Cleared Traditional

K133491 - ADVIA CENTAUR TESTOSTERONE (TSTO) (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
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 88
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K133491.
IDS-iSYS Total Testosterone
K252728 · Immunodiagnostic Systems Limited · Apr 2026
IDS-iSYS Free Testosterone
K240865 · Immunodiagnostic Systems Limited · Oct 2024
Access SHBG
K233480 · Beckman Coulter, Inc. · Feb 2024
Access Testosterone
K223405 · Beckman Coulter, Inc. · Jan 2023
Elecsys Testosterone II
K211685 · Roche Diagnostics · May 2022
LIAISON Testosterone xt
K201908 · DiaSorin, Inc. · Oct 2020