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Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.

Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.

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The provided text describes a 510(k) premarket notification for "Data-Trol A Abnormal Control Serum" and "Data-Trol N Normal Control Serum." This document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices.

However, the document is a regulatory approval notice and does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in points 1-9 of your prompt.

The FDA 510(k) process for these types of Class I devices often relies on demonstrating substantial equivalence to existing devices through comparative data (e.g., performance characteristics like accuracy and precision compared to a predicate) rather than requiring a detailed clinical study with the specifics you're asking for. For a quality control material, the "performance" typically refers to its ability to serve as a stable, known sample for monitoring laboratory test procedures.

To address your request, I would need a different type of document, such as a study report, validation protocol, or a more detailed technical submission from the manufacturer.

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