Cleared Traditional

TERUMO SENSIBEAD THYROXINE EIA KIT (K841601) - FDA 510(k) Clearance

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

K841601 · Terumo Medical Corp. · Chemistry device
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May 1984
Decision
34d
Days
Class 2
Risk

K841601 is an FDA 510(k) clearance for the TERUMO SENSIBEAD THYROXINE EIA KIT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 34 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 Terumo Medical Corp. devices

Submission Details

510(k) Number K841601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1984
Decision Date May 22, 1984
Days to Decision 34 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: 88d · This submission: 34d
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 41
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K841601.
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · Ciba Corning Diagnostics Corp. · Oct 1986
CEDIA TOTAL T4 ASSAY
K852164 · Microgenics Corp. · Jul 1985
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · Technicon Instruments 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
TDX THYROXINE
K830683 · Abbott Laboratories · Apr 1983