• 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

BK100040 Letter

Ortho-Clinical Diagnostics, Inc.
Attention: Mr. Bradley P. Boyer
100 Indigo Creek Drive
Rochester, NY 14626-5101

Re:
Trade/Device Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Dated:
Received:
BK100040
VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls
21 CFR 862.1660
Quality control material (assayed and unassayed)
Class I
OHQ
June 17, 2010
June 21, 2010

Dear Mr. Boyer:

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 has been classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 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/

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and
Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics
Evaluation and Research

Enclosure


Indications for Use

510(k) Number: BK100040
Device Name: VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls for use with the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System
Indications for Use:
  For in vitro diagnostic use only.
For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VTIROS 5600 Integrated System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV-1 and anti-HIV-2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integratged System. The performance of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls has not been established with any other anti-HIV- 1+2 assays.