FDA product code OTA: Mass Spectrometer For Clinical Multiplex Test Systems
OTA is the FDA product code for mass spectrometer for clinical multiplex test systems. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel. Devices under OTA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OTA devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Mass Spectrometer For Clinical Multiplex Test Systems |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for OTA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-16.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code OTA?
OTA is the FDA product code for mass spectrometer for clinical multiplex test systems. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel.
What device class is OTA?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
Have OTA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-04-16.
Next steps
- Run an FDA pathway report with predicate devices for product code OTA
- Run a recall and safety report across every OTA manufacturer
- Watch product code OTA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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