Cleared Traditional

K851239 - ACTIVE DHEA-SULFATE DSL3500

K851239 is an FDA 510(k) clearance for ACTIVE DHEA-SULFATE DSL3500, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JKC cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K851239 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Apr 1985
Decision
29d
Days
Class 1
Risk

K851239 is an FDA 510(k) clearance for the ACTIVE DHEA-SULFATE DSL3500. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 29 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K851239

510(k) Number K851239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1985
Decision Date April 25, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 89d · This submission: 29d
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 27
Devices cleared under the same product code (JKC) and FDA review panel - the closest regulatory comparables to K851239.
DHEA-S RIA KIT
K872879 · Endocrine Associates, Inc. · Oct 1987
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
K853867 · Pantex, Div. Bio-Analysis, Inc. · Oct 1985
SOPHEIA DHEA-SO4 EIA KIT
K852847 · Diagnostic Products Corp. · Aug 1985
MATCHED COMPONENT SET FOR RADIOIMMUNO-
K843635 · Cambridge Medical Technology · Sep 1984
COAT-A-COUNT DHEA-SO4 RIA KIT
K842552 · Diagnostic Products Corp. · Aug 1984
COAT-A-COUNT DHEA RIA KIT
K842606 · Diagnostic Products Corp. · Aug 1984
K851239 · ACTIVE DHEA-SULFATE DSL3500
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