Cleared Traditional

K003174 - ELECSYS DHEA-S

K003174 is the FDA 510(k) clearance for ELECSYS DHEA-S by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code JKC) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K003174 · Roche Diagnostics Corp. · Chemistry device
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Jan 2001
Decision
99d
Days
Class 1
Risk

K003174 is an FDA 510(k) clearance for the ELECSYS DHEA-S. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 17, 2001 after a review of 99 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K003174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date January 17, 2001
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 12
Devices cleared under the same product code (JKC) and FDA review panel - the closest regulatory comparables to K003174.
ACCESS DHEA-S REAGENT ASSAY
K040181 · Beckman Coulter, Inc. · Mar 2004
DSL DHEA-S-7
K962895 · Diagnostic Systems Laboratories, Inc. · Sep 1996
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