Cleared Traditional

K952557 - TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS

K952557 is an FDA 510(k) clearance for TOTAL T-3 FPIA REAGENT SET, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K952557 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
236d
Days
Class 2
Risk

K952557 is an FDA 510(k) clearance for the TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 236 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 - K952557

510(k) Number K952557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date January 24, 1996
Days to Decision 236 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
148d slower than avg
Panel avg: 88d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K952557.
ACCESS FREE T3 ASSAY
K960913 · Bio-Rad Laboratories, Inc. · Mar 1996
T-3 MICROWELL EIA MODEL 7013
K960412 · Biomerica, Inc. · Mar 1996
ACTIVE T3 RIA
K960550 · Diagnostic Systems Laboratories, Inc. · Mar 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · Bio-Rad Laboratories, Inc. · Jan 1996
OPUS T3
K953160 · Behring Diagnostics, Inc. · Aug 1995
IMX T3 ASSAY
K944808 · Organon Teknika Corp. · Dec 1994