Cleared Traditional

K812227 - GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY

K812227 is the FDA 510(k) clearance for GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY by Clinical Assays, Inc.. It is a Class 1 Chemistry device (product code CFP) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K812227 · Clinical Assays, Inc. · Chemistry device
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Sep 1981
Decision
45d
Days
Class 1
Risk

K812227 is an FDA 510(k) clearance for the GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1405 - 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 Clinical Assays, Inc. devices

Submission Details

510(k) Number K812227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1981
Decision Date September 24, 1981
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFP Radioimmunoassay, Immunoreactive Insulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1405
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CFP Radioimmunoassay, Immunoreactive Insulin

All 17
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K812227.
WAKO INSULIN TEST
K823939 · Wako Chemicals USA, Inc. · Jan 1983
COAT-A-COUNT INSULIN KIT
K821861 · Diagnostic Products Corp. · Jul 1982
ENZYMUNE-TEST INSULIN
K821374 · Icl Scientific · May 1982
IMMOPHASE INSULIN (125I) RADIOASSAY
K811953 · Corning Medical & Scientific · Jul 1981
VENTRE/SEP
K811423 · Ventrex Laboratories, Inc. · Jun 1981
ARIA II INSULIN RIA
K811144 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981