(58 days)
Models 9111, 9112
Not Found
No
The description focuses on a standard immunoassay for FSH detection and does not mention any AI/ML components or algorithms.
No
This device is an in-vitro diagnostic screen used to detect FSH in urine and provides a preliminary screening result, rather than providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that "The Moments Menopause Check is an in-vitro diagnostic screen." Additionally, it aims to detect a biomarker (FSH) to associate with a change in a physiological state (menopause), which is a diagnostic purpose.
No
The device is described as an "in-vitro diagnostic screen" and an "Immunoassay for the qualitative detection of FSH in urine," which are descriptions of a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it is an "in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body (like urine) to detect diseases, conditions, or states of health.
- Device Description: It describes an "Immunoassay for the qualitative detection of FSH in urine," which is a common type of IVD test.
- Anatomical Site: It specifies "Urine," which is a biological sample used in IVD testing.
- Performance Studies: The document details performance studies using clinical samples and comparing the device to predicate devices, which is standard practice for demonstrating the performance of an IVD.
- Key Metrics: It provides key metrics like correlation and accuracy, which are used to evaluate the performance of IVD tests.
The information provided clearly indicates that this device is designed to be used outside of the body (in vitro) to diagnose or screen for a condition (changes in menopause associated with FSH levels) using a biological sample (urine).
N/A
Intended Use / Indications for Use
The Moments Menopause Check is a rapid, qualitative immunoassay for the detection of follicle stimulating hormone (FSH) in urine. The minimum detectable concentration for this test is 25 mlU/ml. This assay is intended for use in the home to assist in the early detection of menopause.
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 menopause. This kit provides a preliminary test result and is intended for over-the-counter sales.
Product codes
CGJ
Device Description
Immunoassay for the qualitative detection of FSH in urine.
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
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 product performance characteristics of the Moments Menopause Check 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 follicle stimulating hormone 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. Consumer interpretation of the FSH test showed accuracy to be greater than 98%.
Key Metrics
accuracy to be greater than 98%
Predicate Device(s)
Phamatech (San Diego, CA) Moments Menopause Check (Models 9111 and 9112), Estroven Menopause Monitor
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.
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K 043599
product for over the counter use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the products and their appropriateness for commercial distribution.
FEB 2 5 2005
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: Moments Menopause Check Model 9113
Description: Immunoassay for the qualitative detection of FSH in urine.
Name Of Manufacturer:
Phamatech 10151 Barnes Canyon Road San Diego, California 92121, USA
Intended Use: The Moments Menopause Check is a rapid, qualitative immunoassay for the detection of follicle stimulating hormone (FSH) in urine. The minimum detectable concentration for this test is 25 mlU/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 tests, qualitatively measures the presence of follicle stimulating hormone by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech (San Diego, CA) Moments Menopause Check (Models 9111 and 9112) and the Estroven Menopause Monitor (Distributed by Amerifit Nutrition, Inc. Bloomfield, CT). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / FSH / colored (labeled) antibody complexes.
The product performance characteristics of the Moments Menopause Performance: Check 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 follicle stimulating hormone 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. Consumer interpretation of the FSH test showed accuracy to be greater than 98%
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 5 2005
Mr. Carl Mongiovi Vice President Phamatech, Inc. 10151 Barnes Canyon Road San Diego, CA 92121
K043599 Re:
Trade/Device Name: Moments Menopause Check (Model 9113) Regulation Number: 21 CFR 862.1300 Regulation Name: Follicle-stimulating hormone test system Regulatory Class: Class I Product Code: CGJ Dated: February 14, 2005 Received: February 17, 2005
Dear Mr. Mongiovi:
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 commercc 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 vour 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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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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Jean M. Cooper MS, DUM
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): _K043599
Device Name: Moments Menopause Check (Model 9113)
Indications for Use:
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Prescription Use:_____________________________________________________________________________________________________________________________________________________________ Part 21 CFR 801 Subpart D
Over the Counter_ AND/OR 21 CFR 807 Subpart C
Concurrence of CDRH Office of In Vitro Diagnostic Devices (OIVD)
_
Division Sign-off
Division Sign-off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K043599