DEN150057 is an FDA 510(k) submission for the Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5. 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 Not Cleared (DENG) decision on December 19, 2016.
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 | DEN150057 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 09, 2015 |
| Decision Date | December 19, 2016 |
| Days to Decision | 376 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| 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. |