Cleared Traditional

DHEA TEST SET (K771793) - FDA 510(k) Clearance

Class I Immunology device.

K771793 · Wien Laboratories, Inc. · Immunology device
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Nov 1977
Decision
41d
Days
Class 1
Risk

K771793 is an FDA 510(k) clearance for the DHEA TEST SET. Classified as Radioimmunoassay, Androsterone (product code CIY), Class I - General Controls.

Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1080 - the FDA immunology 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 Wien Laboratories, Inc. devices

Submission Details

510(k) Number K771793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1977
Decision Date November 02, 1977
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CIY Radioimmunoassay, Androsterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1080
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.