FDA product code MST: Antibodies, Gliadin
MST is the FDA product code for antibodies, gliadin. It is a Class II device, regulated under 21 CFR 866.5750 and reviewed by the Immunology panel. FDA has cleared 42 510(k) submissions under MST, from 18 different applicants. The average 510(k) review took 141 days (median 104). FDA has posted 3 recalls for MST devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antibodies, Gliadin |
| Device class | Class II |
| Regulation | 21 CFR 866.5750 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MST
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 256 |
Compare with all 510(k) review times · Search every MST clearance
Top MST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 8 | 2012-09-20 |
| Immco Diagnostics, Inc. | 4 | 2017-07-28 |
| Zeus Scientific, Inc. | 4 | 2000-06-07 |
| The Binding Site, Ltd. | 3 | 2008-10-15 |
| Aesku Diagnostics | 2 | 2013-12-05 |
13 more applicants have MST clearances. See the full list in Caduvo.
Most recent MST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163177 | Immco Diagnostics, Inc. | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | 2017-07-28 | 256 |
| K132082 | Aesku Diagnostics | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | 2013-12-05 | 153 |
| K113377 | Grifols USA, LLC | GLIADIN IGA AND GLIADIN LGA | 2012-12-14 | 394 |
| K113863 | Inova Diagnostics, Inc. | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS | 2012-09-20 | 265 |
| K111414 | Inova Diagnostics, Inc. | QUANTA FLASH (TM) DGP SCREEN | 2011-10-20 | 153 |
Recalls for MST devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-05-01.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code MST?
MST is the FDA product code for antibodies, gliadin. It is a Class II device, regulated under 21 CFR 866.5750 and reviewed by the Immunology panel.
What device class is MST?
Class II, regulation 21 CFR 866.5750. Typical premarket route: 510(k).
How long does a 510(k) take for product code MST?
Across 42 cleared submissions the average was 141 days from receipt to decision (median 104).
Which companies have the most MST clearances?
Inova Diagnostics, Inc. (8); Immco Diagnostics, Inc. (4); Zeus Scientific, Inc. (4); The Binding Site, Ltd. (3); Aesku Diagnostics (2).
Have MST devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2023-05-01.
Next steps
- Run an FDA pathway report with predicate devices for product code MST
- Run a recall and safety report across every MST manufacturer
- Watch product code MST 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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