Cleared Traditional

CLEARPLANE EASY OVULATION TEST (K013874) - FDA 510(k) Clearance

Class I Chemistry device.

K013874 · Unipath , Ltd. · Chemistry device
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Feb 2002
Decision
90d
Days
Class 1
Risk

K013874 is an FDA 510(k) clearance for the CLEARPLANE EASY OVULATION TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Unipath , Ltd. (New York, US). The FDA issued a Cleared decision on February 19, 2002 after a review of 90 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 Unipath , Ltd. devices

Submission Details

510(k) Number K013874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date February 19, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K013874.
ELECSYS LH ASSAY
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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
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990