(12 days)
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.