Vaccines, Blood & Biologics
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.
| Tradename | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| ALYX Component Collection System | For use in blood collection establishments to collect and separate whole blood into its components | BK100056 | Fenwal 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. | BK100049 | Charter Medical, Ltd. 3948-A Westpoint Blvd. Winston-Salem, NC 27103 | 12/7/2010 |
| INSTI™ HIV-1 Antibody Test Kit | Rapid 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 infections | BP090032 | bioLytical 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 transfusion | BK100050 | Fenwal Inc Three Corporate Drive 2nd Floor Lake Zurich, IL 60047 | 11/16/2010 |
| LifeTrak/Lab and Distribution 4.6.0 | Blood Establishment Software | BK100057 | Mediware 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. | BK100061 | Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202 P.O. Box 350 Raritan, NJ 08869-0606 | 10/28/2010 |
| LifeTrak/Donor 4.6.0 | Blood Establishment Software | BK100043 | Mediware Information Systems, Inc. 11711 West 79th St Lenexa, KS 66214 | 10/21/2010 |
| SGP Version 7.0 (Plasma Management System) | Blood Establishment Software | BK090082 | Biomat USA, Inc. 1311 Temple Ave City of Industry, CA 91746 | 10/1/2010 |
| RC-AID | An 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. | BK100037 | BBK 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. | BK100005 | ALBA Bioscience 21 Ellen's Glen Rd Liberton, Edinburgh EH17 7QT Scotland, United Kingdom | 8/26/2010 |
| Galileo Neo | A 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). | BK100033 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30091-5625 | 8/23/2010 |
| Instrument Manager 8.10.01 | Blood Establishment Software | BK100046 | Data Innovations Inc. 120 Kimball Ave. Suite 100 South Burlington, VT 05430 | 8/12/2010 |
| Trima Accel System Version 6.0 | Automated Blood Cell Separator intended for use in collecting blood components for later transfusion into patients | BK100032 | CaridianBCT 10811 W. Collins Avenue Lakewood, CO 80215-4498 | 8/6/2010 |
| Autopheresis - C Plasmapheresis System | To collect virtually cell-free plasma by membrane filtration. | BK100041 | Fenwal Inc Three Corporate Drive 2nd Floor Lake Zurich, IL 60047 | 8/5/2010 |
| Lab 21 TPHA OC Kit | For 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. | BK100024 | Lab 21 Healthcare Ltd 184 Cambridge Science Park Cambridge CB4 0GA United Kingdom | 8/3/2010 |
| Amicus Separator System | For 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. | BK100044 | Fenwal Blood Technologies Three Corporate Drive Lake Zurich, IL 60047 | 7/30/2010 |
| SoftBank II 25.1 | Blood Establishment Software | BK100045 | SCC 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.
| BK100040 | Ortho-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. | BK100014 | Circle Biologic, LLC 3650 Annapolis Lane, Suite 105 Minneapolis, MN 55447 | 7/9/2010 |
| Galileo | A 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. | BK090057 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30091-5625 | 7/9/2010 |
| Sanguin Liberty SRIMPORT | Blood 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 Software | BK090051 | McKesson Provider Technologies | 5/28/2010 |
| Trima Accel Automated Blood Component Collection System | Trima Accel System is an automated blood cell separator intended for use in collection of blood components for later transfusion into patients. | BK080029 | Gambro 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 | 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
| 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.
| 4/29/2010 |
| SoftID.Tx Version 1.0 | Blood Establishment Software | BK090078 | SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 | 4/28/2010 |
| CryoSC Freezing Bag | For 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. | BK090037 | Biosafe SA Route de Petit-Eysins Eysins, SZ | 3/22/2010 |
| HMS Blood Administration Module, Release 8.0 | Blood Establishment Software | BK090025 | Healthcare Management Systems, Inc. Nashville, TN 37203 | 3/4/2010 |
| AMICUS Separator System | To expand IFU for preparation of platelets to be stored with InterSol (PAS) | BK090065 | Fenwal Inc. Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 | 3/4/2010 |
| Component Manufacturing Interface for ElDorado Donor | To receive, parse, validate, and translate component manufacturing information from component manufacturing equipment. | BK100002 | Wyndgate Technologies 4925 Robert J. Matthews Parkway, Suite 100 El Dorado Hills, CA 95762 | 2/24/2010 |
| AMICUS Separator System | 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 post-count greater than 100,000 platelets/mL. | BK090058 | Fenwal Inc. Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 | 2/18/2010 |
| Trima Accel System | An automated blood cell separator intended for use in collecting blood components for later transfusion. | BK090003 | Caridian BCT
| 2/16/2010 |
| Fusionary Graft Delivery System | To aspirate bone marrow, autologous blood, plasma or other body fluids. | BK090047 | Spinesmith 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. | BK090069 | Biotechnology 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.
| BK090083 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 | 1/27/2010 |
| BBCS HospitalInterface Application (BBCSH), H 1.0.0 | Blood Establishment Software | BK090081 | Blood Bank Computer Systems, Inc. 1002 15th St. SW, Suite 120 Auburn, WA 98001-6502 | 1/20/2010 |
| OlympusPK7300 Automated Microplate System | A fully automated analyzer intended exclusively for agglutination technology using Olympus terraced microplates | BK090036 | Olympus 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 Software | BK090079 | Duley Hopkins and Associates 1200 Mountain Creek Road # 215 Chattanooga, TN 37405 | 1/13/2010 |
| CryoMACS Freezing Bag | For a single cycle of freezing, storage (down to -196C), and subsequent thawing (at 37C) of human blood components | BK090020 | Miltenyi Biotec, Inc. 120 Presidential Way Suite 305 Woburn, MA 01801 | 1/13/2010 |
| Picture-ID | Blood Establishment Software | BK090054 | Calimex USA Corporation 258 Hollister Ave Alameda, CA 94501 | 1/11/2010 |
