(204 days)
EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.
Rapid Membrane ImmunoAssay
The provided document is a 510(k) premarket notification letter from the FDA for the EarlyDETECT® MENOPAUSE TEST. This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can, therefore, be marketed subject to general controls provisions. It specifies the device name, regulation number, regulation name, and product code, along with its intended use as a qualitative rapid membrane immunoassay for in vitro diagnostic detection of follicle-stimulating hormone (FSH) in human urine for confirming hormone changes related to menopause, intended for professional and Over-The-Counter (OTC) use.
Therefore, I cannot provide the requested information based on the text provided. A separate submission, often referred to as the 510(k) summary or the full 510(k) submission, would typically contain such detailed study information.
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Public Health Service
JUL 3 0 2003
Food and Drug Administration 2098 Gaither Fload Rockville MD 20850
Mr. Peter George CEO Early Detect, Inc. 2950 North Glassell Street Orange, CA 92865
Re: K030058
Trade/Device Name: EarlyDETECT® MENOPAUSE TEST Regulation Number: 21 CFR 862.1300 Regulation Name: Follicle-stimulating hormone test system Regulatory Class: Class I Product Code: CGJ Dated: April 24, 2003 Received: May 7, 2003
Dear Mr. George:
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 (OS) 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,
Steven Sutman
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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510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
EarlyDETECT® MENOPAUSE TEST Device Name:
Rapid Membrane ImmunoAssay
Indications For Use:
EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Torres
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030658
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.