Cleared Traditional

K810033 - CORTI-SHURE

K810033 is the FDA 510(k) clearance for CORTI-SHURE by Nuclear Medical Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810033 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Jan 1981
Decision
15d
Days
Class 2
Risk

K810033 is an FDA 510(k) clearance for the CORTI-SHURE. 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 January 21, 1981 after a review of 15 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 Nuclear Medical Laboratories, Inc. devices

Submission Details

510(k) Number K810033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1981
Decision Date January 21, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K810033.
CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
K820341 · E. R. Squibb & Sons, Inc. · Mar 1982
COAT-A-COUNT CORTISOL RIA KIT
K810891 · Diagnostic Products Corp. · Apr 1981
ENDAB CORTISOL KIT
K810192 · Immunotech Corp. · Feb 1981
ARIA II 125 I CORTISOL
K802380 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
CORTISOL125 RADIOIMMUNOASSAY
K802036 · Corning Medical & Scientific · Oct 1980
AMERLEX CORTISOL RIA KIT
K800700 · Amersham Corp. · Apr 1980