Cleared Abbreviated

K040181 - ACCESS DHEA-S REAGENT ASSAY

K040181 is an FDA 510(k) clearance for ACCESS DHEA-S REAGENT ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 1 Chemistry device with product code JKC cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K040181 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
57d
Days
Class 1
Risk

K040181 is an FDA 510(k) clearance for the ACCESS DHEA-S REAGENT ASSAY. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 24, 2004 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1245 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K040181

510(k) Number K040181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2004
Decision Date March 24, 2004
Days to Decision 57 days
Submission Type Abbreviated
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
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 K040181.
ELECSYS DHEA-S
K003174 · Roche Diagnostics Corp. · Jan 2001
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