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..
FDA 510(k) Cleared Anti-müllerian Hormone Test System Devices (Product Code PQO)
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 3 in the prior period.
PQO devices are reviewed by the Chemistry panel. Browse all Chemistry devices →