(115 days)
The Quantase Total Galactose Screening Assay is an enzymatic colorimetric end-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 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.
enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens
The provided text is a 510(k) clearance letter from the FDA for the Quantase™ Total Galactose Screening Assay, 2000 Test Kit. This document does not contain the acceptance criteria or details of a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It mentions the intended use of the device: an enzymatic colorimetric end-point method for the determination of total D(+)galactose in dried blood spot specimens from newborn human infants as part of a newborn screening program. It also states that elevated results indicate the urgent need for further study, and the kit is not intended for monitoring galactosaemic patients or detecting ante-natal galactosaemia.
Since the provided document does not contain the requested information about acceptance criteria and study details, I cannot populate the table or answer the specific questions. A separate study report or regulatory submission document would be required to provide the information requested.
§ 862.1310 Galactose test system.
(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.