(125 days)
Not Found
No
The device description details a simple lateral flow immunoassay with visual interpretation based on line intensity comparison. There is no mention of computational analysis, algorithms, or learning processes that would indicate AI/ML.
No
This device measures hormone levels to provide information about fertility; it does not treat any condition.
Yes
The device measures Follicle Stimulating Hormone (FSH) in urine to provide an "adjunctive screen of fertility." It indicates if FSH levels are 10 IU/L or greater, which is "indicative of diminished ovarian reserve." This information is used to assess a physiological state (fertility/diminished ovarian reserve) and aid in understanding a health condition (unsuccessful conception), fitting the definition of a diagnostic device.
No
The device description clearly outlines a physical dipstick, lateral flow rapid test that measures FSH in urine using antibodies and a nitrocellulose strip. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for measuring Follicle Stimulating Hormone ("FSH") in urine as an adjunctive screen of fertility. This involves testing a sample taken from the human body (urine) to provide information about a physiological state (fertility).
- Device Description: The description details a "dipstick, lateral flow rapid test that measures FSH in an instream urine sample." This is a classic description of an in vitro diagnostic test. It uses antibodies to detect a specific analyte (FSH) in a biological sample.
- Mechanism of Action: The mechanism involves a chemical reaction between components of the device and the urine sample to produce a result (the appearance of a line). This is characteristic of an in vitro diagnostic test.
- Comparison to Predicate Devices: The listed predicate devices are all IVDs (e.g., Menopause Predictor Tests, FSH Assays, Ovulation Predictor Tests). This further supports the classification of the Fertell Female Fertility Test as an IVD.
- Performance Studies: The performance studies describe evaluating the accuracy of the test in detecting FSH in urine samples, which is a key aspect of validating an IVD.
In summary, the Fertell Female Fertility Test meets the definition of an In Vitro Diagnostic device because it is intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes (in this case, as an adjunctive screen of fertility).
N/A
Intended Use / Indications for 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.
Product codes
NGA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use by women
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K023408, K010556, K002450, K935612, K862813, K953581
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 3 0 2003
510(k) SUMMARY
| Name of 510(k) sponsor: | Genosis Ltd.. |
|---|---|
| Address: | 12-50 Kingsgate Road |
| Kingston Upon Thames | |
| England KT2 5AA | |
| Telephone: (44) 208 408 5232 | |
| Fax: (44) 208 408 5432 | |
| Contact information: | Paul Bateman |
| President & CEO | |
| Genosis Ltd. | |
| Telephone: (44) 208 408 5246 | |
| Fax: (44) 208 408 5432 | |
| E-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 the |
| Counter | |
| Product code (classification): | NGA (Follicle Stimulating Hormone (FSH) Test, Over the |
| Counter) | |
| 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)
1
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.
2
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).
3
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
4
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 √