Cleared Traditional

K853208 - 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY (FDA 510(k) Clearance)

Class I Chemistry device.

K853208 · Travenol Laboratories, S.A. · Chemistry device
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Aug 1985
Decision
19d
Days
Class 1
Risk

K853208 is an FDA 510(k) clearance for the 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Cambridge, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K853208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1985
Decision Date August 19, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.