March 27, 2012
Siemens Healthcare Diagnostics, Inc.
Attention: Ms. Allison Gannon, RAC
P.O. Box 2466
Berkeley, CA 94702
Trade/Device Name: TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System
Classification Name: Software, Blood Virus Application
Regulatory Class: Class II
Product Code: MTQ
Dated: March 1, 2012
Received: March 2, 2012
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 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 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" (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.
Hira L. Nakhasi, Ph.D.
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: BK120013
Device Name: TRUEGENE® 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.