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U.S. Department of Health and Human Services

Product Classification

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Device instrumentation for clinical multiplex test systems
Regulation Description Instrumentation for clinical multiplex test systems.
Definition Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample.The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties.The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNSU
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
Guidance Document
  • Instrumentation for Clinical Multiplex Test Systems - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible