OTA — Mass Spectrometer For Clinical Multiplex Test Systems Class II
FDA product code OTA covers "Mass Spectrometer For Clinical Multiplex Test Systems", a Class II medical device regulated under 21 CFR 862.2570. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- OTA
- Device Class
- Class II
- Regulation Number
- 862.2570
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.