K221801 is an FDA 510(k) clearance for the ADVIA Centaur® Anti-Müllerian Hormone (AMH). This device is classified as a Anti-müllerian Hormone Test System (Class II - Special Controls, product code PQO).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on June 2, 2023, 346 days after receiving the submission on June 21, 2022.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1092. 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..
| 510(k) Number | K221801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2022 |
| Decision Date | June 02, 2023 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | PQO — Anti-müllerian Hormone Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1092 |
| 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. |