• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

BK110002 Letter

December 12, 2011

Gen-Probe Transplant Diagnostics, Inc.
Attention: Ms. Susan L. Leary
550 West Avenue
Stanford, CT 06902

Re:BK110002
Product:LIFECODES HLA-A eRES Typing Kit for use with Luminex
LIFECODES HLA-B eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB1 eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB 3, 4, 5 Typing Kit for use with Luminex
Regulatory Class:Unclassified
Product Code:MZI
Dated:December 2, 2011
Received:December 2, 2011

Dear Ms. Leary:

This letter supersedes the December 2, 2011 letter. The device is unclassified therefore the regulation name is not applicable.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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, therefore, market the device, 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 device is classified (see above) into either Class II (Special Controls) or Class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device 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 device complies 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 807); labeling (21 CFR 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice on promotional labeling and advertisement for your device, 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" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 803), please go to: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 638-2041 or (301) 796-7100 or at its Internet address: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, 

/signature/

for
Richard J. Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research


Indications for Use

510(k) Number:BK110002
  
Device Name:LIFECODES HLA-A eRES Typing Kit for use with Luminex
LIFECODES HLA-B eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB1 eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB 3, 4, 5 Typing Kit for use with Luminex

Indications For Use:

LIFECODES HLA Typing Kits are qualitative tests (in vitro diagnostic kits) for the DNA typing of Class I and Class II HLA alleles. The products are used by trained professionals in medical setting for the purpose of determining HLA phenotype. The source of material tested is DNA. No component of the kit comes in direct contact with the patient. DNA typings are not the sole tests upon which a clinical decision affecting the patient is based; a cross-match is routinely required. These kits are intended for In Vitro Diagnostic (IVD) use.