(119 days)
Teco Enzymatic Homocysteine Assay is in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.
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I am sorry, but the provided text does not contain the information required to answer your request. The document discusses regulatory approval for a medical device (Teco Enzymatic Homocysteine Assay) but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. It is a letter of substantial equivalence from the FDA, not a study report.
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.