Cleared Traditional

K791835 - CORALENT COAT 125I CORTISOL RADIOIMM.

K791835 is the FDA 510(k) clearance for CORALENT COAT 125I CORTISOL RADIOIMM. by Radioassay Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K791835 · Radioassay Systems Laboratories, Inc. · Chemistry device
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Sep 1979
Decision
10d
Days
Class 2
Risk

K791835 is an FDA 510(k) clearance for the CORALENT COAT 125I CORTISOL RADIOIMM.. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 10 days - a notably fast clearance cycle.

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: 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 Radioassay Systems Laboratories, Inc. devices

Submission Details

510(k) Number K791835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1979
Decision Date September 27, 1979
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
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 48
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K791835.
QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
K800045 · Bio-Rad · Jan 1980
ANALYTE CORTISOL
K792439 · Technicon Instruments Corp. · Jan 1980
CENTRIA CORTISOL RIA TEST SET
K792243 · Ventrex Laboratories, Inc. · Dec 1979
AUTOPAK CORTISOL TEST DELIVERY SYSTEM
K790906 · Micromedic Systems · Jun 1979
CORTISOL RIA KIT
K790268 · E. R. Squibb & Sons, Inc. · Apr 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · Kallestad Laboratories, Inc. · Jan 1979