FDA product code MVM: Autoantibodies, Endomysial(Tissue Transglutaminase)
MVM is the FDA product code for autoantibodies, endomysial(tissue transglutaminase). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 40 510(k) submissions under MVM, from 18 different applicants. The average 510(k) review took 156 days (median 120). FDA has posted 1 recall for MVM devices.
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Endomysial(Tissue Transglutaminase) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MVM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 162 |
| 2021 | 2 | 558 |
Compare with all 510(k) review times · Search every MVM clearance
Top MVM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 12 | 2021-08-26 |
| Immco Diagnostics, Inc. | 6 | 2013-10-25 |
| Scimedx Corp. | 3 | 2001-04-24 |
| Phadia US, Inc. | 2 | 2006-12-29 |
| Hycor Biomedical , Ltd. | 2 | 2005-03-07 |
13 more applicants have MVM clearances. See the full list in Caduvo.
Most recent MVM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200230 | Inova Diagnostics, Inc. | Aptiva Celiac Disease IgG Reagent | 2021-08-26 | 574 |
| K193604 | Inova Diagnostics, Inc. | Aptiva Celiac Disease IgA Reagent | 2021-06-16 | 541 |
| K181871 | Phadia AB | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | 2019-03-01 | 232 |
| K183313 | Euroimmun Us, Inc. | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | 2019-02-28 | 91 |
| K140691 | Sqi Diagnostics Systems, Inc. | IG_PLEX CELIAC DGP PANEL | 2014-11-06 | 232 |
Recalls for MVM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code MVM?
MVM is the FDA product code for autoantibodies, endomysial(tissue transglutaminase). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is MVM?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVM?
Across 40 cleared submissions the average was 156 days from receipt to decision (median 120).
Which companies have the most MVM clearances?
Inova Diagnostics, Inc. (12); Immco Diagnostics, Inc. (6); Scimedx Corp. (3); Phadia US, Inc. (2); Hycor Biomedical , Ltd. (2).
Have MVM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MVM
- Run a recall and safety report across every MVM manufacturer
- Watch product code MVM 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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