Cleared Traditional

K862233 - CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)

K862233 is an FDA 510(k) clearance for CIBA CORNING PRISMA T4 LIPIA (LIPOSOME), 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 125-day FDA review.

K862233 · Ciba Corning Diagnostics Corp. · Chemistry device
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Oct 1986
Decision
125d
Days
Class 2
Risk

K862233 is an FDA 510(k) clearance for the CIBA CORNING PRISMA T4 LIPIA (LIPOSOME). 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 October 14, 1986 after a review of 125 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K862233

510(k) Number K862233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1986
Decision Date October 14, 1986
Days to Decision 125 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
37d slower than avg
Panel avg: 88d · This submission: 125d
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 K862233.
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
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