Cleared Traditional

K800045 - QUANTIMUNE CORTISOL RIA CORTISOL RADIO-

K800045 is the FDA 510(k) clearance for QUANTIMUNE CORTISOL RIA CORTISOL RADIO- by Bio-Rad. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800045 · Bio-Rad · Chemistry device
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Jan 1980
Decision
15d
Days
Class 2
Risk

K800045 is an FDA 510(k) clearance for the QUANTIMUNE CORTISOL RIA CORTISOL RADIO-. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 15 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 Bio-Rad devices

Submission Details

510(k) Number K800045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1980
Decision Date January 23, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
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: 88d · This submission: 15d
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 45
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K800045.
AMERLEX CORTISOL RIA KIT
K800700 · Amersham Corp. · Apr 1980
VENTRE/SEP CORTISOL RIA
K800594 · Ventrex Laboratories, Inc. · Apr 1980
EMIT AUTO CORTISOL ASSAY
K800245 · Syva Co. · Mar 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