Cleared Traditional

K152155 - ARCHITECT 2nd Generation Testosterone

K152155 is an FDA 510(k) clearance for ARCHITECT 2nd Generation Testosterone, 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 136-day FDA review.

K152155 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
136d
Days
Class 1
Risk

K152155 is an FDA 510(k) clearance for the ARCHITECT 2nd Generation Testosterone. 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 December 17, 2015 after a review of 136 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K152155

510(k) Number K152155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date December 17, 2015
Days to Decision 136 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 88d · This submission: 136d
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 K152155.
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
K151986 · Siemens Healthcare Diagnostics, Inc. · Jun 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
K151529 · Siemens Healthcare Diagnostics, Inc. · Feb 2016
ARCHITECT SHBG
K152185 · Biokit, S.A. · Feb 2016
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · Siemens Healthcare Diagnostics, Inc. · Feb 2014
LIAISON TESTOSTERONE
K122793 · DiaSorin, Inc. · Jan 2013
TESTOSTERONE TEST SYSTEM
K120009 · Abbott Laboratories · Sep 2012