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The Randox Laboratories Limited Iron Test Kit is an in vitro diagnostic reagent for the quantitative determination of iron in human serum. The method is based on the reaction of ferrous iron with the chromogen ferrozine to produce a coloured chromophore which can be detected at 570nm. Serum iron may be used to distinguish between different types of anaemias and to identify conditions involving iron deficiency. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

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The provided text is a 510(k) clearance letter from the FDA for the "Randox Iron II" device (K974604), a diagnostic reagent for the quantitative determination of iron in human serum. This type of document, particularly from 1998, focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for de novo approval.

Therefore, the document does not contain the information requested in points 1 through 9. It does not describe:

• Specific acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy.
• The sample size or provenance of a test set.
• The number or qualifications of experts used for ground truth.
• Any adjudication methods.
• Results from multi-reader multi-case (MRMC) studies or the effect size of AI assistance.
• Standalone algorithm performance.
• The type of ground truth used (pathology, expert consensus, etc.).
• The sample size or ground truth establishment for a training set.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices based on the information provided in the 510(k) submission, and it outlines regulatory requirements for marketing the device. For the detailed study information requested, one would need to consult the original 510(k) submission document itself, which is not provided here.

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