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The QuantRx Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women who are attempting to conceive.

The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurement of follicle-stimulating hormone (FSH) in human urine. The test is performed on day 3 of the menstrual cycle by urinating directly on the absorbent tip or by dipping it in a cup of urine, and observing for the formation of colored lines after 10 minutes. A test line of color intensity greater than or equal to the reference line indicates an FSH level of at least 10 mIU/mL is indicative of diminished ovarian reserve, which corresponds to reduced fertility. A test line intensity of less than the reference line is indicative of normal ovarian reserve.

Here's a breakdown of the acceptance criteria and study details for the QuantRx Female Fertility Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

• Concordance (trained user) between proposed device vs. laboratory method | 89% |
  | - Concordance (layperson) between proposed device vs. laboratory method | 88% |
  | - Concordance trained user vs. layperson for primary study | 98% |
  | Supplemental Study:
• Concordance (trained user) between proposed device vs. predicate | 94% |
  | - Concordance (layperson) between proposed device vs. predicate | 92% |
  | - Concordance trained user vs. layperson for supplemental study | 98% |
  | The device is intended to measure FSH in urine, with a test line intensity equal to or darker than the reference line (calibrated at 10 mIU/mL) indicating FSH ≥ 10 mIU/mL, and a lighter intensity indicating FSH

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