2005 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 | Number | Applicant | Approval Date |
|---|---|---|---|---|
| BacT/ALERT BPN Culture Bottle | Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC) | BK050043 | bioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
12/27/2005 |
| BacT/ALERT BPA Culture Bottle | Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC) | BK050037 | bioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
12/27/2005 |
| System for Plasma Identification (SPI) 2.0.0 | Blood Establishment Computer Software - Plasma Tracking and Post Donation Test Results | BK050078 | ZLB Behring AG Wankdorfstrasse 10 Postfach 3000 Bern 22 Switzerland |
12/22/2005 |
| VeriSure Pro West Nile Virus (WNV) RNA External Quality Controls: VeriSure Pro WNV RNA Negative External Quality Control VeriSure Pro WNV RNA Positive External Quality Control |
For use with the Procleix System for the detection of West Nile Virus (WNV) in human plasma from donations of whole blood and blood components for transfusion. The VeriSure Pro WNV RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of the Procleix Assay and has the potential for detecting systematic deviations of the Procleix assay for the qualitative determination of WNV. | BK050061 | AcroMetrix Corp 6058 Egret Court Benicia, CA 94510 |
12/21/2005 |
| 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 leukocyte reduced apheresis and whole blood derived platelet products | BK050075 | Medsep Corp 19 Pepperwood Lane Pepper Pike, OH 44124 |
12/20/2005 |
| TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0) | For use in ABO and Rh 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 | BK050076 | Olympus America Inc Diagnostic Systems Division 3131 West Royal Lane Irving TX 75063-3104 |
12/16/2005 |
| BloodTrack Courier 3.2 | Blood Establishment Computer Software | BK050059 | Neoteric Technology Ltd 205-1099 W. 8th Ave Vancouver, Canada |
12/13/2005 |
| UltraChek Reference Controls - Product Code GLK UltraCrit Hematocrit Measurement Device - Product Code GKF |
To monitor and evaluate the analytical performance of the UltraCrit device for the measurement of hematocrit; to quantitatively measure hematocrit (Hct) levels in human whole blood for the purpose of screening suitable blood donors for the blood banking industry | BK050056 | Separation Technology, Inc 1096 Rainier Drive Altamonte Springs, FL 32714-3855 |
12/12/2005 |
| Aldecount Progenitor Cell Enumeration Kit | For general diagnostic purpose to enumerate ALDH (bright) SSC (lo) cells in fresh or frozen clinical samples. These samples can be from normal donors, donors mobilized with granulocyte stimulating factor (G-CSF) or some other mobilizing agent or patients that have been mobilized or treated with chemotherapeutic agents. | BK050052 | STEMCO Biomedical, Inc 2810 Meridan Pkwy Suite 148 Durham, NC 27713 |
12/2/2005 |
| MCS+9000, SDP revision E software, 994CF-CPP series disposable sets | To collect one unit of platelets, leukocyte reduced (with or without plasma). Additionally, the set may be used to collect two units of platelets, leukocyte reduced. The collected platelets may be stored up to 7 days and must be coupled with 100% screening for bacterial contamination using a device cleared for that purpose with its recommended method prior to transfusion) | BK050047 | Haemonetics Corp 400 Wood Road Braintree, MA 02184-9144 |
11/21/2005 |
| Procleix System for the Procleix WNV Assay | For use as an integrated software/equipment system to be used in conjunction with blood screening assays | BK050042 | Gen-Probe 10210 Genetic Center Drive San Diego, CA 92121-4362 |
11/15/2005 |
| Galileo Automated Blood Bank System Capture-CMV |
Microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo automates test processing, result interpretation and data management functions. The Galileo 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 and infectious disease screening such as syphilis and cytomegalovirus (CMV) | BK050050 | Immucor, Inc 3130 Gateway Drive Norcross GA 30091-5625 |
11/14/2005 |
| AMICUS Separator System | Simultaneous collection of platelet concentrate, plasma and red blood cells | BK050038 | Baxter Healthcare Corp 1620 Waukegan Road McGaw Park, IL 60085 |
11/3/2005 |
| BD HLA-B27 kit | Qualitative two-color direct immunofluorescence method for the rapid detection of HLA-B27 antigen expression in erythrocyte-lysed whole blood (LWB) using the BD FACSCalibur, BD FACSort, or BD FACScan flow cytometers | BK050062 | BD Biosciences 2350 Qume Drive San Jose CA 95131-1807 |
10/27/2005 |
