Cleared Traditional

K872447 - CEDIA(TM) T UPTAKE

K872447 is the FDA 510(k) clearance for CEDIA(TM) T UPTAKE by Microgenics Corp.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K872447 · Microgenics Corp. · Chemistry device
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Aug 1987
Decision
59d
Days
Class 2
Risk

K872447 is an FDA 510(k) clearance for the CEDIA(TM) T UPTAKE. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on August 21, 1987 after a review of 59 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 Microgenics Corp. devices

Submission Details

510(k) Number K872447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date August 21, 1987
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 53
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K872447.
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AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
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IMMUBEAD THYROID UPTAKE
K872172 · Immunotech Corp. · Aug 1987
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K864132 · Ciba Corning Diagnostics Corp. · Dec 1986