Cleared Traditional

SR1 DHEA-S ENZYME IMMUNOASSAY (K942051) - FDA 510(k) Clearance

Class I Toxicology device.

K942051 · Serono Diagnostics, Inc. · Toxicology device
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Jul 1994
Decision
76d
Days
Class 1
Risk

K942051 is an FDA 510(k) clearance for the SR1 DHEA-S ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1245 - 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K942051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date July 13, 1994
Days to Decision 76 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
11d faster than avg
Panel avg: 87d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKC Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1245
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.

Regulatory Peers - JKC Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

All 27
Devices cleared under the same product code (JKC) and FDA review panel - the closest regulatory comparables to K942051.
ACCESS DHEA-S REAGENT ASSAY
K040181 · Beckman Coulter, Inc. · Mar 2004
ELECSYS DHEA-S
K003174 · Roche Diagnostics Corp. · Jan 2001
IMMULITE DHEA-S04
K935806 · Diagnostic Products Corp. · Apr 1994
SOPHEIA DHEA-SO4 EIA KIT
K852847 · Diagnostic Products Corp. · Aug 1985
COAT-A-COUNT DHEA-SO4 RIA KIT
K842552 · Diagnostic Products Corp. · Aug 1984
COAT-A-COUNT DHEA RIA KIT
K842606 · Diagnostic Products Corp. · Aug 1984