Cleared Traditional

K870268 - DIAGNOSTIC KIT FREE T3 AND FREE T4

K870268 is an FDA 510(k) clearance for DIAGNOSTIC KIT FREE T3 AND FREE T4, manufactured by Sclavo, Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K870268 · Sclavo, Inc. · Chemistry device
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Sep 1987
Decision
234d
Days
Class 2
Risk

K870268 is an FDA 510(k) clearance for the DIAGNOSTIC KIT FREE T3 AND FREE T4. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on September 14, 1987 after a review of 234 days - an extended review cycle.

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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K870268

510(k) Number K870268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1987
Decision Date September 14, 1987
Days to Decision 234 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
146d slower than avg
Panel avg: 88d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

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 78
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