Cleared Traditional

K840466 - NML CORTISOL RIA

K840466 is an FDA 510(k) clearance for NML CORTISOL RIA, manufactured by Nuclear Medical Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K840466 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Mar 1984
Decision
56d
Days
Class 2
Risk

K840466 is an FDA 510(k) clearance for the NML CORTISOL RIA. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Nuclear Medical Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 56 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.

FDA 510(k) Submission Details - K840466

510(k) Number K840466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1984
Decision Date March 30, 1984
Days to Decision 56 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
33d faster than avg
Panel avg: 89d · This submission: 56d
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 83
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K840466.
CORTI-COTE CORTISOL SOLID PHASE RADIO
K842365 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1984
AMER. BIO-SCIENCE LAB CORTISOL REAGENT
K842455 · American Bio-Science Laboratories · Aug 1984
IMMPULSE CORTISOL ASSAY REAGENTS
K842554 · Aktis Corp. · Aug 1984
PHASE II CORTISOL KIT
K834219 · Medical & Scientific Designs, Inc. · Feb 1984
CORTISOL RADIOIMMUNOASSAY KIT
K832638 · Bioclinical Group · Sep 1983
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · Syva Co. · May 1983
K840466 · NML CORTISOL RIA
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