Cleared Traditional

K834210 - STRATUS TOTAL THYROXINE FLUOROMETRIC

K834210 is an FDA 510(k) clearance for STRATUS TOTAL THYROXINE FLUOROMETRIC, manufactured by American Dade. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K834210 · American Dade · Chemistry device
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Mar 1984
Decision
91d
Days
Class 2
Risk

K834210 is an FDA 510(k) clearance for the STRATUS TOTAL THYROXINE FLUOROMETRIC. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 91 days - within the typical 510(k) review window.

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: 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 American Dade devices

FDA 510(k) Submission Details - K834210

510(k) Number K834210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date March 05, 1984
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K834210.
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · Technicon Instruments Corp. · May 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · Terumo Medical Corp. · May 1984
RA-1000 SYS-T4(THYROXINE)SERUM ANAL
K834102 · Technicon Instruments Corp. · Mar 1984
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