2007 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 |
|---|---|---|---|---|
| IDM Symphony System 2.0 | Stand alone blood bank software | BK070031 | Information Data Management, Inc. 9701 West Higgins Road Rosemont, IL 60018 |
12/13/2007 |
| Vista Information System, Version 3.0 with Medical Review Module | Stand alone blood bank software | BK070066 | Gambro BCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215-4498 |
12/13/2007 |
| Galileo Automated Blood Bank System Reverse ABO Group Assay | Microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood | BK070054 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
11/30/2007 |
| Vortech Concentration System | Production of platelet-poor plasma concentrate | BK070036 | Biomet Biologics, Inc. P.O. Box 587 56 East Bell Drive Warsaw, IN 46582-0587 |
11/21/2007 |
| Immucor's WB corQC | Used on the Galileo Echo Instrument for daily quality control of blood bank reagents | BK070051 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30091-5625 |
11/16/2007 |
| PROGESA 4.4h | Modular, stand-alone software application to meet the needs of community blood banks or transfusion services | BK070062 | MAK-System 10 Avenue de la Grande Armee France |
10/26/2007 |
| AXP AutoXpress Platform | The ThermoGenesis AXP AutoExpress Platform is a cord blood cell processing system intended for laboratory use in combination with a specific and compatible single-use separation kit supplied by ThermoGenesis. The AXP system provides for automated, rapid, and consistent aseptic separation of cord blood in a closed environment using sterile, non-pyrogenic materials | BK070006 | ThermoGenesis Corp 2711 Citrus Road Rancho Cordova, CA 95742 |
10/5/2007 |
| TypeSafe Segment Dispenser | The TypeSafe Segment Dispenser provides a safe means to puncture segments containing blood and convenient means to dispense blood from a segment into a test tube. It is for single specimen use | BK070037 | Typenex Medical LLC 303 East Wacker Dr Chicago, IL 60601 |
10/5/2007 |
| corQC Extend | corQC Extend cell comprises five cells. They are group O, single donor, red blood cells. corQC Extend cells are used for the manual tube and automated (Galileo) assays for quality control evaluation of routine Rh and Kell blood grouping reagents | BK070039 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
9/28/2007 |
| Galileo Automated Blood Bank System with assays to perform red blood cell phenotying | A microporcessor controlled instrument to automate immunohematology in vitro diagnostic testing of human blood using a microplate platform. It automates test processing, result interpretation and data management functions. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening such as syphilis and cytomegalovirus (CMV). | BK070040 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
9/28/2007 |
| UniMatch Plus Version 4.0 | UniMatch Plus supports evaluation of HLA typing results. This submission is to update the device algorithm. | BK070046 | Invitrogen Corp 9099 North Deerbrook Trail Brown Deer WI 53223 |
9/27/2007 |
| Pall Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter and eBDS | To pool leukocyte-reduce, and store ABO identical, whold blood -derived platelets in the CLX HP extended storage bag for up to 5 days after collection when used with the eBDS Sample Set in combination with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of pooled whole blood derived platelet products stored in plasma. | BK070056 | Medsep Corp 1630 Industrial Park Street Covina, CA 91722 |
9/27/2007 |
| Pall Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter | The Pall AcrodoseTM PLUS System, Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter (Acrodose PL Leukocyte Reduction Filter), is 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. | BK070057 | Medsep Corp 1630 Industrial Park Street Covina, CA 91722 |
9/27/2007 |
| AllSet Gold SSP | PCR based HLA typing evaluation method designed to provide resolution of the HLA Class I (A, B, C) and Class II (DRβ DQβ) Loci using genomic DNA | BK070038 | Invitrogen Corp 9099 North Deerbrook Trail Brown Deer WI 53223 |
9/26/2007 |
| S-Monovette ACD-A | Blood Collection System- Blood collection, processing, and transportation device producing an anticoagulated specimen for Blood Bank testing, histocompatibility and blood group determination. | BK070029 | Sarstedt, Inc P.O. Box 468 Newton, NC 28658 |
9/21/2007 |
| Autologel System | The AutoloGel System is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of patient blood. The AutoloGel System is indicated for use in the treatment of non-healing wounds, such as diabetic, venous, and pressure ulcers, dehiscence wounds, and for the management of surgically-debrided wounds. | BK060007 | Cytomedix, Inc 416 Hungerford Dr Rockville, MD 20850 |
9/20/2007 |
| Olympus PK CMV-PA Test System and Controls Olympus PK7300 Automated Blood Bank Analyzer |
Automated PK7300 Blood Bank Analyzer for use in screening for antibodies to Cytomegalovirus. | BK070030 | Fujirebio Diagnostics, Inc 201 Great Valley Parkway, Malvern, PA 19355 |
