FDA product code OMS: Novel Influenza A Virus, A/H5 Ns1 Protein
OMS is the FDA product code for novel influenza a virus, a/h5 ns1 protein. It is a Class II device, regulated under 21 CFR 866.3332 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OMS. The average 510(k) review took 152 days (median 152).
Definition
Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza.
Classification
| Field | Value |
|---|---|
| Device name | Novel Influenza A Virus, A/H5 Ns1 Protein |
| Device class | Class II |
| Regulation | 21 CFR 866.3332 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OMS clearance
Top OMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arbor Vita Corportation | 1 | 2009-04-08 |
Most recent OMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083278 | Arbor Vita Corportation | AVC A/H5N1 FLU TEST | 2009-04-08 | 152 |
Recalls for OMS devices
openFDA lists no recalls for product code OMS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0008 — Administration of influenza virus vaccine
- Q2039 — Influenza virus vaccine, not otherwise specified
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu)
Frequently asked questions
What is FDA product code OMS?
OMS is the FDA product code for novel influenza a virus, a/h5 ns1 protein. It is a Class II device, regulated under 21 CFR 866.3332 and reviewed by the Microbiology panel.
What device class is OMS?
Class II, regulation 21 CFR 866.3332. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMS?
Across 1 cleared submissions the average was 152 days from receipt to decision (median 152).
Which companies have the most OMS clearances?
Arbor Vita Corportation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMS
- Run a recall and safety report across every OMS manufacturer
- Watch product code OMS 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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