Cleared Traditional

K810192 - ENDAB CORTISOL KIT

K810192 is the FDA 510(k) clearance for ENDAB CORTISOL KIT by Immunotech Corp.. It is a Class 2 Toxicology device (product code CGR) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810192 · Immunotech Corp. · Toxicology device

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Feb 1981

Decision

14d

Days

Class 2

Risk

K810192 is an FDA 510(k) clearance for the ENDAB CORTISOL KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Immunotech Corp. (Walker, US). The FDA issued a Cleared decision on February 6, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1205 - the FDA toxicology device 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 Immunotech Corp. devices

Submission Details

510(k) Number	K810192 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 23, 1981
Decision Date	February 06, 1981
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

73d faster than avg

Panel avg: 87d · This submission: 14d

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 Toxicology devices follow this clearance model.

Regulatory Peers - CGR Radioimmunoassay, Cortisol

All 45

Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K810192.

SOPHEIA CORTISOL EIA KIT

K822845 · Diagnostic Products Corp. · Oct 1982

DSL 1020

K821068 · Diagnostic Systems Laboratories, Inc. · May 1982

COAT-A-COUNT CORTISOL RIA KIT

K810891 · Diagnostic Products Corp. · Apr 1981

ARIA II 125 I CORTISOL

K802380 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980

CORTISOL125 RADIOIMMUNOASSAY

K802036 · Corning Medical & Scientific · Oct 1980

AMERLEX CORTISOL RIA KIT

K800700 · Amersham Corp. · Apr 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K810192

Immunotech Corp.

Walker, MI · US

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Toxicology

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Sourced from FDA 510(k) public files . Updated monthly.

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