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The Roche Hemoglobin A1c Control 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 HbA1c assays measuring HbA1c as a fraction of total Hemoglobin.
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This document is a 510(k) clearance letter from the FDA for a medical device called "Roche Hemoglobin A1c Control N and P." It's not a study report or a technical document describing a device and its performance in detail.
Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from this document. This letter primarily states that the FDA has found the device "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed study results or performance metrics you've asked for.
The relevant information in this document is:
- Device Name: Roche Hemoglobin A1c Control N and P
- Intended Use: 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 HbA1c assays measuring HbA1c as a fraction of total Hemoglobin.
- Regulatory Class: I
- Product Code: JJX
- Date of Clearance: August 6, 1997
- Marketing status: Cleared for marketing based on substantial equivalence.
To answer your questions about acceptance criteria and study data, you would need to access the actual 510(k) submission document (K972721) or any associated clinical/analytical study reports, which are not provided here.
§ 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.