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dBest Ovulation Test measures luteinizing hormone (LH), which is always present in women's urine, and increases just before most fertile day of the month. This increase, or "surge" in LH triggers ovulation, which is the release of an egg from ovary. dBest Ovulation Test will help women find the time that when they are most able to become pregnant. Fir accounter USC.

dBest Ovulation luteinizing hormone (LH).

This document is an FDA 510(k) clearance letter for a medical device called the "dBest One-Step Ovulation Test." It indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, or performance data.

The letter is a regulatory approval document and focuses on:

• Confirming substantial equivalence.
• Indicating the regulatory class (Class I) and product code (CEP).
• Stating that the device can be marketed.
• Outlining general controls and other FDA regulations applicable to the device.
• Referencing the "Indications For Use" statement (which is included in a subsequent part of the document) but not the actual study data.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, ground truth details, or information about MRMC studies based solely on the provided text.

The "Indications for Use" section (part 2 of the input) describes what the device does (measures luteinizing hormone to help women find their most fertile time) but does not provide performance metrics or study details.

Ask a specific question about this device