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U.S. Department of Health and Human Services

Product Classification

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Device thermocycler, generic
Regulation Description Clinical sample concentrator.
Definition A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process.The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run.It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats.
Physical State Should not include real-time thermocyclers or instruments with analyzers for fluorescence, other measuring techniques, or detection methods or integrate sample and/or reagent handling.
Technical Method A thermocycler is intended amplify specific sequences of double stranded nucleic acids using the polymerase chain process. The device includes a thermal block with holes designed to accommodate the insertion of special tubes or plates holding the assay reaction mixtures and houses an internal computer-controlled, rapid heating/cooling unit. The thermal block¿s temperature is raised and lowered at specific rates using pre-programmed steps based on the specifications of the test which is being run.
Target Area Not applicable
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOUL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2310
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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