Cleared Traditional

CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) (K862233) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 35
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K862233.
VISION(R) THYROXINE (T4)
K880662 · Abbott Laboratories · Mar 1988
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603 · Ciba Corning Diagnostics Corp. · Dec 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · Technicon Instruments Corp. · May 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · Terumo Medical Corp. · May 1984
RA-1000 SYS-T4(THYROXINE)SERUM ANAL
K834102 · Technicon Instruments Corp. · Mar 1984