FDA product code MQA: Anti-Ribosomal P Antibodies
MQA is the FDA product code for anti-ribosomal p antibodies. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under MQA, from 4 different applicants. The average 510(k) review took 248 days (median 220).
Classification
| Field | Value |
|---|---|
| Device name | Anti-Ribosomal P Antibodies |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MQA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 376 |
Compare with all 510(k) review times · Search every MQA clearance
Top MQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phadia AB | 1 | 2021-09-13 |
| Theratest Laboratories, Inc. | 1 | 2003-02-06 |
| Inova Diagnostics, Inc. | 1 | 1998-06-05 |
| Hogan & Hartson | 1 | 1996-05-23 |
Most recent MQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202540 | Phadia AB | EliA Rib-P | 2021-09-13 | 376 |
| K024151 | Theratest Laboratories, Inc. | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | 2003-02-06 | 62 |
| K981237 | Inova Diagnostics, Inc. | QUANTA LITE RIBOSOME P ELISA | 1998-06-05 | 63 |
| K950169 | Hogan & Hartson | RIBOSOMAL P EIA TEST SYSTEM | 1996-05-23 | 492 |
Recalls for MQA devices
openFDA lists no recalls for product code MQA.
Frequently asked questions
What is FDA product code MQA?
MQA is the FDA product code for anti-ribosomal p antibodies. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is MQA?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQA?
Across 4 cleared submissions the average was 248 days from receipt to decision (median 220).
Which companies have the most MQA clearances?
Phadia AB (1); Theratest Laboratories, Inc. (1); Inova Diagnostics, Inc. (1); Hogan & Hartson (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MQA
- Run a recall and safety report across every MQA manufacturer
- Watch product code MQA 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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