9/20/2007 |
| Platelet PGD Test System | Rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in leukocyte reduced apheresis platelets (LRAP) as an adjunct quality control test following testing with a bacterial detection device cleared by the FDA for quality control testing of LRAP | BK070044 | Verax Biomedical Inc 377 Plantation St., Biotech 4 Worcester, MA 01605 |
9/17/2007 |
| HEMERUS Medical LLC | Leukocyte reduction filtration system | BK070024 | Hemerus Medical, LLC 5000 Township Parkway Saint Paul, MN 55110 |
8/23/2007 |
| AlbaQ-Chek Simulated Whole Blood Controls | For use as controls of blood grouping reagents in column agglutination techniques | BK070033 | Alba Bioscience 21 Ellen's Glen Road Liberton, Edinburgh EH17 7QT Scotland United Kingdom |
7/27/2007 |
| CryoSeal FS System | For use in the automated preparation of fibrin sealant from a single unit of autologous human plasma only in a closed, sterile fluid path. The autologous fibrin sealant prepared by this device is indicated for use as an adjunct to hemostasis on the incised liver surface in patients undergoing liver resection when control of bleeding by standard surgical techniques is ineffective or impractical. | BP060001 | ThermoGenesis Corp. 2711 Citrus Road Rancho Cordova CA 95742 |
7/26/2007 |
| Quality Donor System v2.1 | Blood Establishment Computer Software | BK070020 | Talisman Ltd 421 Church Street NE. Suite F Vienna VA 22180 |
7/16/2007 |
| Vista Information System 3.0 | Blood Establishment Computer Software | BK070001 | Gambro BCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215-4498 |
6/27/2007 |
| Pall eBDS | For use with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of apheresis and single and pooled units of whole blood derived platelet products stored in plasma | BK070004 | Medsep Corp 1630 Industrial Park Street Covina, CA 91722 |
6/26/2007 |
| Olympus PK TP Reagent System | For the quantitative screening of blood donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum or EDTA plasma using the OLYMPUS PK7200 and/or PK7300, Automated Microplate System | BK060062 | Fujirebio Diagnostics, Inc 201 Great Valley Parkway Malvern, PA 19355 |
6/25/2007 |
| Galileo Echo Automated Blood Bank System | Microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood | BK070016 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
6/14/2007 |
| WB corQC | A set of reagent red blood cells of varying antigenic and antibody makeup. WB corQC reagent red blood cells are incorporated as run controls with blood sample testing for the daily quality control of blood bank reagents on the Galileo Echo instrument. | BK070015 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
6/14/2007 |
| DAT Positive Control Cell | To be used only with Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. | BK070014 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
6/14/2007 |
| Monoclonal Control | To be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in Slide, Tube, and Microplate Tests | BK070013 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
6/14/2007 |
| GPS III Platelet Concentrate Separation Kit with ACD-A (also marketed in "Mini" and "Double Kit" packages) | 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 can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by clinical use requirements. | BK070026 | Biomet, Inc P.O. Box 587 56 East Bell Drive Warsaw, IN 46582-0587 |
6/6/2007 |
| Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 | Blood Establishment Computer Software | BK060037 | Cerner Corp 2800 Rock Creek Parkway Kansas City MO 64117-2551 |
5/24/2007 |
| ElDorado Donor Doc 1.0.0 | Blood Establishment Computer Software - Staff or Self Administered Donor Health History Questionnaire | BK070010 | Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills CA 95762 |
5/23/2007 |
| Haemonetics PCS2 Plasma Collection System | For use as an automated cell separator system and blood component collector in conjunction with a single use sterilized disposable set | BK070019 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
5/23/2007 |
| Olympus Bromelin; Olympus PK7300 Automated Microplate System; Olympus System Control | The Olympus PK7300 Automated Microplate System is a fully automated analyzer intended exclusively for agglutination technology using Olympus terraced microplates. The PK7300 can be used to perform donor ABO/Rh grouping, including weak D testing, and Rh and Kell Phenotyping. The control is a specially prepared reagent, devoid of antibody activity, for use in parallel testing with ABO/Rh typing sera to differentiate between specific agglutination in non-specific reactions. | BK060024 | Olympus America, Inc Diagnostic Systems Division 3131 West Royal Lane Irving, TX 75063-3104 |
5/14/2007 |
| COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L | Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers | BP050069/0 | Roche Molecular Systems, Inc 4300 Hacienda Drive PO. Box 9002 Pleasanton CA 94566-0990 |
