K203757 is an FDA 510(k) clearance for the Elecsys AMH. This device is classified as a Anti-müllerian Hormone Test System (Class II - Special Controls, product code PQO).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 10, 2022, 534 days after receiving the submission on December 23, 2020.
This device falls under the Chemistry 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 | K203757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | June 10, 2022 |
| Days to Decision | 534 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| 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. |