Cleared Special

K990223 - MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR

K990223 is an FDA 510(k) clearance for MODIFICATION OF CLEARPLAN EASY FERTILIT..., manufactured by Unipath , Ltd.. The device is a Class 1 Chemistry device with product code NGE cleared through the Special 510(k) pathway after a 30-day FDA review.

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.

FDA 510(k) Submission Details - K990223

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NGE Device Classification - Class 1, General Controls

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.

Regulatory Peers - NGE Test, Luteinizing Hormone (lh), Over The Counter

Devices cleared under the same product code (NGE) and FDA review panel - the closest regulatory comparables to K990223.
FERTILITE OV
K020808 · Pheromone Sciences Corp. · Sep 2002
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K863121 · Micron Technology, Inc. · Oct 1986
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K850579 · Zetek, Inc. · Mar 1985
K990223 · MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
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