Cleared Traditional

K862336 - PANCOAT CORTISOL COATED TUBE RADIOIMMUN...

K862336 is the FDA 510(k) clearance for PANCOAT CORTISOL COATED TUBE RADIOIMMUN... by Pantex, Div. Bio-Analysis, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K862336 · Pantex, Div. Bio-Analysis, Inc. · Chemistry device
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Sep 1986
Decision
97d
Days
Class 2
Risk

K862336 is an FDA 510(k) clearance for the PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - 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 Pantex, Div. Bio-Analysis, Inc. devices

Submission Details

510(k) Number K862336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1986
Decision Date September 25, 1986
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGR Radioimmunoassay, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGR Radioimmunoassay, Cortisol

All 42
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K862336.
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · Diagnostic Products Corp. · Oct 1989
DSL 7800 ACTIVE CORTISOL
K884689 · Diagnostic Systems Laboratories, Inc. · Feb 1989
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · Amersham Corp. · Mar 1988
ACTIVE CORTISOL DSL 2000-SP
K850141 · Diagnostic Systems Laboratories, Inc. · Feb 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · American Dade · Sep 1984