Cleared Traditional

K003174 - ELECSYS DHEA-S

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

K003174 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K003174

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.

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 K003174.
ACCESS DHEA-S REAGENT ASSAY
K040181 · Beckman Coulter, Inc. · Mar 2004
DHEA-S
K973897 · Kmi Diagnostics, Inc. · Nov 1997
DSL DHEA-S-7
K962895 · Diagnostic Systems Laboratories, Inc. · Sep 1996
DSL AACTIVE DHEA EIA KIT
K955114 · Diagnostic Systems Laboratories, Inc. · Feb 1996
SR1 DHEA-S ENZYME IMMUNOASSAY
K942051 · Serono Diagnostics, Inc. · Jul 1994
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014 · Diagnostic Systems Laboratories, Inc. · May 1994