(125 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correct performance by general public | >97% |
| Lay user accuracy (general public vs. professional) | >90% |
| Accuracy (device vs. quantitative serum FSH) | >95% |
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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OCT 3 0 2003
510(k) SUMMARY
| Name of 510(k) sponsor: | Genosis Ltd.. |
|---|---|
| Address: | 12-50 Kingsgate RoadKingston Upon ThamesEngland KT2 5AA |
| Telephone: (44) 208 408 5232Fax: (44) 208 408 5432 | |
| Contact information: | Paul BatemanPresident & CEOGenosis Ltd. |
| Telephone: (44) 208 408 5246Fax: (44) 208 408 5432E-mail: paul_b@genosis.com | |
| Date summary prepared: | June 27, 2003 |
| Proprietary name of device: | Fertell Female Fertility Test |
| Generic/classification name: | Follicle Stimulating Hormone (FSH) Test, Over theCounter |
| Product code (classification): | NGA (Follicle Stimulating Hormone (FSH) Test, Over theCounter)21 C.F.R. § 862.1300 |
Legally Marketed Predicate Devices:
Instacheck Menopause Predictor Test (K023408)
Surestep FSH Menopause Test (K010556)
Genua Menopause Monitor Test Kit (K002450)
AxSYM Follicle Stimulating Hormone (K935612)
MAIAclone™ FSH Assay (K862813)
FIRST RESPONSE Ovulation Predictor Test (K953581)
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Device Description and Technological Characteristics:
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.
Intended Use
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.
Testing
The consumer study demonstrated that the Fertility Test could be accurately performed by a general public consumer population in the home environment (correct response level >97%). 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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 3 0 2003
Genosis Ltd. c/o Sharon A. Segal, Ph.D. Director of Regulatory Science Morgan, Lewis & Bockius 1111 Pennsylvania Avenue N.W. Washington, D.C. 20004
K032002 Re:
Trade/Device Name: Fertell Female Fertility Test Regulation Number: 21 CFR 862.1300 Regulation Name: Follicle-stimulating hormone test system Regulatory Class: Class I Product Code: NGA Dated: September 15, 2003 Received: September 15, 2003
Dear Dr. Segal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Genosis Ltd.
KO32002 510(k) Number:
R.S.V.P. by 2/20/23
Device Name: Fertell Female Fertility Test
Indications for Use:
Applicant:
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.
Carol Benear for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032002
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Or
Over-the Counter Use √
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.