Cleared Traditional

K944490 - AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (FDA 510(k) Clearance)

Class I Toxicology device.

K944490 · Wallac OY · Toxicology device
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Dec 1994
Decision
87d
Days
Class 1
Risk

K944490 is an FDA 510(k) clearance for the AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on December 9, 1994 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1265 - the FDA toxicology device 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 Wallac OY devices

Submission Details

510(k) Number K944490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date December 09, 1994
Days to Decision 87 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 87d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGI Radioimmunoassay, Estriol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1265
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.