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The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA) intended for the quantitative measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The LIAISON® Calprotectin assay can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome (IBS). Test results are to be used in conjunction with information obtained from the patients' clinical evaluation and other diagnostic procedures.

The test has to be performed on the LIAISON® Analyzer Family.

The DiaSorin LIAISON® Q.S.E.T. Device Plus (Quantitative Stool Extraction and Test) is intended for use in the preparation of human stool specimens for testing in the LIAISON® Calprotectin assay.

The LIAISON® Calprotectin assay is a sandwich assay that uses 2 monoclonal antibodies for capture and detection of calprotectin. The LIAISON® Calprotectin assay must be run on the LIAISON® Analyzer family, a fully automated system with continuous loading.

Calprotectin is first extracted from human stool samples with LIAISON® Q.S.E.T. Buffer using either the weigh method, the LIAISON® Q.S.E.T. Device or the LIAISON® Q.S.E.T. Device Plus. The assay incubates extracted sample, calibrator, control, or calibration verifiers with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the calprotectin heterocomplex. Following incubation, a wash cycle is performed to remove any unbound material. An isoluminol conjuqated monoclonal antibody that recognizes calprotectin is then added to the reaction and incubated. The unbound conjugate is removed with a second wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of calprotectin present in the calibrators, controls or samples.

All assay steps and incubations are performed by the LIAISON® XL Analyzer. The analyzer software automatically calculates the concentration of calprotectin in the sample. This concentration is expressed in ug/g.

The Q.S.E.T. Device Plus differs from its predicate Q.S.E.T. Device in that it is provided ready to use, and comes prefilled with the same extract buffer as required for use with the Q.S.E.T. Device, eliminating the need for the user to prepare the buffer and add it to the device themselves. In addition, minor changes to the shape and design of the tube were made.

The provided text is related to the FDA 510(k) premarket notification for the DiaSorin LIAISON® Calprotectin assay and the LIAISON® Q.S.E.T. Device Plus. None of the information requested in your prompt (Acceptance criteria, Study proving device meets criteria, Sample size, data provenance, expert numbers, etc. for AI/clinical studies) is present in the document.

The document describes an in vitro diagnostic (IVD) chemiluminescent immunoassay (CLIA) for fecal calprotectin, intended as an aid in diagnosing Inflammatory Bowel Diseases (IBD) and differentiating it from Irritable Bowel Syndrome (IBS). It also details a device for stool sample preparation.

The performance data included in the document specifically refers to the analytical performance of the IVD device and its sample preparation component, such as:

• Precision/Reproducibility: This section details the reproducibility of the LIAISON® Q.S.E.T. Device Plus extraction using five (5) stool samples with 90 measurements per sample (6 replicates over 5 days by 3 operators). It also shows sampling reproducibility using 5 human stool specimens, sampled by 3 operators with 5 replicates per specimen per operator on 3 lots of devices, totaling 225 sampling events.
• Reagent Stability: Mentions stability of the LIAISON® Q.S.E.T. Device Plus at 2-8°C for 12 months.
• Specimen Stability: Provides stability data for stool specimens under various storage conditions (refrigerated, room temperature, frozen, freeze/thaw cycles) and for sample extracts.

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/clinical study, the study setup to prove meeting those criteria, sample sizes for test/training sets in an AI context, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the analytical validation described for this IVD device.

The document solely focuses on the analytical performance validation of an IVD immunoassay, not on clinical performance or AI/machine learning aspects.

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