FDA product code PQZ: Gbs Culture Media, Selective And Differential
PQZ is the FDA product code for gbs culture media, selective and differential. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under PQZ, from 2 different applicants. The average 510(k) review took 88 days (median 88). FDA has posted 3 recalls for PQZ devices, 1 initiated in the last five years.
Definition
Culture Medium for GBS Detection
Classification
| Field | Value |
|---|---|
| Device name | Gbs Culture Media, Selective And Differential |
| Device class | Class I |
| Regulation | 21 CFR 866.2360 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PQZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 87 |
| 2018 | 1 | 90 |
Compare with all 510(k) review times · Search every PQZ clearance
Top PQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Diagnostics | 3 | 2018-03-22 |
| bioMerieux, Inc. | 1 | 2017-01-27 |
Most recent PQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173903 | Hardy Diagnostics | Granada Medium | 2018-03-22 | 90 |
| K170586 | Hardy Diagnostics | Strep B Carrot Broth One-Step | 2017-05-22 | 83 |
| K170481 | Hardy Diagnostics | Strep B Carrot Broth Kit | 2017-05-16 | 89 |
| K163042 | bioMerieux, Inc. | chromID Strepto B agar | 2017-01-27 | 88 |
Recalls for PQZ devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code PQZ?
PQZ is the FDA product code for gbs culture media, selective and differential. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel.
What device class is PQZ?
Class I, regulation 21 CFR 866.2360. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQZ?
Across 4 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most PQZ clearances?
Hardy Diagnostics (3); bioMerieux, Inc. (1).
Have PQZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code PQZ
- Run a recall and safety report across every PQZ manufacturer
- Watch product code PQZ 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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