Cleared Special

MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223) - FDA 510(k) Clearance

Class I Chemistry device.

K990223 · Unipath , Ltd. · Chemistry device
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Feb 1999
Decision
30d
Days
Class 1
Risk

K990223 is an FDA 510(k) clearance for the MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR. Classified as Test, Luteinizing Hormone (lh), Over The Counter (product code NGE), Class I - General Controls.

Submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on February 24, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Unipath , Ltd. devices

Submission Details

510(k) Number K990223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date February 24, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NGE Test, Luteinizing Hormone (lh), Over The Counter
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.