(210 days)
The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BUHLMANN fCAL® turbo.
The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay (PETIA), is performed using patient stool extracts collected without preservatives. Calprotectin within the sample extract mediates immunoparticle agglutination; sample turbidity is proportional to calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation of an established calibration curve. The assay is validated for use on clinical chemistry analyzers such as the Roche cobas® c501/c502 platforms.
The BÜHLMANN fCAL® turbo Reagent Kit is to be used in conjunction with the BÜHLMANN fCAL® turbo Calibrator Kit and BÜHLMANN fCAL® turbo Control Kit, which are available separately.
Sample extracts may be prepared using manual weighing extraction methods or the CALEX® Cap.
The CALEX® Cap is a single use tube filled with extraction buffer. The sampling pin houses a dosing tip which is used to obtain sufficient stool sample for the extraction process. The extraction method leads to stool specimen extracts which can be measured directly using the BÜHLMANN fCAL® turbo assay.
The document discusses the BÜHLMANN fCAL® turbo and CALEX® Cap devices, which are used for quantitative measurement of fecal calprotectin. The primary purpose of this submission is to extend the stability of CALEX® Cap extracts.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it refers to a "risk assessment" and a "stability study conducted in accordance with CLSI EP25 to support the shelf-life extension of the CALEX® Cap extracts." The conclusion states that "The stability study supports the claimed extension to CALEX® Cap extract shelf-life." This implies that the performance in the stability study met the internal acceptance criteria established based on the risk assessment and CLSI EP25 guidelines.
2. Sample size used for the test set and the data provenance
The document states, "an extract stability study was conducted in accordance with CLSI EP25." However, it does not provide details on the specific sample size, country of origin of the data, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study mentioned is a stability study, not a clinical study involving human experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set
This information is not provided as the study is a stability study, not a diagnostic accuracy study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not performed, nor is it applicable to this device. The BÜHLMANN fCAL® turbo is an in vitro diagnostic (IVD) assay for measuring a biomarker, not an AI-assisted diagnostic imaging or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of an immunoassay device. The BÜHLMANN fCAL® turbo is a laboratory test, and its performance is evaluated based on its analytical accuracy and precision in quantifying fecal calprotectin. There is no "algorithm only" performance separate from the assay itself.
7. The type of ground truth used
For the stability study, the "ground truth" would be the known and stable concentration of calprotectin in the samples used, measured at multiple time points to assess the stability of the extract over time. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic accuracy study.
8. The sample size for the training set
This information is not provided and is not applicable in the context of this submission. The submission is about extending the shelf-life of an existing device, which involves stability testing, not the development of a new algorithm requiring a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
§ 866.5180 Fecal calprotectin immunological test system.
(a)
Identification. A fecal calprotectin immunological test system is anin vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use 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.(b)
Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).