Cleared Traditional

K932980 - TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

K932980 is an FDA 510(k) clearance for TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T..., manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K932980 · Sigma Diagnostics, Inc. · Chemistry device
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Oct 1993
Decision
123d
Days
Class 2
Risk

K932980 is an FDA 510(k) clearance for the TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K932980

510(k) Number K932980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1993
Decision Date October 18, 1993
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K932980.
ACTIVE THYROXINE RIA
K954312 · Diagnostic Systems Laboratories, Inc. · Oct 1995
DELFIA NEONATAL THYROXINE KIT
K943416 · Wallac OY · Mar 1995
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · Baxter Diagnostics, Inc. · Aug 1993
ABBOTT IMX T4
K925110 · Abbott Laboratories · Jan 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993