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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.

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