FDA product code JQA: Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
JQA is the FDA product code for electrophoretic, gamma-glutamyl transpeptidase isoenzymes. It is a Class I device, regulated under 21 CFR 862.1360 and reviewed by the Clinical Chemistry panel. Devices under JQA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for JQA devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes |
| Device class | Class I |
| Regulation | 21 CFR 862.1360 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JQA devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2020-11-23.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code JQA?
JQA is the FDA product code for electrophoretic, gamma-glutamyl transpeptidase isoenzymes. It is a Class I device, regulated under 21 CFR 862.1360 and reviewed by the Clinical Chemistry panel.
What device class is JQA?
Class I, regulation 21 CFR 862.1360. Typical premarket route: 510(k) exempt.
Have JQA devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2020-11-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JQA
- Run a recall and safety report across every JQA manufacturer
- Watch product code JQA 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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