Cleared Traditional

K855169 - T3 UPTAKE RADIOIMMUNOASSAY KIT

K855169 is the FDA 510(k) clearance for T3 UPTAKE RADIOIMMUNOASSAY KIT by Cambridge Medical Technology. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K855169 · Cambridge Medical Technology · Chemistry device
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Feb 1986
Decision
42d
Days
Class 2
Risk

K855169 is an FDA 510(k) clearance for the T3 UPTAKE RADIOIMMUNOASSAY KIT. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Cambridge Medical Technology (Billerica, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 42 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 Cambridge Medical Technology devices

Submission Details

510(k) Number K855169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 06, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K855169.
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY
K864132 · Ciba Corning Diagnostics Corp. · Dec 1986
MMS T3 UPTAKE
K861262 · Micromedic Systems · May 1986
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · American Dade · Apr 1986
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · Terumo Medical Corp. · Sep 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
K834209 · American Dade · Mar 1984
ACA THYROXINE UPTAKE ANALYTICAL TEST
K833703 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984