Cleared Traditional

K823034 - SYVA ADVANCE THYROXINE ASSAY

K823034 is the FDA 510(k) clearance for SYVA ADVANCE THYROXINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code KLI) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K823034 · Syva Co. · Toxicology device
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Nov 1982
Decision
18d
Days
Class 2
Risk

K823034 is an FDA 510(k) clearance for the SYVA ADVANCE THYROXINE ASSAY. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1700 - the FDA toxicology device 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 Syva Co. devices

Submission Details

510(k) Number K823034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1982
Decision Date November 08, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 Toxicology devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 56
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K823034.
TDX THYROXINE
K830683 · Abbott Laboratories · Apr 1983
PARAMOUNT THYROXINE ASSAY
K830136 · Syva Co. · Feb 1983
SOPHEIA THYROXINE EIA KIT
K823751 · Diagnostic Products Corp. · Jan 1983
ENZYMUNE-TEST T4
K820750 · Icl Scientific · Apr 1982
EMIT-TFG PRISMA THYROXINE ASSAY
K810586 · Syva Co. · Mar 1981
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · Organon, Inc. · Dec 1980