2006 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 |
|---|---|---|---|---|
| SoftDonor 4.4. with DMSI 4.4 | Blood Establishment Computer Software | BK060059 | SSC Soft Computer 34350 U.S. Hwy 19 N. Palm Harbor, FL 34684 |
12/21/2006 |
| Medi-Temp III, Model FW600 Blood/Fluid Warmer | Intended to aid in the prevention of inadvertent hypothermia during administration of blood, blood products, and other fluids | BK060050 | Gaymar Industries, Inc 1700 Pennsylvania Avenue, N.W. Washington, DC 20006-4706 |
11/7/2006 |
| AmpliTrol III | Unassayed positive quality control reagent for use with in vitro diagnostic tests for the detection of HIV-1 RNA, HCV RNA, and HBV RNA in human serum or plasma from donations of whole blood and blood components for transfusion | BK060052 | Blackhawk BioSystems, Inc. 12945 Alcosta Blvd. San Ramon CA 94583 |
11/7/2006 |
| Genetic Systems HIV-1/HIV-2 PLUS O Ortho Assay Protocol Disk | Contains the pipetting parameters and analysis algorithms for Ortho Assay Software (OAS) and/or processing method for the Ortho Summit Processor (OSP) to run Bio-Rad's Genetic Systems HIV assay | BK050044 | Ortho-Clinical Diagnostics, Inc. 1001 U.S. Hwy 202 P.O. Box 350 Raritan, NJ 08869-0606 |
11/3/2006 |
| VistA Blood Establishment Computer Software (VBECS) 1.0 | Blood Establishment Computer Software | BK060043 | Dept of Veterans Affairs P.O. Box 7008 Hines, IL 60141-7008 |
10/19/2006 |
| BloodTrack 4.1 | Blood Establishment Computer Software | BK060041 | Neoteric Technology Ltd 205-1099 W. 8th Ave. Vancouver British Columbia V6H 1C3 CANADA |
10/17/2006 |
| GenesisCS Component Concentrating System | Designed to separate and individually aspirate chemicals and bodily fluids with minimal cross-contamination, particularly to sequester a high concentration of platelet-rich blood plasma for use in various medical procedures | BK050055 | Perfusion Partners & Associates, Inc 6227 Foxfire Lane Fort Myers, FL 33912 |
10/13/2006 |
| HemoCue Hb 301 System | Quantitative point-of-care whole blood hemoglobin determination in primary care or blood donation settings using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. | BK060048 | HemoCue AB Kuvettgatan 1 Angelholm, Sweden |
10/5/2006 |
| Pall Acrodose PL System, Platelet Pool and Store Set | Empty Containers for the Collection & Processing of Blood/Blood Components | BK060045 | Medsep Corp 16 Pepperwood Lane Pepper Pike, OH 44124 |
9/1/2006 |
| Pall Acrodose PL System, Platelet Pool and Store Set with eBDS | Empty Containers for the Collection & Processing of Blood/Blood Components | BK060044 | Medsep Corp 16 Pepperwood Lane Pepper Pike, OH 44124 |
9/1/2006 |
| ViroSeq HIV-1 Genotyping System | 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 | BK060049 | Celera Diagnostics, LLC 1401 Harbor Bay Pkwy Alameda, CA 94502 |
8/31/2006 |
| TANGO Automated Blood Bank Analyzer System | For use in ABO and Rh blood group determinations for patient and donor testing, including on receipt, independent confirmation of donor unit labeling; Antibody screening for detection of unexpected red cell alloantibodies | BK060034 | Olympus America, Inc. Diagnostic Systems Division 3131 West Royal Lane Irving, TX 75063-3104 |
8/28/2006 |
| LifeTec Elite 1.0 | Blood Establishment Computer Software | BK060032 | SysTec Computer Associates, Inc. 28 North Country Rd Mt. Sinai, NY 11766 |
8/21/2006 |
| ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV) | Human blood based control designed to be used as an independent, unassayed, external run control with in vitro tests for the detection of HIV-1 RNA, HCV RNA, HBV DNA, and West Nile Virus RNA (WNV) | BK060030 | BBI Diagnostics, A SeraCare Company 375 West Street West Bridgewater, MA 02379 |
