Cleared Traditional

K821861 - COAT-A-COUNT INSULIN KIT

K821861 is the FDA 510(k) clearance for COAT-A-COUNT INSULIN KIT by Diagnostic Products Corp.. It is a Class 1 Chemistry device (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

Submission Details

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.

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 14
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K821861.
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · Helena Laboratories · Jan 1990
PHARMACIA INSULIN RIA
K851071 · Pharmacia, Inc. · Apr 1985
WAKO INSULIN TEST
K823939 · Wako Chemicals USA, Inc. · Jan 1983
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