(55 days)
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serve or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
Homogeneous Enzymic Homocysteine Reagent
The provided text is a 510(k) clearance letter from the FDA for a Homogeneous Enzymic Homocysteine Reagent. It confirms that the device is substantially equivalent to previously marketed devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The letter is a regulatory approval document and focuses on the administrative aspects of device clearance, such as classification, regulation, and marketing permission, rather than the detailed technical study results that would typically include acceptance criteria and performance data.
Therefore, I cannot provide the requested table and study details based solely on the input document.
§ 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.