8/18/2006 |
| CytoTherm Plasma Thawing System | Tabletop frozen plasma thawing system | BK060027 | CytoTherm LP 110 Sewell Avenue Trenton, NJ 08610 |
8/1/2006 |
| MICROAMS | Qualitative solid phase enzyme linked immunoassay (ELISA) designed to detect IgG Antibodies to donor-specific HLA class I and class II glycoproteins | BK060038 | GTI, INC 20925 Crossroads Circle Waukesha WI 53186 |
7/28/2006 |
| Talisman Phlebotomy System, Release 1.0 | Blood Establishment Computer Software | BK060031 | Talisman Ltd. 421 Church Street NE. Suite F Vienna VA 22180 |
7/27/2006 |
| Life Trak / Donor 3.01 | Blood Establishment Computer Software | BK060019 | Mediware Information Systems, Inc 4545 Fuller Drive Suite 320 Irving, TX 75038 |
6/21/2006 |
| ACCURUN 365 West Nile Virus RNA Positive Quality Control | Used as an independent, unassayed, external run control with in vitro tests for the detection of West Nile Virus RNA | BK060022 | BBI Diagnostics, A SeraCare Company 375 West St West Bridgewater, MA 02379 |
6/12/2006 |
| Abbott PRISM Retest Server | Blood Establishment Computer Software | BK060028 | Abbott Laboratories 100 Abbott Park Rd Abbott Park , IL 60064-3500 |
6/7/2006 |
| Chembio HIV Reactive/Nonreactive Controls SURE CHECK HIV 1/2 ASSAY |
For the detection of antibodies to HIV 1 & 2 in fingerstick whole blood, venous whole blood, and serum or plasma specimens | BP050009 | Chembio Diagnostic Systems, Inc 3661 Horseblock Road Medford, NY 11763 |
5/25/2006 |
| Chembio HIV 1/2 STAT-PAK ASSAY | For the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. | BP050010 | Chembio Diagnostic Systems, Inc 3661 Horseblock Road Medford, NY 11763 |
5/25/2006 |
| E-Interview (eQue) 1.0.0 | Blood Establishment Computer Software | BK050060 | Fifth Dimension Information Systems 10025-102A Ave Suite 500 Edmonton, Canada T5J 2Z2 |
5/24/2006 |
| Haemonetics ACP 215 Glycerolization/Deglycerolization System | Intended to glycerolize and deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for up to 6 days at 1-6°C prior to glycerolization | BK060008 | Haemonetics Corp 400 Wood Rd Braintree, MA 02184 |
5/23/2006 |
| Haemonetics MCS+ 8150 Apheresis System | Used to collect blood components from allogeneic and autologous donors | BK060023 | Haemonetics Corp 400 Wood Rd Braintree, MA 02184 |
5/23/2006 |
| ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents | For the qualitative determination of antibodies to the human immunodeficiency virus type 1, including group O, and/or type 2 in serum or plasma using the ADVIA Centaur System | BP050030 | Bayer HealthCare 511 Benedict Ave Tarrytown, NY 10591 |
5/18/2006 |
| Donor Information System (DIS) 3.2 | Blood Establishment Computer Software | BK060017 | BioLife Plasma Services LP One Baxter Parkway Deerfield , IL 60015 |
5/9/2006 |
| corQC Test System | Daily Quality Control System for Routine Blood Bank Reagents | BK060016 | Immucor, Inc 3130 Gateway Drive Norcross, A 30091-5625 |
5/9/2006 |
| Fluido Blood and Fluid Warmer System | Designed for use to warm blood and fluids before administration | BK050058 | The Surgical Co Int’l Terminalweg 19a Amersfoort, Netherlands 3821AJ |
5/5/2006 |
| Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System | For the rapid preparation of autologous platelet-rich concentrate (PRC) from a small sample of blood at the patient's point of care | BK060004 | Smith & Nephew, Inc 1450 Brooks Road Memphis, TN 38116 |
5/2/2006 |
| Galileo Automated Blood Bank System with Capture-S Syphilis Screening Assay | Designed to fully automate immunohematology in vitro diagnostic testing of human blood | BK060009 | Immucor, Inc 3130 Gateway Drive Norcross , GA 30091-5625 |
4/11/2006 |
