FDA product code PQO: Anti-Müllerian Hormone Test System
PQO is the FDA product code for anti-müllerian hormone test system. It is a Class II device, regulated under 21 CFR 862.1092 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under PQO, 3 in the last five years, from 3 different applicants. The average 510(k) review took 300 days (median 305). 1 De Novo request was granted under it. FDA has posted 1 recall for PQO devices, 1 initiated in the last five years.
Definition
An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Müllerian Hormone Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1092 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for PQO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 264 |
| 2022 | 1 | 534 |
| 2023 | 2 | 202 |
Compare with all 510(k) review times · Search every PQO clearance
Top PQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 2023-02-03 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2023-06-02 |
| Roche Diagnostics | 1 | 2022-06-10 |
Most recent PQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221801 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | 2023-06-02 | 346 |
| K223679 | Beckman Coulter, Inc. | Access AMH | 2023-02-03 | 57 |
| K203757 | Roche Diagnostics | Elecsys AMH | 2022-06-10 | 534 |
| K170524 | Beckman Coulter, Inc. | Access AMH | 2017-11-13 | 264 |
Recalls for PQO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code PQO?
PQO is the FDA product code for anti-müllerian hormone test system. It is a Class II device, regulated under 21 CFR 862.1092 and reviewed by the Clinical Toxicology panel.
What device class is PQO?
Class II, regulation 21 CFR 862.1092. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQO?
Across 4 cleared submissions the average was 300 days from receipt to decision (median 305).
Which companies have the most PQO clearances?
Beckman Coulter, Inc. (2); Siemens Healthcare Diagnostics, Inc. (1); Roche Diagnostics (1).
Have PQO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PQO
- Run a recall and safety report across every PQO manufacturer
- Watch product code PQO 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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