OTA

Mass Spectrometer For Clinical Multiplex Test Systems

Product code

OTA

Device name

Mass Spectrometer For Clinical Multiplex Test Systems

Device class

Class 2

21 CFR

21 CFR 862.2570

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

FDA classification definition

A mass spectrometer 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 are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature.

Definition text from the FDA device classification database (U.S. federal government work, public domain).