healthcare Personnel. The software helps personnel, in both multiple and single facility organizations, manage their departments more efficiently by integrating donor, unit, and patient information. | BK080037 | MEDITECH Medical Information Technology, Inc. |
10/30/2008 |
HCLL Transfusion, v3.0 | HCLL Transfusion, version 3.0 is intended to address all phases of transfusion services activities, and assists transfusion service personnel. | BK080049 | Mediware Information Systems, Inc. 1900 Spring Road, Suite 450 Oak Brook Service Center Oak Brook, IL 60523 |
10/22/2008 |
AMICUS® Separator: Software 3.1 with EDI Export | The AMICUS Separator is intended to be used for the simultaneous collection of platelet concentrate, plasma and red blood cells while maintaining an extracorporeal volume at or below 10.5 mL/kg and a post-count greater than 100,000 platelets/µL. The AMICUS Separator is intended to be used for automated collection of mononuclear cells. |
BK080048 | Fenwal Inc. Three Corporate Drive Lake Zurich , IL 60047 |
10/2/2008 |
Cell Freeze Liquid Nitrogen Freezing Container | The Cell Freeze® Liquid Nitrogen Freezing Container is intended for the storage, preservation and transfer of peripherally derived stem cells, in liquid nitrogen to -196oC. The Cell Freeze® Liquid Nitrogen Freezing Container is provided sterile fluid path and intended for single use. | BK060042 | Charter Medical, Ltd. 3948-A Westpoint Blvd. Winston-Salem , NC 27103 |
10/3/2008 |
Atreus Whole Blood Processing System | The Atreus® Whole Blood Processing System is indicated for the automatic separation of one unit of CPD Whole Blood into two transfusable components: | BK080043 | CaridianBCT, Inc. 10811 W. Collins Avenue Lakewood , CO 80215-4498 |
9/29/2008 |
HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells | Indicated for pre-storage leukoreduction of a single unit of CPD/AS-1 Red Blood Cells. | BK080031 | Hemerus Medical, LLC 5000 Township Parkway Saint Paul , MN 55110 |
9/11/2008 |
MCS+ 9000 System | Intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets | BK080038 | Haemonetics Corporation 400 Wood Road Braintree , MA 02184 -9144 |
9/4/2008 |
Pool Results Manager | Blood Establishment Computer Software | BK080028 | Rubin & Poor, Inc. 155 Maplewood Avenue #5 Maplewood , NJ 07040 |
9/3/2008 |
COBE Spectra Apheresis System, |
The COBE Spectra Apheresis system is intended for use in therapeutic apheresis procedures involving patients and in the collection of blood components from donors. The Trima Automated Blood Collection System is intended for use in automated blood component collection procedures. | BK080035 | CaridianBCT 10811 W. Collins Avenue Lakewood , CO 80215-4498 |
8/29/2008 |
Amicus Separator System | Intended to be used for the simultaneous collection of platelet concentrate, plasma and red blood cells while maintaining an extracorporeal volume at or below 10.5 mL/kg and a post-count greater than 100,000 platelets/mL | BK080018 | Fenwal Blood Technologies |
8/26/2008 |
PLASMALINK | The Plasma Pooling Bottle is used for the collection, storage, and shipment of plasma prior to fractionation. | BK080033 | Fenwal Blood Technologies Three Corporate Drive Lake Zurich , IL 60047 |
8/22/2008 |
Cymbal Automated Blood Collection System | To collect two units of CP2D/AS-3 Red Blood Cells, Leukocytes Reduced from autologous and allogeneic donors | BK080025 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
8/15/2008 |
SoftBank II v23.2 | Blood Establishment Computer Software | BK080020 | SCC Soft Computer 5400 Tech Data Drive Clearwater FL 33760 |
8/12/2008 |
Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 | Blood Establishment Computer Software | BK080017 | LifeSouth Community Blood Centers Inc 4039 W. Newberry Road Gainesville FL 32607 |
8/5/2008 |
Donor Screen HLA Class I and Class II | To be used as an in vitro diagnostic kit in blood bank laboratories to screen blood donors for the presence of HLA Class I and Class II antibodies | BK070045 | GTI, INC 20925 Crossroads Circle Waukesha WI 53186 |
7/30/2008 |
XM-ONE Transplantation Cross Match | For use by professional laboratories in flow cytometric detection of antibodies in serum | BK070011 | AbSorber AB Drottninggatan 33 Stockholm, SWEDEN |
7/29/2008 |
ALBAcheck - BGS Reagent Control for Anti-D | For use as a negative control in conjunction with Alba Bioscience monoclonal Anti-D reagents | BK080027 | ALBA Bioscience 21 Ellen's Glen Road Liberton, Edinburgh EH17 7QT UNITED KINGDOM |
7/29/2008 |
Seraclone Control ABO+Rh Coombscell-E MLB2 |
(1) For use as a negative control in manual blood grouping with Seraclone ABO+Rh reagents, (2) For control of the manual antiglobulin test, (3) To potentiate antigen-antibody reactions in manual antibody screening, antibody identification, crossmatching, and typing with reagents requiring anti-human globulin reagent | BK080012 | Biotest Medical Diagnostics GmbH P.O. Box 102150 63267 Dreiech Germany |
7/23/2008 |
Alsever’s Solution (510(k) exempt but part of system) Solidscreen II Control B Solidscreen Negative Control Tango Optimo Automated Blood Bank Analyzer System with version 3.1 |
For use in ABO, Rh(D) (including weak D and partial D testing), Rh phenotyping, Kell blood grouping, antibody detection/screening, crossmatching, and direct antiglobulin tests(DAT) in patient and donor testing | BK080013 | Biotest Medical Diagnostics GmbH P.O. Box 102150 63267 Dreiech Germany |
7/23/2008 |
CytoTherm Plasma Thawing System | Used to thaw one unit of plasma | BK080019 | CytoTherm LP 110 Sewell Avenue Trenton, NJ 08610 |
7/16/2008 |
HLA EZ Type | Assay for the molecular determination of HLA Class I and Class II alleles at low resolution, using PCR amplification of human genomic DNA. | BK070034 | GTI, Inc. |
7/10/2008 |
ViroSeq HIV-1 Genotyping System v2.0 | For use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. | BK080026 | Celera Diagnostics, LLC |
7/10/2008 |
Donor Information System | Intended to receive, analyze, and store data during the collection and distribution of human plasma that will be used in plasma-derived bio-pharmaceutical products. | BK080016 | BioLife Plasma Services LP |
7/2/2008 |
The Atreus Whole Blood Processing System | For the automatic separation and leukoreduction of one unit of whole blood into its blood components, red blood cells, plasma and residual leukocytes. | BK080010 | Gambro BCT |
6/27/2008 |
ALYX Component Collection System | For use in blood collection facilities to collect and separate whole blood into its components. | BK080024 | Fenwal Inc. Three Corporate Drive Lake Zurich , IL 60047 |
6/24/2008 |
IntelliDOT Blood Product Administration | Assist in positive patient identification for the transfusion of blood products. | BK080006 | IntelliDOT Corporation 13520 Evening Creek Drive North, Suite 400 San Diego CA 92128 |
6/13/2008 |
PCS2 Plasma Collection System_Revision K Software | Intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets | BK080001 | Haemonetics Corporation |
5/28/2008 |
Defense Blood Standard System (DBSS) 10.0.0 | Blood Establishment Computer Software | BK070035 | Defense Blood Standard System |
5/22/2008 |
ePROGESA 5.0.1 | Blood Establishment Computer Software | BK080002 | MAK-System |
5/13/2008 |
DynaChip HLA Antibody Analysis System | Provides analysis of HLA antibodies | BK070041 | Invitrogen Corporation 9099 North Deerbrook Trail Brown Deer, WI 53223 |
4/30/2008 |
Blood Bank Information Management System (BBIMS) V2.05.01 |
Blood Establishment Computer Software | BK070065 | Duley Hopkins and Associates 1200 Mountain Creek Road #215 Chattanooga , TN 37405 |
4/25/2008 |
ABBOTT PRISM Director V2.0 | Assists laboratories by managing the sample test and retest function for multiple ABBOTT PRISM Systems. | BK080015 | Abbott Laboratories 100 Abbott Park Road Abbott Park , IL 60064-3500 |
4/24/2008 |
Pall Acrodose PLus System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter | Indicated for use to pool, leukocyte-reduce, and store ABO identical, whole-blood-derived platelets in the CLX@HP extended storage bag for up to 5 days after collection when used with a device cleared by FDA for detection of bacterial contamination in pooled, whole-blood-derived platelets | BK080003 | MEDSEP Corporation 16 Pepperwood Lane Pepper Pike , OH 44124 |
4/18/2008 |
VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls | For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System | BK070028 | Ortho-Clinical Diagnostics, Inc 100 Indigo Creek Drive Rochester, NY 14626-5101 |
4/10/2008 |
VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack |
For the in vitro detection of antibodies to Human Immunodeficiency virus types 1 and/or 2 in human serum and plasma | BP050051 | Ortho-Clinical Diagnostics, Inc 100 Indigo Creek Drive Rochester, NY 14626-5101 |
3/27/2008 |
Haemonetics PCS 2 Plasma Collection System, Wireless (W) Capable Modification | Intended for use as an automated cell separator system and blood component collector in conjunction with single use sterile disposable sets | BK060033 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
3/27/2008 |
HLA Fusion Software v 1.0 | Accessory for the evaluation of test results from One Lambda Incorporated products for typing and antibodies detection | BK070070 | One Lambda, Inc. 21001 Kittridge Street Canoga Park, CA 91303 |
3/10/2008 |
HaemoConnect (eLynx) | Intended to facilitate the collection and consolidation of procedure activities and their subsequent download or transfer to permanent storage systems, such as donor management, simple electronic file archives and optical and/or paper based archived | BK060051 | 5D Information Management Suite 500 10025-102A Avenue Edmonton, Canada T5J2Z2 |
3/6/2008 |
ElDorado Donor 1.0.0 | Blood Establishment Computer Software | BK070064 | Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills CA 95762 |
2/13/2008 |
Pall eBDS | For the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of apheresis and whole-blood-derived platelet products | BK070063 | Medsep Corporation 1630 Industrial Park Street, Covina, CA 91722 |
1/26/2008 |
TRUCISE Total System | Provide a sterile weld between 2 pieces of polyvinyl chloride tubing with optional information module | BK070018 | Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 |
1/22/2008 |
Fluido® Accessories: Fluido Air Guard, Fluido Compressor, Fluido IV-Pole and Fluido Pressure Chamber | To be used as accessories to the Fludio Blood- and Fluid Warmer | BK070055 | The Surgical Company International Terminalweg 19a Amersfoort, NETHERLANDS |
1/15/2008 |