Cleared Traditional

K093421 - ELECSYS TESTOSTERONE II IMMUNOASSAY

K093421 is an FDA 510(k) clearance for ELECSYS TESTOSTERONE II IMMUNOASSAY, manufactured by Roche Diagnostics Corp.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K093421 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
171d
Days
Class 1
Risk

K093421 is an FDA 510(k) clearance for the ELECSYS TESTOSTERONE II IMMUNOASSAY. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 23, 2010 after a review of 171 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K093421

510(k) Number K093421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2009
Decision Date April 23, 2010
Days to Decision 171 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
83d slower than avg
Panel avg: 88d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 65
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