Cleared Traditional

ADVIA CENTAUR TESTOSTERONE (TSTO) (K133491) - FDA 510(k) Clearance

Class I Chemistry device.

K133491 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
100d
Days
Class 1
Risk

K133491 is an FDA 510(k) clearance for the ADVIA CENTAUR TESTOSTERONE (TSTO). Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on February 21, 2014 after a review of 100 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K133491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2013
Decision Date February 21, 2014
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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 36
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K133491.
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 2nd Generation Testosterone
K152155 · Abbott Laboratories · Dec 2015
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