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U.S. Department of Health and Human Services

Product Classification

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Device assay, direct, nucleic acid amplification, q fever
Regulation Description Rickettsia serological reagents.
Definition These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.
Physical State A kit that contains reagents and an instrument that measures flourescence.
Technical Method The Q Fever assay uses a real-time thermocycler. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
Target Area Blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOVF
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3500
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible