Cleared Traditional

K132249 - ADVIA CENTAUR FT4

K132249 is the FDA 510(k) clearance for ADVIA CENTAUR FT4 by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K132249 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Sep 2013
Decision
56d
Days
Class 2
Risk

K132249 is an FDA 510(k) clearance for the ADVIA CENTAUR FT4, ADVIA CENTAUR T4. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 13, 2013 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K132249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2013
Decision Date September 13, 2013
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 63
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K132249.
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
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K140859 · Siemens Healthcare Diagnostics, Inc. · Nov 2014
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K131244 · Roche Diagnostics · Jan 2014
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
K121951 · DiaSorin, Inc. · Apr 2013
ABBOTT ARCHITECT FREE T4
K123379 · Abbott Laboratories · Nov 2012
IMMULITE 2000 FREE T4
K083373 · Siemens Healthcare Diagnostics, Inc. · Feb 2009