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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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The Fertell Female Fertility Test is intended to measure Follicle Stimulating Hormone ("FSH") in urine as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.

The Fertell Female Fertility Test is a dipstick, lateral flow rapid test that measures FSH in an instream urine sample. The test is performed two days after the onset of menses (day 3 of the menstrual cycle) and is similar in design and use to a pregnancy test or an ovulation prediction test. It uses a monoclonal antibody to one antigenic determinant that is conjugated with colloidal gold and a second monoclonal antibody to a different antigenic determinant, the latter antibody being immobilized as a line on a nitrocellulose strip. FSH present in the urine reacts with the conjugated antibody and immobilized antibody, forming a "sandwich" immunocomplex at the site of the immobilized antibody. Unreacted conjugate is washed from the strip by the flow of excess sample. The appearance of a clear red line (test result) indicates FSH in the urine sample, with the intensity of the line proportional to the FSH concentration.

The nitrocellulose strip also has a comparator line of fixed intensity that corresponds to an FSH concentration of 10 IU/L. A test line of color intensity greater than or equal to the comparator line indicates a concentration of FSH of 10 IU/L or greater. This level is indicative of diminished ovarian reserve.

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

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size used for the test set in the consumer study. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. The professional comparisons are mentioned, but no details on their role in defining ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided text. The study focuses on lay user performance and comparison to professional or quantitative methods rather than evaluating human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was conducted for the device. The "lay user also demonstrated >90% accuracy when compared to a professional. and when compared to a quantitative serum FSH tests, the Fertell Female Fertility test demonstrated >95% accuracy." This indicates the device's performance independent of real-time human interpretation, comparing its output directly to reference standards.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation includes:

• Professional observation/interpretation: For assessing lay user accuracy.
• Quantitative serum FSH tests: For assessing the accuracy of the device's FSH measurement.

8. Sample Size for the Training Set

The document does not provide information about a specific training set or its sample size. This is a rapid diagnostic test, and typically, such devices are developed and validated rather than "trained" in the machine learning sense. The testing described likely covers validation rather than a separate training phase.

9. How the Ground Truth for the Training Set Was Established

As no specific training set is mentioned in the provided text, information on how its ground truth was established is not available.

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