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The Quantase Total Calactose Screening Assay is an enzymatic colorimetric cad-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme.

The test is intended as a screening measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received.

The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.

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The provided text is a 510(k) clearance letter from the FDA for the "Quantase Total Galactose Screening Assay 500 Test Kit." It confirms substantial equivalence to a legally marketed predicate device but does not contain a detailed study report or specific acceptance criteria and performance data for the device itself.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study types (MRMC, standalone) because this information is not present in the provided document. The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed technical study analysis.

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