| SoftDonor 4.3 with SoftScape 1.2.0 | Blood Establishment Computer Software - Blood Donor Service Software | BK050045 | SCC Soft Computer 34350 U.S. Highway 19 North Palm Harbor FL 34684 |
10/26/2005 |
| Leucolab LCG2 Leukoreduction System for Red Blood Cells | Indicated for the leukoreduction of a single unit of red cells, at room temperature (20 to 24 C) within 8 hours of collection, or at 1 to 6 C up to 3 days after collection. The storage period for the Leukoreduced Red Blood Cells is determined by the anticoagulant or preservative solution used in their manufacture | BK050041 | MacoProductions S.A.S. 2335 Massey Lane Decatur, GA 30033 |
10/12/2005 |
| Monitor Blood Administration Module Release 24.0 | Blood Establishment Computer Software | BK050001 | Healthcare Management Systems, Inc 3102 West End Avenue, Suite 400 Nashville TN 37203 |
9/28/2005 |
| Pall Acrodose PL System, Platelet Pool and Store Set with eBDS Pall Platelet Pool and Store Set | 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 and, with the Pall eBDS Oxygen Analyzer, in qualitative procedures to detect aerobic and facultative anaerobic microorganisms (bacteria) in the pooled platelets for quality control purposes | BK050034 | Medsep Corp 1630 Industrial Park Street Covina, CA 91722 |
9/28/2005 |
| Haemonetics MCS + 8150 Apheresis System | Intended to be used with the 2 RBC-F protocol and the 832F disposable set to collect two units of filtered red cells from autologous and allogeneic donors. Filtration must be done within 8 hours if the red cells are at room temperature or within 72 hours if the red cells are stored at 1-6 C | BK050048 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
9/27/2005 |
| Quant-Rho FITC Anti-D for Fetal Cell Assay | For the estimation of fetomaternal haemorrage by in vitro labeling of RhD+ve cells for analysis by flow cytometry | BK050005 | ALBA Bioscience 21 Ellen's Glen Road Liberton, Edinburgh EH17 7QT Scotland, UK |
9/27/2005 |
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | Blood Establishment Computer Software | BK050035 | Bayer HealthCare Diagnostics Division P.O. Box 2466 Berkeley, CA 94702-5828 |
9/20/2005 |
| 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. It 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 | BK050033 | COBE Cardiovascular, Inc 14401 West 65th Way Arvada, CO 80004 |
8/22/2005 |
| BloodTrack SafeTx Version 2.0 | Intended for use in hospitals by healthcare professionals trained in administration of blood to increase transfusion safety by providing positive patient ID at bedside when samples are collected, and at time of transfusion of blood or blood products | BK050032 | Neoteric Technology Ltd 205-1099 W. 8th Ave Vancouver, Canada |
8/16/2005 |
| CareChek Patient Identification System, CareChek TX, Version 1.0 | Blood Establishment Computer Software | BK040053 | Korchek Technologies, LLC 770 Plattsville Road Trumbull, CT 06611 |
8/12/2005 |
| Charter Medical Transfer Set | To obtain an aliquot of blood or blood components and/or to perform a sterile transfer of blood or blood components from one container to another | BK050021 | Charter Medical, Ltd 3948-A Westpoint Blvd Winston-Salem, NC 27103 |
7/22/2005 |
| GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory | For the safe and rapid preparation of autologous platelet-rich-plasma (PRP) and concentrated platelet poor plasma (PPPc) from a small sample of blood at the patient's point of care | BK050016 | Biomet, Inc P.O. Box 587 56 East Bell Drive Warsaw, IN 46582 |
7/20/2005 |
| IDM Prelude System, Version 1.1 | Blood Establishment Computer Software | BK050014 | Information Data Management, Inc 9701 W. Higgins Rd Rosemont, IL 60018 |
7/18/2005 |
| LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 100 | Qualitative test (in vitro diagnostic kits) for the DNA typing of Class I and Class II HLA alleles | BK050003 | Tepnel Lifecodes Corp 550 West Avenue Stamford, CT 06902 |
7/18/2005 |
| LABScreen Software | Assists in determining the presence or absence of HLA antibodies | BK050008 | One Lambda, Inc 21001 Kittridge St Canoga Park, CA 91303 |
7/8/2005 |
| Donor Information System (DIS) 3.1 | Blood Establishment Computer Software | BK050029 | BioLife Plasma Services LP One Baxter Parkway Deerfield, IL 60015 |
7/7/2005 |
| Greiner Vacuette No Additive Tubes | Collect, transport, and process blood for testing serum or clotted red blood cells in the immunohematology laboratory, i.e. red cell grouping, Rh typing and antibody screens | BK050026 | Greiner Bio-One North America, Inc 4238 Capital Drive Monroe, NC 28110 |
7/7/2005 |
