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The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.

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This looks like a 510(k) clearance letter for the "Fetal D Tection Kit" and does not contain the detailed study information you are requesting. A 510(k) letter primarily indicates that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device.

The information you are asking for, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and study designs, would typically be found in the manufacturer's 510(k) submission document itself, or in associated study reports. These details are generally not included in the FDA's clearance letter.

Therefore, I cannot fulfill your request using only the provided text.

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