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, Siemens Healthcare Diagnostics, Inc. and Beckman Coulter, Inc..
List of Anti-müllerian Hormone Test System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Anti-müllerian Hormone Test System devices (product code PQO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →