Cleared Traditional

CORTI-COTE CORTISOL SOLID PHASE RADIO (K842365) - FDA 510(k) Clearance

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

K842365 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Aug 1984
Decision
62d
Days
Class 2
Risk

K842365 is an FDA 510(k) clearance for the CORTI-COTE CORTISOL SOLID PHASE RADIO. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 16, 1984 after a review of 62 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K842365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date August 16, 1984
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 19
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K842365.
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · Diagnostic Products Corp. · Oct 1989
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · American Dade · Sep 1984
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · Syva Co. · May 1983
SOPHEIA CORTISOL EIA KIT
K822845 · Diagnostic Products Corp. · Oct 1982
COAT-A-COUNT CORTISOL RIA KIT
K810891 · Diagnostic Products Corp. · Apr 1981