Cleared Traditional

K874603 - CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOA...

K874603 is an FDA 510(k) clearance for CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOA..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K874603 · Ciba Corning Diagnostics Corp. · Chemistry device
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Dec 1987
Decision
39d
Days
Class 2
Risk

K874603 is an FDA 510(k) clearance for the CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY). Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on December 18, 1987 after a review of 39 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K874603

510(k) Number K874603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date December 18, 1987
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 59
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K874603.
EMIT THYROXINE ASSAY
K880620 · Syva Co. · Mar 1988
VISION(R) THYROXINE (T4)
K880662 · Abbott Laboratories · Mar 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866 · Serono Diagnostics, Inc. · Feb 1988
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976 · Amersham Corp. · Nov 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192 · Immunotech Corp. · Aug 1987