Cleared Traditional

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (K932980) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 120
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K932980.
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ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
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THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991