5/11/2007 |
| Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit |
Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers | BP060002/0 | ABBOTT Molecular, Inc 1300 E. Touhy Avenue Des Plaines, IL 60018 |
5/11/2007 |
| Patient Health Software 1.0 | Blood Establishment Computer Software | BK060035 | MAK-System 10 Avenue de la Grande Armée 75017 Paris France |
5/9/2007 |
| CytoTherm Cryoprecipitate Thawer, Model CT-4T.6C | A tabletop unit which can be attached to any cooling device to lower the thawing temperature. It can thaw up to 12 plasma bags at a time, keeping bag ports dry. | BK060063 | CytoTherm LP 110 Sewell Avenue Trenton, NJ 08610 |
5/4/2007 |
| Antibody Check 4.1 | Blood Establishment Computer Software | BK060056 | Prescott Ideas, LLC 8960 E. Anna Place Tucson, AZ 85710 |
4/23/2007 |
| Pall Acrodose PL System, Platelet Pool and Store Set with in-line Leukocyte Reduction Filter | Indicated for use to pool, leukocyte-reduce, and store 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. | BK060040 | Medsep Corp 16 Pepperwood Lane Pepper Pike, OH 44124 |
4/12/2007 |
| Pall eBDS | For use with the Pall eBDS Oxygen Analyzer in the qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of leukocyte-reduced apheresis and single and pooled units of whole-blood-derived platelet products. | BK060047 | Medsep Corp 16 Pepperwood Lane Pepper Pike, OH 44124 |
4/4/2007 |
| PowerBANK Enterprise Edition 1.0 | Blood Establishment Computer Software | BK060014 | Mosum Technology India PVT Ltd 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
3/30/2007 |
| Morgan HLA SSP ABDR Typing Kit | Provides the HLA-A, HLA-B and HLA-DRB typing results with a low to medium resolution by a DNA-based method. | BK060060 | Texas BioGene, Inc 635 Presidential Drive Richardson TX 75081 |
3/22/2007 |
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | Intended 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. | BK070009 | Siemens Medical School Diagnostics P.O. Box 2466 Berkeley, CA 94702-0466 |
3/19/2007 |
| PROCLEIX NAT TRACKER | Blood Establishment Computer Software | BK070007 | Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 |
3/6/2007 |
| Cymbal Automated Blood Collection System | Intended to collect two units of leukoreduced red cells collected/stored in CP2D/AS-3 from autologous and allogeneic donors | BK060057 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
2/28/2007 |
| GPS II Platelet Concentration Separation Kit with ACD-A Plasmax Plasma Concentrator with GPS Mini Platelet Concentrate Separation Kit with ACD-A | For the rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by clinical use requirements. | BK070003 | Biomet, Inc. P.O. Box 587 56 East Bell Drive Warsaw, IN 46582-0587 |
2/22/2007 |
| Procleix TIGRIS System for use with the Procleix WNV Assay | Only intended for use with Procleix Assays for in vitro diagnostic use that have package inserts with Procleix TIGRIS System instructions | BK060021 | Gen-Probe, Inc 10210 Genetic Center Dr San Diego CA 92121-4362 |
2/20/2007 |
| Bd.id Patient Identification System for Transfusion Management V7.00 | Blood Establishment Computer Software | BK060046 | Becton, Dickinson & Company 1 Becton Drive, MC 300 Franklin Lakes NJ 07417-1885 |
2/13/2007 |
| ALYX Component Collection System: ALYX 2RBC-NLR Kit | For use in blood collection establishments to collect and separate whole blood into its components | BK060061 | Baxter Healthcare Corp 1620 Waukegan Road McGaw Park, IL 60085 |
2/9/2007 |
| Donor-ID 3.0 | Blood Establishment Computer Software | BK060058 | Healthcare-ID 1635 Barclay Blvd Buffalo Grove IL 60089 |
2/8/2007 |
| VeriSure Pro HBV DNA External Quality Control | For use with the Procleix Ultrio Assay and no other HBV assay for the detection of hepatitis B virus (HBV) DNA in human plasma from donations of whole blood and blood components for transfusion | BK060064 | AcroMetrix Corporation 6058 Egret Court Benicia, CA 94510 |
2/8/2007 |
| MEDITECH MAGIC Blood Bank Software 4.9 | Blood Establishment Computer Software | BK060029 | MEDITECH Medical Information Technology, Inc MEDITECH Circle Westwood, MA 02090 |
2/6/2007 |
| TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 | Automated Blood Grouping and Antibody Test System | BK060066 | Biotest AG Postfach 10 20 40 D-63266 Dreiech, Germany |
1/17/2007 |
| Instrument Manager 8.05.01.10 | Intended to be used by trained laboratory personnel in a blood-banking environment as an aid in interfacing and managing data between blood bank automated instruments and Blood Establishment Computer Software (BECS) | BK060053 | Data Innovations Inc. 120 Kimball Ave., Suite 100 South Burlington VT 05430 |
1/5/2007 |
| Sepax Cell Separation System and single use kits | Allows the fast, automated and reproducible separation of cord blood in a closed and sterile environment | BK060036 | Biosafe SA Biologics Consulting Group 1317 King Street Alexandria, VA 22314 |
1/3/2007 |