Cleared Traditional

K821861 - COAT-A-COUNT INSULIN KIT

K821861 is an FDA 510(k) clearance for COAT-A-COUNT INSULIN KIT, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code CFP cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821861 · Diagnostic Products Corp. · Chemistry device
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Jul 1982
Decision
14d
Days
Class 1
Risk

K821861 is an FDA 510(k) clearance for the COAT-A-COUNT INSULIN KIT. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1982 after a review of 14 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K821861

510(k) Number K821861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1982
Decision Date July 08, 1982
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

CFP Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K821861.
INSULIN RADIOIMMUNOASSAY KIT
K841573 · Sorin Biomedica, Fiat, USA, Inc. · May 1984
WAKO INSULIN TEST
K823939 · Wako Chemicals USA, Inc. · Jan 1983
COVALENT COAT RIA KIT
K822509 · Immuchem Corp. · Sep 1982
ENZYMUNE-TEST INSULIN
K821374 · Icl Scientific · May 1982
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
K812227 · Clinical Assays, Inc. · Sep 1981
IMMOPHASE INSULIN (125I) RADIOASSAY
K811953 · Corning Medical & Scientific · Jul 1981