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U.S. Department of Health and Human Services

Product Classification

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Device real time nucleic acid amplification system
Regulation Description Instrumentation for clinical multiplex test systems.
Definition The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample.Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector.It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.The system is used with specific assays to comprise an assay test system.
Physical State Should not include microarray or electrophoresis detection methods or instruments.
Technical Method 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 N/A
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOOI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible