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510(k) Data Aggregation
(248 days)
DS30 HCY HOMOCYSTEINE ASSAY KIT
In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.
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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.
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