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The Roche Control Serum N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative clinical chemistry assays.

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The provided document is a 510(k) premarket notification letter from the FDA for "Roche Control Serum N (human) and P (human)". It indicates that the device has been found substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

The document states the "Indications for Use" for the device:
"The Roche Control Serum N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative clinical chemistry assays."

As this is a quality control material and not a diagnostic device itself that measures a biological parameter, the concept of "accuracy" and "precision" for this product would refer to its own stated values and consistency, which is different from clinical diagnostic performance metrics like sensitivity or specificity.

Therefore, I cannot provide the requested information from the provided text as it is not present in the document.

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