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: | BK080012 |
| Product: | (1) Seraclone Control ABO+Rh (2) Coombscell-E (3) MLB2 |
| Date Received: | 17-MAR-08 |
| Classification: | II |
| Device Code: | KSF, KSF, KSG (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 (125207/0, 125212/0, 125213/0, 125214/0, 125215/0, 125216/0, 125217/0, 125218/0, 125219/0, 125220/0, 125221/0, 125222/0, 125223/0, 125224/0, 125225/0, 125226/0, 125227/0, 125228/0, 125229/0, 125230/0, 125231/0, 125232/0, 125233/0, and 125242/0) are licensed and approved by the Center for Biologics Evaluation and Research. However, you are responsible for determining that the Blood Grouping Reagents, Reagent Red Blood Cells, and Anti-Human Globulin for use in manual tube tests along with these reagents have been licensed and approved.
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.
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
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