Cleared Traditional

K853867 - PANTEX DIRECT DHEA-S COATED TUBE RADIOI...

K853867 is the FDA 510(k) clearance for PANTEX DIRECT DHEA-S COATED TUBE RADIOI... by Pantex, Div. Bio-Analysis, Inc.. It is a Class 1 Chemistry device (product code JKC) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K853867 · Pantex, Div. Bio-Analysis, Inc. · Chemistry device
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Oct 1985
Decision
17d
Days
Class 1
Risk

K853867 is an FDA 510(k) clearance for the PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 17 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.

View all Pantex, Div. Bio-Analysis, Inc. devices

Submission Details

510(k) Number K853867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1985
Decision Date October 04, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 K853867.
SYNELISA DHEA-SULFATE
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SOPHEIA DHEA-SO4 EIA KIT
K852847 · Diagnostic Products Corp. · Aug 1985
ACTIVE DHEA-SULFATE DSL3500
K851239 · Diagnostic Systems Laboratories, Inc. · Apr 1985
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K842552 · Diagnostic Products Corp. · Aug 1984