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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK110007 Letter

March 4, 2011

Siemens Healthcare Diagnostics Inc.
Attention: Ms. Allison Gannon
P.O. Box 2466
Berkeley, CA 94702

Re:
Trade/Device Name:
Product Name:
Regulatory Class:
Product Code:
Dated:
Received:
BK110007
TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System
Software, Blood Virus Application
Class II
MTQ
February 2, 2011
February 4, 2011

Dear Ms. Gannon:

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 for your device on our labeling regulation (21 CFR 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 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 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


Indications for Use

510(k) Number:
Device Name:
BK110007
TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System

Indications For Use:

The TRUGENE HIV-1 Genotyping Kit and the OpenGene DNA Sequencing System are indicated for use in detecting HIV genomic mutations in the protease and part of the reverse transcriptase region of HIV that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. The TRUGENE HIV-1 Genotyping Kit and the OpenGene DNA Sequencing System may be used to genotype the protease region (PR) of the pol gene from codons 10 – 99, and the reverse transcriptase (RT) region of the pol gene from codons 41 – 142 and 148 - 247. These two regions code for the main targets of antiretroviral drug treatment. Development of viral resistance to these drugs is associated with mutations within these coding regions. The mutations are identified by sequencing an RT-PCR product corresponding to these regions, and comparing the sequence to a wild type virus reference standard. This qualitative assay is used in conjunction with clinical presentation, laboratory markers and antiretroviral history as an adjunct to the therapeutic management of patients with HIV-1 subtype B infection, and a minimum viral load of 1000 RNA copies per mL.

The TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System are not indicated for use as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.