Cleared Traditional

DPC COAT-A-COUNT IRMA LH KIT (K863934) - FDA 510(k) Clearance

Class I Chemistry device.

K863934 · Diagnostic Products Corp. · Chemistry device
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Feb 1987
Decision
120d
Days
Class 1
Risk

K863934 is an FDA 510(k) clearance for the DPC COAT-A-COUNT IRMA LH KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 K863934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1986
Decision Date February 06, 1987
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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 - CEP Radioimmunoassay, Luteinizing Hormone

All 142
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K863934.
ELECSYS LH ASSAY
K964694 · Boehringer Mannheim Corp. · Jan 1997
COAT-A-COUNT LH IRMA
K951748 · Diagnostic Products Corp. · May 1995
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990
ENZYMUN TEST(R) LH
K900779 · Boehringer Mannheim Corp. · Apr 1990