Cleared Traditional

K834219 - PHASE II CORTISOL KIT

K834219 is the FDA 510(k) clearance for PHASE II CORTISOL KIT by Medical & Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K834219 · Medical & Scientific Designs, Inc. · Chemistry device
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Feb 1984
Decision
61d
Days
Class 2
Risk

K834219 is an FDA 510(k) clearance for the PHASE II CORTISOL KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 61 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 Medical & Scientific Designs, Inc. devices

Submission Details

510(k) Number K834219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date February 04, 1984
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
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 K834219.
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · American Dade · Sep 1984
CORNING MAGIC CORTISOL RADIOIMMUNO
K841641 · Corning Medical & Scientific · Sep 1984
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
SOPHEIA CORTISOL EIA KIT
K822845 · Diagnostic Products Corp. · Oct 1982
DSL 1020
K821068 · Diagnostic Systems Laboratories, Inc. · May 1982