Cleared Traditional

K122793 - LIAISON TESTOSTERONE

Also marketed or referenced as:
LIAISON TESTOSTERONE CONTROL SET

K122793 is the FDA 510(k) clearance for LIAISON TESTOSTERONE by DiaSorin, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K122793 · DiaSorin, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
135d
Days
Class 1
Risk

K122793 is an FDA 510(k) clearance for the LIAISON TESTOSTERONE. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 135 days - within the typical 510(k) review window.

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 DiaSorin, Inc. devices

Submission Details

510(k) Number K122793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2012
Decision Date January 25, 2013
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
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.

Regulatory Peers - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 47
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