Substantially Equivalent 510(k) Device Information
July 23, 2008
Biotest Diagnostics Corp.
Attention: Mr. William Weiss
400 Commons Way, Suite F
Rockaway, NJ 07866
| Re: | BK080013 |
| Product: | 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 |
| Date Received: | 17-MAR-08 |
| Classification: | II |
| Device Code: | KSG, KSF, KSF, KSZ (respectively) |
Dear Mr. Weiss:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may not market these devices, however, until such time as the biologics license applications (BL 125202/0, 125203/0, 125204/0, 125205/0, 125206/0, 125208/0, and 125218/0) and supplements (BL 125097/10 and 125098/8) for reagents for use on the Tango Optimo Automated Blood Bank Analyzer are licensed and approved by the Center for Biologics Evaluation and Research. When the devices are marketed, they will be subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. However, you are responsible for determining that the biologics products you use as reagents for the Tango Optimo Automated Blood Bank Analyzer have been licensed and approved.
If your devices have been classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice on promotional labeling and advertisement for your devices, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 835-4709 or (301) 827-1800 or at its Internet address: http://www.fda.gov/cber/smlbus.htm.
Sincerely yours,
/Elizabeth Callaghan/
Elizabeth Callaghan
Acting Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Indications for Use
510(k) Number (if known): BK080013
Device Name: TANGO OPTIMO* AUTOMATED ANALYZER SYSTEM
* formerly known as "TANGO AUTOMATED ANALYZER SYSTEM"
Indications For Use:
Intended for use in ABO, Rh(D) (including weak D testing) and Rh Phenotype and Kell blood grouping for patient and donor testing, including on receipt, independent confirmation of donor unit labeling. The TANGO OPTIMO Automated Blood Bank Analyzer System uses Anti-Human Globulin Anti-IgG Solidscreen II to detect human red blood cells sensitized with IgG alloantibodies and/or autoantibodies to include tests for antibody screening, antibody identification, crossmatching (compatibility testing) and the Direct Antiglobulin Test. Also, Blood Grouping Reagent Solidscreen II Anti-D is used to detect weak D and partial D (DVI and DVII) antigens.
The TANGO OPTIMO automated system utilizes Blood Grouping Reagents and Anti-Human Globulin Reagents specifically formulated and manufactured by or for Biotest Medical Diagnostics GmbH, and licensed and cleared exclusively for this system.