FDA product code OMM: Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
OMM is the FDA product code for test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr. It is a Class II device, regulated under 21 CFR 864.7280 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under OMM. The average 510(k) review took 413 days (median 413).
Definition
In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.
Classification
| Field | Value |
|---|---|
| Device name | Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr |
| Device class | Class II |
| Regulation | 21 CFR 864.7280 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OMM clearance
Top OMM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hologic, Inc. | 2 | 2011-05-13 |
Most recent OMM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100987 | Hologic, Inc. | INVADER MTHFR 677 | 2011-05-13 | 399 |
| K100496 | Hologic, Inc. | INVADER MTHFR 1298 | 2011-04-25 | 427 |
Recalls for OMM devices
openFDA lists no recalls for product code OMM.
Frequently asked questions
What is FDA product code OMM?
OMM is the FDA product code for test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr. It is a Class II device, regulated under 21 CFR 864.7280 and reviewed by the Hematology panel.
What device class is OMM?
Class II, regulation 21 CFR 864.7280. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMM?
Across 2 cleared submissions the average was 413 days from receipt to decision (median 413).
Which companies have the most OMM clearances?
Hologic, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OMM
- Run a recall and safety report across every OMM manufacturer
- Watch product code OMM 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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