Cleared Traditional

K935806 - IMMULITE DHEA-S04

K935806 is the FDA 510(k) clearance for IMMULITE DHEA-S04 by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code JKC) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K935806 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
145d
Days
Class 1
Risk

K935806 is an FDA 510(k) clearance for the IMMULITE DHEA-S04. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 145 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K935806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date April 26, 1994
Days to Decision 145 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
57d slower than avg
Panel avg: 88d · This submission: 145d
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 K935806.
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
SYNELISA DHEA-SULFATE
K935469 · Elias U.S.A., Inc. · Mar 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