Cleared Traditional

TESTOSTERONE TEST SYSTEM (K120009) - FDA 510(k) Clearance

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

Class I Chemistry device.

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

Submission Details

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.

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 35
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K120009.
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
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K152155 · Abbott Laboratories · Dec 2015
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K133491 · Siemens Healthcare Diagnostics, Inc. · Feb 2014
ELECYSYS SHBG
K102814 · Roche Diagnostics · Jan 2011
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · Roche Diagnostics Corp. · Apr 2010
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
K083867 · Beckman Coulter, Inc. · Aug 2009