Predict & Confirm™ Successful Ovulation

Description

Proov: Predict & Confirm™ Successful Ovulation

Compliance Review & Modifications (21 CFR § 101.93):

• High-Risk Medical Claims: Removed the claim "Tests to Increase Your Pregnancy Chances." Under 21 CFR § 101.93, implying that a product directly increases the likelihood of pregnancy or treats infertility is considered an unauthorized drug/medical device claim.

• Outcome-Based Statistics: Removed the specific statistic that a high score can "increase pregnancy rates by up to 75%." Marketing a specific percentage increase in clinical outcomes for a wellness monitoring tool is high-risk and likely to be flagged as a therapeutic claim.

• Structure/Function Pivot: Shifted the focus from "reaching pregnancy goals faster" to "monitoring hormone patterns" and "identifying the fertile window." This frames the product as a tool for tracking normal physiological markers.

• Formatting Update: The mandatory FDA disclaimer is placed at the bottom, italicized, and not indented.

Revised Description Text:

The Proov Predict & Confirm™ System offers a comprehensive approach to cycle monitoring by tracking two key fertility hormone markers. This kit allows you to map your full ovulation picture from home, providing data to help you understand your unique hormone patterns.

• Predict Your Window: Includes 15 LH (Luteinizing Hormone) tests to identify your most fertile days by detecting the hormonal surge that precedes ovulation.*

• Confirm Your Pattern: Features 5 FDA-cleared PdG (Progesterone metabolite) tests to monitor hormone levels during the critical post-ovulation window.*

• Data-Driven Insights: Get a Proov-exclusive ovulation score to help you track and visualize your cycle's hormonal health.

• App Integrated: Pairs with the free Proov Insight companion app for testing reminders, digital result interpretation, and personalized wellness tracking.

Kit Includes: 15 LH test strips and 5 PdG test strips (1-cycle supply).

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.