Cleared Traditional

CUE FERTILITY MONITOR (K850579) - FDA 510(k) Clearance

Class I Toxicology device.

K850579 · Zetek, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
37d
Days
Class 1
Risk

K850579 is an FDA 510(k) clearance for the CUE FERTILITY MONITOR. Classified as Test, Luteinizing Hormone (lh), Over The Counter (product code NGE), Class I - General Controls.

Submitted by Zetek, Inc. (Chicago, US). The FDA issued a Cleared decision on March 22, 1985 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zetek, Inc. devices

Submission Details

510(k) Number K850579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1985
Decision Date March 22, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

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.