Cleared Traditional

K840050 - SOPHEIA T3 EIA KIT

K840050 is the FDA 510(k) clearance for SOPHEIA T3 EIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K840050 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
73d
Days
Class 2
Risk

K840050 is an FDA 510(k) clearance for the SOPHEIA T3 EIA KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 73 days - a notably fast clearance 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: 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 K840050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date March 19, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K840050.
AMERLEX-M FREE T-3 RIA
K842949 · Amersham Corp. · Sep 1984
CORNING IMMO PHASE FREE T3
K840222 · Corning Medical & Scientific · May 1984
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
K840959 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
LEECO T3-QUANT DIAG. KIT
K834348 · Leeco Diagnostics, Inc. · Feb 1984
COAT-A-COUNT FREE T3 RIA KIT
K832164 · Diagnostic Products Corp. · Oct 1983
CORNING'S MAGIC T3(125I) RADIOIMMUNO-
K832353 · Corning Medical & Scientific · Aug 1983