Cleared Traditional

SOPHEIA THYROXINE EIA KIT (K823751) - FDA 510(k) Clearance

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

K823751 · Diagnostic Products Corp. · Chemistry device
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Jan 1983
Decision
29d
Days
Class 2
Risk

K823751 is an FDA 510(k) clearance for the SOPHEIA THYROXINE EIA KIT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1983 after a review of 29 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 Products Corp. devices

Submission Details

510(k) Number K823751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date January 12, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 Chemistry devices follow this clearance model.

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

All 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K823751.
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · Instrumentation Laboratory CO · Aug 1990
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · Syva Co. · Apr 1989
EMIT THYROXINE ASSAY
K885141 · Syva Co. · Feb 1989