Cleared Traditional

K131244 - ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

K131244 is an FDA 510(k) clearance for ELECSYS FT4 II ASSAY, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K131244 · Roche Diagnostics · Chemistry device
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Jan 2014
Decision
271d
Days
Class 2
Risk

K131244 is an FDA 510(k) clearance for the ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 27, 2014 after a review of 271 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K131244

510(k) Number K131244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date January 27, 2014
Days to Decision 271 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
183d slower than avg
Panel avg: 88d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K131244.
VIDAS FT4
K132058 · Biomerieux S.A. · Jun 2015
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
K140842 · Siemens Healthcare Diagnostics, Inc. · Nov 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
K140859 · Siemens Healthcare Diagnostics, Inc. · Nov 2014
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · Siemens Healthcare Diagnostics, Inc. · Sep 2013
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