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Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are 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. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.

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This FDA document is a 510(k) clearance letter for a medical device called "Vital Diagnostics Serum Controls." It does not contain any information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/ML medical devices.

The document states that the device is a quality control material intended to "estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation." This indicates it's a calibrator or control for other diagnostic tests, not a diagnostic device itself that directly analyzes patient data to provide a medical diagnosis.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance with the details you provided (sample size, experts, ground truth, MRMC, standalone performance, training set) because this information is not present in the provided text.

The document mainly covers:

• The 510(k) clearance number (K111063)
• The device name (Vital Diagnostics Serum Controls)
• The regulation number and name (21 CFR § 862.1660, Quality control material)
• Regulatory class (Class I reserved)
• Product codes (JJY)
• The determination of substantial equivalence to predicate devices.
• Indications for Use (as a quality control material).

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