Cleared Traditional

K812768 - COAT-A-COUNT FREE & TOTAL ESTRIOL KIT

K812768 is an FDA 510(k) clearance for COAT-A-COUNT FREE & TOTAL ESTRIOL KIT, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code CGI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K812768

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

CGI Device Classification - Class 1, General Controls

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 31
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K812768.
DSL 1400
K822314 · Diagnostic Systems Laboratories, Inc. · Sep 1982
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
K821678 · Micromedic Systems · Jun 1982
QUANTIMUNE ESTRIOL RIA
K820728 · Bio-Rad · Apr 1982
QUANTIMUNE ESTRIOL RIA
K811709 · Bio-Rad · Jul 1981
NATAL-TEC ESTRIOL
K811371 · Armkel, LLC · May 1981
AMERLEX ESTRIOL RIA KIT
K810667 · Amersham Corp. · Mar 1981