Cleared Traditional

K973860 - OVULON MONITOR

K973860 is an FDA 510(k) clearance for OVULON MONITOR, manufactured by Conception Technology, Inc.. The device is a Class 1 Toxicology device with product code NGE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973860 · Conception Technology, Inc. · Toxicology device
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Jan 1998
Decision
90d
Days
Class 1
Risk

K973860 is an FDA 510(k) clearance for the OVULON MONITOR. Classified as Test, Luteinizing Hormone (lh), Over The Counter (product code NGE), Class I - General Controls.

Submitted by Conception Technology, Inc. (Ft. Collins, US). The FDA issued a Cleared decision on January 7, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1485 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Conception Technology, Inc. devices

FDA 510(k) Submission Details - K973860

510(k) Number K973860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1997
Decision Date January 07, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

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.