Cleared Traditional

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K870969) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 18
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K870969.
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993
ENZYMUN TEST(R) CORTISOL
K900485 · Boehringer Mannheim Corp. · May 1990
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · Diagnostic Products Corp. · Oct 1989
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985
CORTI-COTE CORTISOL SOLID PHASE RADIO
K842365 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1984
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · Syva Co. · May 1983