Cleared Traditional

K841576 - TECHNICON RA-1000 SYS T4-THYROXINE

K841576 is an FDA 510(k) clearance for TECHNICON RA-1000 SYS T4-THYROXINE, 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 35-day FDA review.

K841576 · Technicon Instruments Corp. · Chemistry device
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May 1984
Decision
35d
Days
Class 2
Risk

K841576 is an FDA 510(k) clearance for the TECHNICON RA-1000 SYS T4-THYROXINE. 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 May 22, 1984 after a review of 35 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.

FDA 510(k) Submission Details - K841576

510(k) Number K841576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date May 22, 1984
Days to Decision 35 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
54d faster than avg
Panel avg: 89d · This submission: 35d
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 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K841576.
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · Ciba Corning Diagnostics Corp. · Oct 1986
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
K854971 · V-Tech, Inc. · Feb 1986
CEDIA TOTAL T4 ASSAY
K852164 · Microgenics Corp. · Jul 1985
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · Terumo Medical Corp. · May 1984
VENTREZYME T4 IMMUNOASSAY T4
K840473 · Vxr, Inc. · Apr 1984
THYROXINE EMIA
K840241 · Collaborative Research, Inc. · Mar 1984
K841576 · TECHNICON RA-1000 SYS T4-THYROXINE
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