Cleared Traditional

K874875 - CHEMELIA FREE THYROXINE(FT4)/ENZYME IMM...

K874875 is the FDA 510(k) clearance for CHEMELIA FREE THYROXINE(FT4)/ENZYME IMM... by Boots-Celltech Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K874875 · Boots-Celltech Diagnostics, Inc. · Chemistry device
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Mar 1988
Decision
118d
Days
Class 2
Risk

K874875 is an FDA 510(k) clearance for the CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA). Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (East Hanover, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Boots-Celltech Diagnostics, Inc. devices

Submission Details

510(k) Number K874875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1987
Decision Date March 24, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 65
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