FDA product code OEP: Influenza A Virus Subtype Differentiation Nucleic Acid Assay
OEP is the FDA product code for influenza a virus subtype differentiation nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OEP. The average 510(k) review took 22 days (median 22).
Definition
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.
Classification
| Field | Value |
|---|---|
| Device name | Influenza A Virus Subtype Differentiation Nucleic Acid Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3980 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OEP clearance
Top OEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centers for Disease Control and Prevention | 1 | 2014-04-25 |
Most recent OEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140851 | Centers for Disease Control and Prevention | INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | 2014-04-25 | 22 |
Recalls for OEP devices
openFDA lists no recalls for product code OEP.
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
Frequently asked questions
What is FDA product code OEP?
OEP is the FDA product code for influenza a virus subtype differentiation nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OEP?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEP?
Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most OEP clearances?
Centers for Disease Control and Prevention (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OEP
- Run a recall and safety report across every OEP manufacturer
- Watch product code OEP 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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