FDA product code OVF: Assay, Direct, Nucleic Acid Amplification, Q Fever
OVF is the FDA product code for assay, direct, nucleic acid amplification, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OVF. The average 510(k) review took 200 days (median 200).
Definition
These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Direct, Nucleic Acid Amplification, Q Fever |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OVF clearance
Top OVF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Idaho Technology, Inc. | 1 | 2011-05-20 |
Most recent OVF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K103207 | Idaho Technology, Inc. | JBAIDS Q FEVER DETECTION KIT | 2011-05-20 | 200 |
Recalls for OVF devices
openFDA lists no recalls for product code OVF.
Frequently asked questions
What is FDA product code OVF?
OVF is the FDA product code for assay, direct, nucleic acid amplification, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is OVF?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVF?
Across 1 cleared submissions the average was 200 days from receipt to decision (median 200).
Which companies have the most OVF clearances?
Idaho Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OVF
- Run a recall and safety report across every OVF manufacturer
- Watch product code OVF 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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