Cleared Traditional

K954312 - ACTIVE THYROXINE RIA

K954312 is the FDA 510(k) clearance for ACTIVE THYROXINE RIA by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K954312 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Oct 1995
Decision
22d
Days
Class 2
Risk

K954312 is an FDA 510(k) clearance for the ACTIVE THYROXINE RIA. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on October 7, 1995 after a review of 22 days - a notably fast clearance cycle.

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: 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K954312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date October 07, 1995
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K954312.
ELECSYS T4 ASSAY
K961490 · Boehringer Mannheim Corp. · Jun 1996
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · Sigma Diagnostics, Inc. · Oct 1993
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