(356 days)
The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.
Triglycerides are hydrolyzed by lipoprotein lipase to glycerol and fatty acid. Glycerol is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP) forming glycerol-3-phosphate and adenosine-5-diphosphate (ADP). The glycerol-3phosphate is oxidized by glycerophosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. In the presence of peroxide, peroxidase catalyzes the coupling of 4-AAP (4-aminoantipyrine) with an N,N-disubstituted aniline to form a quinoneimine dye.
I am sorry but the provided text does not contain detailed information about acceptance criteria, study methodologies, or specific performance metrics that would allow me to populate the requested table and answer all the questions about a study proving device acceptance. The document primarily focuses on the 510(k) submission, intended use, device description, and a comparison to a predicate device for substantial equivalence. It does not include a clinical study report or performance data against specific acceptance criteria.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.