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U.S. Department of Health and Human Services

Product Classification

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Device mass spectrometer for clinical multiplex test systems
Regulation Description Instrumentation for clinical multiplex test systems.
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.
Physical State mass spectrometer
Technical Method Multiplex mass spectrometer. The device may integrate sample preprocessing/work station, liquid or gas chromatography, raw data storage mechanisms and other essential hardware and software components along with the basic modules of a mass spectrometry instrument.
Target Area IVD
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOTA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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