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Abbott Liquid Assayed Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Abbott Liquid Assayed Chemistry Control" device. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria through a performance evaluation.

Therefore, I cannot extract the requested information from this document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance is considered comparable to existing, approved devices, and thus a detailed de novo study with specific acceptance criteria and performance metrics is generally not required to demonstrate safety and effectiveness for a 510(k) submission.

The document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details of a study.
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies (as this is a control solution, and not a diagnostic AI device).
• Standalone algorithm performance (again, not applicable to this type of device).
• Type of ground truth used.
• Sample size for training sets or how ground truth for training sets was established.

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