FDA product code OAI: Assay, Enterovirus Nucleic Acid
OAI is the FDA product code for assay, enterovirus nucleic acid. It is a Class II device, regulated under 21 CFR 866.3225 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OAI. The average 510(k) review took 602 days (median 602). 1 De Novo request was granted under it.
Definition
Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Enterovirus Nucleic Acid |
| Device class | Class II |
| Regulation | 21 CFR 866.3225 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OAI clearance
Top OAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| bioMerieux, Inc. | 1 | 2008-06-23 |
Most recent OAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063261 | bioMerieux, Inc. | NUCLISENS EASYQ ENTEROVIRUS SYSTEM | 2008-06-23 | 602 |
Recalls for OAI devices
openFDA lists no recalls for product code OAI.
Frequently asked questions
What is FDA product code OAI?
OAI is the FDA product code for assay, enterovirus nucleic acid. It is a Class II device, regulated under 21 CFR 866.3225 and reviewed by the Microbiology panel.
What device class is OAI?
Class II, regulation 21 CFR 866.3225. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAI?
Across 1 cleared submissions the average was 602 days from receipt to decision (median 602).
Which companies have the most OAI clearances?
bioMerieux, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAI
- Run a recall and safety report across every OAI manufacturer
- Watch product code OAI 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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