Cleared Traditional

K935469 - SYNELISA DHEA-SULFATE

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

K935469 · Elias U.S.A., Inc. · Chemistry device
Download Printable Device Report (PDF)
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

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
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.

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 14
Devices cleared under the same product code (JKC) and FDA review panel - the closest regulatory comparables to K935469.
DSL AACTIVE DHEA EIA KIT
K955114 · Diagnostic Systems Laboratories, Inc. · Feb 1996
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