(216 days)
This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease.
Not Found
The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter from the FDA to Wallac, Inc. for their Neonatal Leucine Test Kit.
The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, it does not describe the specific performance, acceptance criteria, or a study that directly demonstrates the device meets these criteria.
Therefore, I cannot provide the requested information based on the given text.
§ 862.1555 Phenylalanine test system.
(a)
Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.(b)
Classification. Class II.