Cleared Traditional

K122793 - LIAISON TESTOSTERONE

Also marketed or referenced as:
LIAISON TESTOSTERONE CONTROL SET

K122793 is an FDA 510(k) clearance for LIAISON TESTOSTERONE, manufactured by DiaSorin, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K122793

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.

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
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K122793.
ARCHITECT 2nd Generation Testosterone
K152155 · Abbott Laboratories · Dec 2015
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
K143075 · Tosoh Bioscience, Inc. · Jul 2015
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · Siemens Healthcare Diagnostics, Inc. · Feb 2014
TESTOSTERONE TEST SYSTEM
K120009 · Abbott Laboratories · Sep 2012
ELECYSYS SHBG
K102814 · Roche Diagnostics · Jan 2011
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · Roche Diagnostics Corp. · Apr 2010