(77 days)
The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.
Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine. The Moments Menopause Check, like many commercially available FSH screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology.
Here's a summary of the acceptance criteria and study details for the Moments Menopause Check device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Correlation to Predicate Devices | 98% correlation | Clinical sample correlation study |
| Overall Accuracy (Lay Users) | 97% accuracy | Consumer study |
2. Sample Sizes Used for the Test Set and Data Provenance
The exact sample sizes for the clinical sample correlation study and the consumer study are not explicitly stated in the provided text.
- Data Provenance: The text indicates "Laboratory studies, using clinical specimens" and "A consumer study was also performed." This implies that the data was collected from human participants, likely in a prospective manner for the consumer study, and potentially retrospective or prospective for the clinical sample correlation study, though this is not specified. The country of origin is not mentioned, but the manufacturer is based in San Diego, California, USA, suggesting the studies likely originated there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Clinical Sample Correlation Study: The "predicate devices" were used as the comparison for establishing ground truth. The expertise involved in generating results from the predicate devices is not specified, but it's implied that these are established, commercially available tests.
- Consumer Study: The ground truth for the consumer study's accuracy (97%) is not explicitly described in terms of "experts." It refers to the device's accuracy in the hands of lay users, suggesting the "truth" against which their results were compared was likely derived from the established laboratory methods (predicate devices) on the same samples, although this is inferred.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated in the provided text for either study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focus on comparing the device to predicate devices and assessing accuracy with lay users, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance was done. The "clinical sample correlation study" and the "consumer study" directly assess the performance of the Moments Menopause Check device itself (the "algorithm" in this context refers to the device's inherent detection mechanism) without explicit human-in-the-loop assistance influencing the detection mechanism itself, beyond the user performing the test.
7. Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth was established by comparison to predicate devices. This implies the results from established, commercially available FSH screening test kits were considered the "truth."
- Consumer Study: The ground truth for the accuracy assessment against the lay user's results was likely established by laboratory methods (predicate devices) on the same samples, though this is not explicitly stated.
8. Sample Size for the Training Set
The provided text does not mention a training set or its sample size. This type of immunoassay device typically does not involve a "training set" in the machine learning sense. Performance is established through validation studies.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for this type of device, this question is not applicable.
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MAY 2 0 2004
K 040575
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
ldentification: Moments Menopause Check (Models 9111 and 9112)
Description: Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine
Name Of Manufacturer:
Phamatech 10151 Barnes Canvon Road San Diego, California 92121, USA
Intended Use: The Moments Menopause Check is a rapid, qualitative immunoassay for the detection of the FSH in urine. The minimum detectable concentration for this test is 25 mIU/ml. This assay is intended for use in the home to assist in the early detection of menopause.
The Moments Menopause Check, like many commercially available FSH Technology: screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Synova Menocheck and the Applied Biotech SureStep FSH (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target analyte / antibody / complexes.
The product performance characteristics of the TBD Menopause Check Performance: were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Moments Menopause Check to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the FSH in urine. Laboratory studies, using clinical specimens, produced a 98% correlation when compared to the predicate devices. A consumer study was also performed. In it the Moments Menopause Check exhibited excellent overall accuracy (97%) in the hands of lay users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech Moments Menopause Check is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 0 2004
Mr. Carl A. Mongiovi Vice President Phamatech, Inc. 10151 Barnes Canyon Road San Diego, CA 92121
Re: K040575
Trade/Device Name: Moments Menopause Check (Models 9111 and 9112) Regulation Number: 21 CFR 862.1300 Regulation Name: Follicle-stimulating hormone test system Regulatory Class: Class I Product Code: CGJ Dated: February 5, 2004 Received: March 16, 2004
Dear Mr. Mongiovi:
We have reviewed your Scction 510(k) promarket 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 l'edcral 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, Codc 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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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.
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): K040575
Device Name: Moments Menopause Check (Models 9111 and 9112)
Indications for Use:
The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.
Prescription Use: Part 21 CFR 801 Subpart D AND/OR
Over the Counter: X 21 CFR 807 Subpart C
Concurrence of CDRH Office of In Vitro Diagnostic Devices (OIVD)
Rate Chucker for Coral Basin
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 040575
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§ 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.