Cleared Traditional

K120009 - TESTOSTERONE TEST SYSTEM

Also marketed or referenced as:
CALIBRATOR AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)

K120009 is an FDA 510(k) clearance for TESTOSTERONE TEST SYSTEM, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K120009 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
252d
Days
Class 1
Risk

K120009 is an FDA 510(k) clearance for the TESTOSTERONE TEST SYSTEM. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 11, 2012 after a review of 252 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K120009

510(k) Number K120009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date September 11, 2012
Days to Decision 252 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
164d slower than avg
Panel avg: 88d · This submission: 252d
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 56
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K120009.
ARCHITECT 2nd Generation Testosterone
K152155 · Abbott Laboratories · Dec 2015
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · Siemens Healthcare Diagnostics, Inc. · Feb 2014
LIAISON TESTOSTERONE
K122793 · DiaSorin, Inc. · Jan 2013
ELECYSYS SHBG
K102814 · Roche Diagnostics · Jan 2011
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · Roche Diagnostics Corp. · Apr 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
K091867 · Siemens Healthcare Diagnostics · Jan 2010