Cleared Traditional

K935469 - SYNELISA DHEA-SULFATE

K935469 is an FDA 510(k) clearance for SYNELISA DHEA-SULFATE, manufactured by Elias U.S.A., Inc.. The device is a Class 1 Chemistry device with product code JKC cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K935469 · Elias U.S.A., Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K935469

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 88d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

JKC Device Classification - Class 1, General Controls

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 17
Devices cleared under the same product code (JKC) and FDA review panel - the closest regulatory comparables to K935469.
SR1 DHEA-S ENZYME IMMUNOASSAY
K942051 · Serono Diagnostics, Inc. · Jul 1994
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014 · Diagnostic Systems Laboratories, Inc. · May 1994
IMMULITE DHEA-S04
K935806 · Diagnostic Products Corp. · Apr 1994
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
K903616 · Diagnostic Systems Laboratories, Inc. · Sep 1990
DSL 7900 ACTIVE DHEA-S (DSL #7900)
K891478 · Diagnostic Systems Laboratories, Inc. · Apr 1989
SOPHEIA DHEA-SO4 EIA KIT
K852847 · Diagnostic Products Corp. · Aug 1985