Cleared Traditional

K870969 - CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

K870969 is an FDA 510(k) clearance for CORTISOL-RIA KIT COATED TUBE RADIOIMMUN..., manufactured by Canadian Bioclinical, Ltd.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K870969 · Canadian Bioclinical, Ltd. · Chemistry device
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Jun 1987
Decision
104d
Days
Class 2
Risk

K870969 is an FDA 510(k) clearance for the CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Canadian Bioclinical, Ltd. (Ontario Mix 1b4, CA). The FDA issued a Cleared decision on June 22, 1987 after a review of 104 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 Canadian Bioclinical, Ltd. devices

FDA 510(k) Submission Details - K870969

510(k) Number K870969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1987
Decision Date June 22, 1987
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGR Radioimmunoassay, Cortisol

All 61
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K870969.
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
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
K872177 · Nuclear Diagnostics, Inc. · Jun 1987
ACTIVE CORTISOL DSL 2000-SP
K850141 · Diagnostic Systems Laboratories, Inc. · Feb 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985