Cleared Traditional

K810192 - ENDAB CORTISOL KIT

K810192 is an FDA 510(k) clearance for ENDAB CORTISOL KIT, manufactured by Immunotech Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K810192

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.

CGR Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K810192.
DSL 1020
K821068 · Diagnostic Systems Laboratories, Inc. · May 1982
CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
K820341 · E. R. Squibb & Sons, Inc. · Mar 1982
COAT-A-COUNT CORTISOL RIA KIT
K810891 · Diagnostic Products Corp. · Apr 1981
CORTI-SHURE
K810033 · Nuclear Medical Laboratories, Inc. · Jan 1981
ARIA II 125 I CORTISOL
K802380 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
CORTISOL125 RADIOIMMUNOASSAY
K802036 · Corning Medical & Scientific · Oct 1980