Cleared Traditional

K211685 - Elecsys Testosterone II (FDA 510(k) Clearance)

Class I Chemistry device.

K211685 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
338d
Days
Class 1
Risk

K211685 is an FDA 510(k) clearance for the Elecsys Testosterone II. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 6, 2022 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K211685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2021
Decision Date May 06, 2022
Days to Decision 338 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
250d slower than avg
Panel avg: 88d · This submission: 338d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.