FDA product code PVQ: Rickettsia Spp. Nucleic Acid Based Detection Assay
PVQ is the FDA product code for rickettsia spp. nucleic acid based detection assay. It is a Class II device, regulated under 21 CFR 866.3316 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PVQ. The average 510(k) review took 91 days (median 91).
Definition
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.
Classification
| Field | Value |
|---|---|
| Device name | Rickettsia Spp. Nucleic Acid Based Detection Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3316 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PVQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 91 |
Compare with all 510(k) review times · Search every PVQ clearance
Top PVQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centers For Disease Control and Prevention (CDC) | 1 | 2017-06-29 |
Most recent PVQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170940 | Centers For Disease Control and Prevention (CDC) | Rickettsia Real-time PCR Assay | 2017-06-29 | 91 |
Recalls for PVQ devices
openFDA lists no recalls for product code PVQ.
Frequently asked questions
What is FDA product code PVQ?
PVQ is the FDA product code for rickettsia spp. nucleic acid based detection assay. It is a Class II device, regulated under 21 CFR 866.3316 and reviewed by the Microbiology panel.
What device class is PVQ?
Class II, regulation 21 CFR 866.3316. Typical premarket route: 510(k).
How long does a 510(k) take for product code PVQ?
Across 1 cleared submissions the average was 91 days from receipt to decision (median 91).
Which companies have the most PVQ clearances?
Centers For Disease Control and Prevention (CDC) (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PVQ
- Run a recall and safety report across every PVQ manufacturer
- Watch product code PVQ 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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