(248 days)
In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.
Not Found
I am sorry, but the provided text from the FDA document (K982003) is a 510(k) clearance letter for a diagnostic device (DS30 Hcy Homocysteine Assay Kit), not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, the document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. These details would typically be found in the device's premarket submission or a separate validation study report, not in the clearance letter itself.
The document only specifies:
- Device Name: DS30 Hcy Homocysteine Assay Kit
- Intended Use: In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.
Without a detailed study report, I cannot provide the requested information.
§ 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.