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The San Diego Biotech HCG Pregnancy Dipstick Test is intended for the qualitative determination of human chorionic gonadotropin (hCG), in urine for early detection of pregnancy. This test is intended for professional and Laboratory use only.

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This document is a 510(k) clearance letter for the San Diego Biotech HCG Pregnancy Dipstick Test and does not contain detailed information about the acceptance criteria and study proving device performance. The letter confirms substantial equivalence to a predicate device but does not include the specifics of the performance study that would show how the device meets acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

To answer your request, I would need a different document, such as the 510(k) summary or the actual performance study report submitted by San Diego Biotech.

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The San Diego Biotech HCG Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. THIS TEST IS INTENDED FOR PROFESSIONAL AND LABORATORY USE ONLY.

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I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an indication for use statement for the San Diego Biotech hCG Pregnancy Test. It does not include information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This information would typically be found in the device's 510(k) premarket notification or associated technical documentation, which is not provided in the input.

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