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510(k) Data Aggregation
K Number
K032002Device Name
FERTELL FEMALE FERTILITY TEST
Manufacturer
GENOSIS, INC.
Date Cleared
2003-10-30
(125 days)
Product Code
NGA
Regulation Number
862.1300Why did this record match?
Applicant Name (Manufacturer) :
GENOSIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
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