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510(k) Data Aggregation
(258 days)
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
Enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgA or IgG antibodies to qliadin in human serum to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings.
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This is a 510(k) premarket notification for an immunoassay device (ImmuLisa Celiac G+ (Gliadin) IgA and IgG Antibody ELISA) and not an AI/ML device. Therefore, the provided document does not contain the specific information required to answer the prompt regarding AI/ML device acceptance criteria and study details.
The document discusses the substantial equivalence determination for a laboratory diagnostic test. It outlines the regulatory classification, product codes, and general controls for such devices, but it does not detail performance studies in the context of AI/ML algorithms.
Therefore, I cannot extract the requested information from this document.
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