Cleared Traditional

Elecsys AMH

K203757 · Roche Diagnostics · Chemistry
Jun 2022
Decision
534d
Days
Class 2
Risk

About This 510(k) Submission

K203757 is an FDA 510(k) clearance for the Elecsys AMH, a Anti-m�llerian Hormone Test System (Class II — Special Controls, product code PQO), submitted by Roche Diagnostics (Indianapolos, 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 review panel. Regulated under 21 CFR 862.1092.

Submission Details

510(k) Number K203757 FDA.gov
FDA Decision Cleared 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

Device Classification

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.