FDA product code PQA: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
PQA is the FDA product code for vaginitis and bacterial vaginosis nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3975 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under PQA, 7 in the last five years, from 6 different applicants. The average 510(k) review took 141 days (median 90); 107 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for PQA devices.
Definition
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
Classification
| Field | Value |
|---|---|
| Device name | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.3975 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PQA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 3 | 85 |
| 2021 | 1 | 549 |
| 2022 | 2 | 128 |
| 2023 | 2 | 125 |
| 2024 | 2 | 22 |
| 2026 | 1 | 192 |
Compare with all 510(k) review times · Search every PQA clearance
Top PQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hologic, Inc. | 3 | 2024-11-25 |
| Cepheid | 3 | 2023-10-19 |
| Becton, Dickinson and Company | 2 | 2024-12-19 |
| Roche Molecular Systems, Inc. | 1 | 2026-07-16 |
| Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 1 | 2021-10-18 |
1 more applicants have PQA clearances. See the full list in Caduvo.
Most recent PQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260021 | Roche Molecular Systems, Inc. | cobas® BV/CV | 2026-07-16 | 192 |
| K243725 | Becton, Dickinson and Company | BD Vaginal Panel | 2024-12-19 | 16 |
| K243345 | Hologic, Inc. | Aptima BV Assay; Aptima CV/TV Assay | 2024-11-25 | 28 |
| K231381 | Cepheid | Xpert Xpress MVP; GeneXpert Xpress System | 2023-10-19 | 160 |
| K223653 | Becton, Dickinson and Company | BD Vaginal Panel | 2023-03-06 | 90 |
Recalls for PQA devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-07-17.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code PQA?
PQA is the FDA product code for vaginitis and bacterial vaginosis nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3975 and reviewed by the Microbiology panel.
What device class is PQA?
Class II, regulation 21 CFR 866.3975. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQA?
Across 11 cleared submissions the average was 141 days from receipt to decision (median 90).
Which companies have the most PQA clearances?
Hologic, Inc. (3); Cepheid (3); Becton, Dickinson and Company (2); Roche Molecular Systems, Inc. (1); Geneohm Sciences Canada, Inc. (Bd Life Sciences) (1).
Have PQA devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2019-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code PQA
- Run a recall and safety report across every PQA manufacturer
- Watch product code PQA 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times