Cleared Traditional

K911093 - CIBA CORNING ACS T UPTAKE IMMUNOASSAY

K911093 is an FDA 510(k) clearance for CIBA CORNING ACS T UPTAKE IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K911093 · Ciba Corning Diagnostics Corp. · Chemistry device
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Apr 1991
Decision
48d
Days
Class 2
Risk

K911093 is an FDA 510(k) clearance for the CIBA CORNING ACS T UPTAKE IMMUNOASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 - K911093

510(k) Number K911093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1991
Decision Date April 29, 1991
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 64
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K911093.
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
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CIBA CORNING ACS T UPTAKE IMMUNOASSAY
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EMIT T-UPTAKE ASSAY
K894145 · Syva Co. · Sep 1989