Cleared Traditional

K834102 - RA-1000 SYS-T4(THYROXINE)SERUM ANAL

K834102 is an FDA 510(k) clearance for RA-1000 SYS-T4(THYROXINE)SERUM ANAL, manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K834102 · Technicon Instruments Corp. · Chemistry device
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Mar 1984
Decision
107d
Days
Class 2
Risk

K834102 is an FDA 510(k) clearance for the RA-1000 SYS-T4(THYROXINE)SERUM ANAL. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1984 after a review of 107 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K834102

510(k) Number K834102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date March 15, 1984
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
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 K834102.
CEDIA TOTAL T4 ASSAY
K852164 · Microgenics Corp. · Jul 1985
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · Technicon Instruments Corp. · May 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · Terumo Medical Corp. · May 1984
STRATUS TOTAL THYROXINE FLUOROMETRIC
K834210 · American Dade · Mar 1984
TDX THYROXINE
K830683 · Abbott Laboratories · Apr 1983
PARAMOUNT THYROXINE ASSAY
K830136 · Syva Co. · Feb 1983