Cleared Traditional

COAT-A-COUNT FREE & TOTAL ESTRIOL KIT (K812768) - FDA 510(k) Clearance

Class I Chemistry device.

K812768 · Diagnostic Products Corp. · Chemistry device
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Jan 1982
Decision
105d
Days
Class 1
Risk

K812768 is an FDA 510(k) clearance for the COAT-A-COUNT FREE & TOTAL ESTRIOL KIT. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1265 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K812768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1981
Decision Date January 18, 1982
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGI Radioimmunoassay, Estriol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1265
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 - CGI Radioimmunoassay, Estriol

All 41
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K812768.
COAT-A-COUNT FREE ESTRIOL
K932989 · Diagnostic Products Corp. · Dec 1994
TDX TOTAL ESTRIOL
K844511 · Abbott Laboratories · Jan 1985
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1980
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977