PQO — Anti-Müllerian Hormone Test System Class II
FDA product code PQO covers "Anti-Müllerian Hormone Test System", a Class II medical device regulated under 21 CFR 862.1092. Submissions are reviewed by the Clinical Chemistry panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQO
- Device Class
- Class II
- Regulation Number
- 862.1092
- Submission Type
- 510(k)
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221801 | Siemens Healthcare Diagnostics | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Jun 2, 2023 |
| K223679 | Beckman Coulter | Access AMH | Feb 3, 2023 |
| K203757 | Roche Diagnostics | Elecsys AMH | Jun 10, 2022 |
| K170524 | Beckman Coulter | Access AMH | Nov 13, 2017 |
| DEN150057 | Roche Diagnostics | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Dec 19, 2016 |