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | Software for detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs and aid in monitoring and treating HIV infection | BK060015 | Bayer HealthCare Diagnostics Division P.O. Box 2466 Berkeley, CA 94702-5828 |
3/21/2006 |
| Procleix System | Blood Establishment Computer Software | BK060012 | Gen-Probe 10210 Genetic Center Dr San Diego, CA 92121-4362 |
3/15/2006 |
| GranType | Alternative to serological typing of the HNA-1 polymorphism in granulocytes | BK050054 | GTI, Inc 20925 Crossroads Circle Waukesha WI 53186 |
3/2/2006 |
| Chiron Procleix NAT Tracker 3.0 | Blood Establishment Computer Software | BK060005 | Chiron Corp 4560 Horton St Emeryville, CA 94608 |
3/1/2006 |
| COBE Angel Whole Blood Separation System | Intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets produced can be used for diagnostic tests. The platelet rich plasma from the COBE® Angel Whole Blood Separation System can also be mixed with autograft and/or allograft bone prior to application to an orthopedic site as deemed necessary by the clinical use requirements | BK060010 | COBE Cardiovascular, Inc 14401 West 65th Way Arvada, CO 80004-3599 |
2/27/2006 |
| BD Vacutainer Plus K2EDTA Tubes; BD Vacutainer Plus Serum Tubes; BD Vacutainer SST Glass Tubes; BD Vacutainer SST II Advance Tubes; BD Vacutainer SST Plus Tubes | Intended for routine blood donor screening and diagnostic testing of serum for infectious disease. The performance characteristics of these tubes have not been established for infectious disease testing in general; therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions | BK050036 | Becton, Dickinson & Co 1 Becton Dr, MC 300 Franklin Lakes, NJ 07417 |
2/24/2006 |
| Cascade Medical FIBRINET System | Intended 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 can be mixed with autograft and allograft bone prior to the application to an orthopedic surgical site as deemed necessary by the clinical use requirements | BK060006 | Cascade Medical Enterprises, LLC 20 Greenup Ct Wayne, NJ 07470 |
2/16/2006 |
| BD HLA-B27 System | Qualitative two-color direct immunofluorescence method for the rapid detection of HLA-B27 antigen expression in erythrocyte-lysed whole blood (LWB) using the BD FACSCanto flow cytometer, or the BD FACSCalibur, BD FACSort, or BD FACScan flow cytometers | BK050073 | BD Biosciences 2350 Qume Drive San Jose CA 95131-1807 |
2/16/2006 |
| HLA Visual Software version 1.0 | Accessory for the evaluation of test results from One Lambda Inc products for molecular typing and antibodies detection | BK050070 | One Lambda, Inc 21001 Kittridge St. Canoga Park CA 91303 |
1/30/2006 |
| HLATools Software, Version 1.0 | To aid in assigning Major and /or Minor Histocompatibility Compexes | BK050071 | One Lambda, Inc 21001 Kittridge St. Canoga Park CA 91303 |
1/30/2006 |
| Pall Acrodose PL System | Intended to be used to pool and store whole-blood-derived, leukocyte-reduced platelets in the CLX HP extended storage bag for up to 5 days | BK050074 | Medsep Corporation 19 Pepperwood Lane Pepper Pike, OH 44124 |
1/26/2006 |
| ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) | Alternatives to platelet serological testing and an adjunct to HLA matching in selecting compatible platelets for recipients | BK050040 | GTI, INC 20925 Crossroads Circle Waukesha, WI 53186 |
1/20/2006 |
| Genetic Systems HbsAg EIA 3.0 Ortho Assay Protocol Disk | Contains the pipetting parameters and analysis algorithms for Ortho Assay Software and/or processing method for the Ortho Summit Processor to run Bio-Rad's Genetic Systems HBsAg EIA 3.0, the assay specified on the disk label | BK050046 | Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 P.O. Box 350 Raritan, NJ 08869-0606 |
1/13/2006 |