Cleared Traditional

K203757 - Elecsys AMH (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K203757 is an FDA 510(k) clearance for the Elecsys AMH. Classified as Anti-müllerian Hormone Test System (product code PQO), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 10, 2022 after a review of 534 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1092 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

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Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
446d slower than avg
Panel avg: 88d · This submission: 534d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PQO Anti-müllerian Hormone Test System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.