Cleared Traditional

SYNELISA DHEA-SULFATE (K935469) - FDA 510(k) Clearance

Class I Chemistry device.

K935469 · Elias U.S.A., Inc. · Chemistry device
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Mar 1994
Decision
139d
Days
Class 1
Risk

K935469 is an FDA 510(k) clearance for the SYNELISA DHEA-SULFATE. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1245 - 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 Elias U.S.A., Inc. devices

Submission Details

510(k) Number K935469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1993
Decision Date March 22, 1994
Days to Decision 139 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 88d · This submission: 139d
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 K935469.
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