Cleared Traditional

COAT-A-COUNT(R) ESTRADIOL-6 (K943193) - FDA 510(k) Clearance

Class I Chemistry device.

K943193 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
233d
Days
Class 1
Risk

K943193 is an FDA 510(k) clearance for the COAT-A-COUNT(R) ESTRADIOL-6. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 23, 1995 after a review of 233 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 K943193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date February 23, 1995
Days to Decision 233 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 88d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 49
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K943193.
ELECSYS ESTRADIOL ASSAY
K965109 · Boehringer Mannheim Corp. · Feb 1997
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992
ENZYMUN-TEST ESTRADIOL
K913162 · Boehringer Mannheim Corp. · Sep 1991
MILENIA ESTRADIOL
K912917 · Diagnostic Products Corp. · Jul 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · Baxter Healthcare Corp · Feb 1991