Cleared Traditional

TDX THYROXINE (K830683) - FDA 510(k) Clearance

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

K830683 · Abbott Laboratories · Chemistry device
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Apr 1983
Decision
33d
Days
Class 2
Risk

K830683 is an FDA 510(k) clearance for the TDX THYROXINE. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 33 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 Abbott Laboratories devices

Submission Details

510(k) Number K830683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date April 06, 1983
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
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 35
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K830683.
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · Terumo Medical Corp. · May 1984
RA-1000 SYS-T4(THYROXINE)SERUM ANAL
K834102 · Technicon Instruments Corp. · Mar 1984
STRATUS TOTAL THYROXINE FLUOROMETRIC
K834210 · American Dade · Mar 1984
PARAMOUNT THYROXINE ASSAY
K830136 · Syva Co. · Feb 1983
SOPHEIA THYROXINE EIA KIT
K823751 · Diagnostic Products Corp. · Jan 1983
SYVA ADVANCE THYROXINE ASSAY
K823034 · Syva Co. · Nov 1982