510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OTAClass II

Mass Spectrometer For Clinical Multiplex Test Systems

21 CFR 862.2570 / Clinical Chemistry
FDA source (opens on fda.gov)

OTA is the FDA product code for Mass Spectrometer For Clinical Multiplex Test Systems, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OTA
Device name
Mass Spectrometer For Clinical Multiplex Test Systems
FDA 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.
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code