FDA Product Code PQO: Anti-müllerian Hormone Test System
Anti-Müllerian hormone testing provides a direct measure of ovarian reserve. FDA product code PQO covers anti-Müllerian hormone test systems used in reproductive endocrinology.
These immunoassays measure AMH — a glycoprotein secreted by granulosa cells of preantral and antral follicles — in serum, providing an assessment of the remaining follicular pool. AMH is used to evaluate ovarian reserve in infertility patients and predict response to ovarian stimulation.
PQO devices are Class II medical devices, regulated under 21 CFR 862.1092 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Roche Diagnostics, Beckman Coulter, Inc. and Siemens Healthcare Diagnostics, Inc..
5
Total
4
Cleared
315d
Avg days
2016
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Anti-müllerian Hormone Test System Devices (Product Code PQO)
5 devices
Cleared
Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
Siemens Healthcare Diagnostics, Inc.
Toxicology
346d
Cleared
Feb 03, 2023
Access AMH
Beckman Coulter, Inc.
Chemistry
57d
Cleared
Jun 10, 2022
Elecsys AMH
Roche Diagnostics
Chemistry
534d
Cleared
Nov 13, 2017
Access AMH
Beckman Coulter, Inc.
Chemistry
264d
Not Cleared
Dec 19, 2016
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
Roche Diagnostics
Chemistry
376d
About Product Code PQO - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code PQO since 2016, with 4 receiving FDA clearance (average review time: 315 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.