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This kit is intended for quantifying human IgA subclasses 1 and 2 in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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I apologize, but the provided text from the FDA 510(k) letter for the "Human IgA Subclass BNII Combi Kit" (K981912) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

This document is a letter from the FDA indicating substantial equivalence for a medical device, which means the device is deemed as safe and effective as a legally marketed predicate device. While it mentions the device's intended use and classification, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size, data provenance, number and qualifications of experts, adjudication method for a test set.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specifics on the type of ground truth used, training set sample size, or how the training set's ground truth was established.

These types of details would typically be found in the original 510(k) submission document or supporting studies, which are not included in this letter. The letter itself is a regulatory approval notice, not a summary of the underlying performance studies.

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