(35 days)
The Diazyme Homocysteine Enzymatic Assay is intended for the in vitro quantitative determination of total L-homocysteine in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Not Found
I am sorry, but after reviewing the provided document, I cannot find the specific information required to complete the table and answer all the questions regarding the acceptance criteria, study details, and ground truth establishment for the Diazyme Homocysteine Enzymatic Assay.
The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. While it mentions the "Indications for Use," it does not provide details about:
- Specific acceptance criteria values.
- The study design, results, or device performance against those criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Details about experts, adjudication methods, or ground truth establishment.
- Information on MRMC studies or standalone algorithm performance.
Therefore, I cannot extract the requested information from this 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.