| Greiner Vacuette Clot Activator Tube | Collect, transport, and process blood for testing serum or clotted cells in the immunohematology laboratory, i.e. red cell grouping, Rh typing and antibody screens | BK050028 | Greiner Bio-One North America, Inc 4238 Capital Drive Monroe, NC 28110 |
7/7/2005 |
| Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 | Blood Establishment Computer Software | BK050018 | GE Medical Information Technologies 540 Northwest Highway Barrington, IL 60010 |
6/13/2005 |
| BBCS Mobile Application 5.0M | Blood Establishment Computer Software | BK050013 | Blood Bank Computer Systems, Inc 1002 15th St SW Suite 120 Auburn, WA 98001-6502 |
6/1/2005 |
| Dynal RELI SSO HLA-DRB1 Typing Kit
(For use as a manual assay or with the AutoRELI 48 instrument) |
Typing System for PCR target amplification, hybridization of the amplified products to an array of immobilized sequence-specific oligonucleotide probes, and detection of the probe-bound amplified product by color formation | BK050012 | Dynal Biotech Ltd 11 Bassendale Road Croft Busines Park Bromborough, Wirral CH62 3QL United Kingdom |
5/18/2005 |
| LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell Filter for Red Blood Cells in additive solution | Leukoreduction of one unit of red blood cells in additive solution at ambient temperature | BK050020 | Baxter Healthcare Corp 1620 Waukegan Road McGaw Park, IL 60085 |
5/17/2005 |
| HCLL Donor 1.0 | Blood Establishment Computer Software | BK050011 | Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving TX 75038 |
5/10/2005 |
| VeriSure Pro External Quality Controls | Unassayed human plasma-based quality controls intended for use with the Procleix HIV-1/HCV assay for the detection of human immunodeficiency virus type 1 RNS and hepatitis C virus RNS in human plasma from donations of whole blood and blood components for transfusion | BK040060 | AcroMetrix Corp 6058 Egret Court Benicia, CA 94510 |
5/3/2005 |
| Procleix System | Intended for use as an integrated software / equipment system to be used in conjunction with blood screening assay developed and manufactured by Gen-Probe | BK050007 | Gen-Probe 10210 Genetic Center Drive San Diego, CA 92121-4362 |
4/29/2005 |
| ACP 215 Glycerolization/Deglycerolization System | Amend the current frozen storage temperature from -80 oC to -65 oC | BK050006 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
4/14/2005 |
| Leukotrap SC RC Filtration System | To be used for leukocyte reduction and storage of a single unit of packed red blood cells or whole blood | BK050015 | MEDSEP Corp 1630 Industrial Park St Covina, CA 91722 |
4/14/2005 |
| Procleix Optiva RAS | Intended for use in the licensed / registered Procleix Assays | BK050004 | Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 |
4/8/2005 |
| TSCD-II Terumo Sterile Tubing Welder | To provide a sterile weld between 2 pieces of polyvinyl Chloride (PVC) tubing in combinations of dry/dry, wet/dry, and wet/wet tubing | BK040082 | Terumo Medical Corp 125 Blue Ball Road Elkton, MD 21921 |
4/5/2005 |
| Tango Automated Blood Bank Analyzer System | Intended for use in ABO/Rh Blood Grouping determinations for patients and donors; independent confirmation of donor labeling; antibody screening for the detection of unexpected RBC alloantibodies | BK040070 | Olympus America Inc, Diagnostic Systems Division 3131 West Royal Lane Irving, TX 75063-3104 |
3/22/2005 |
| COBE Spectra Apheresis System & Trima Automated Blood Component Collection System | Change the recommended storage time of platelets collected with their apheresis systems from 5 to 7 days when tested for bacterial contamination using the bioMerieux BacT/ALERT Microbial Detection System | BK040086 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
3/15/2005 |
| ALYX Component Collection System | For the collection of Single Unit Red Blood Cells with Concurrent Plasma | BK040084 | Baxter Healthcare Corp 1620 Waukegan Road McGaw Park, IL 60085 |
3/15/2005 |
| BBCS Lab Interface Application (BBCS Lab) 5.0L | Blood Establishment Computer Software | BK040087 | Blood Bank Computer Systems, Inc 1002 15th St. SW, Suite 120 Auburn, WA 98001-6502 |
2/15/2005 |
| Sahara-TSC | To thaw and/or warm leukapheresis products from mobilized donors | BK040080 | Sarstedt, Inc P.O. Box 468 Newton, NC 28658-0468 |
2/9/2005 |
| Aldecount Progenitor Cell Enumeration Kit | For general diagnostic purposes to enumerate ALDHbright SSClo cells in fresh or frozen clinical samples from normal donors, donors mobilized with granulocyte colony stimulating factor (G-CSF) or some other mobilizing agent or patients that have been mobilized or treated with chemotherapeutic agents | BK040075 | Stemco Biomedical, Inc 2810 Meridian Parkway Suite 148 Durham, NC 27713 |
1/6/2005 |