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Architect AFP MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the AFP assay on the Abbott Architect i System.

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This document is a 510(k) clearance letter from the FDA for a device called "Architect AFP MasterCheck". It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML diagnostic devices.

Instead, this letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The "indications for use" state that the device is "intended for use in the verification of sensitivity, calibration linearity, and reportable range of the AFP assay on the Abbott Architect i System." This strongly suggests that the device in question is a quality control material or calibrator for another assay system, not a diagnostic device that directly produces patient results.

Therefore, the specific information requested in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) is not applicable to this document. These details are typically found in study reports for diagnostic algorithms, not 510(k) clearance letters for quality control materials.

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