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510(k) Data Aggregation
(48 days)
BUHLMANN fCAL ELISA
The BÜHLMANN fCAL® ELISA is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool. The BÜHLMANN fCAL® ELISA 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 fCAL® ELISA is an enzyme-linked immunosorbent assay (ELISA) performed using patient stool extracts collected without preservatives. Calprotectin within the extract binds to protein specific antibodies coated on the well surface. An enzyme conjugated antibody detects the captured antigen. Incubation of the complex with substrate results in a colored product which reflects the amount of calprotectin in the sample. Quantification of calprotectin concentration is achieved using standard plate readers.
The provided document describes the BÜHLMANN fCAL® ELISA, an in vitro diagnostic assay for the quantitative measurement of fecal calprotectin in human stool. The device aids in the diagnosis of inflammatory bowel disease (IBD) and differentiation of IBD from irritable bowel syndrome (IBS).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct, quantifiable targets in the provided text. Instead, the document presents performance study results. The "Clinical Thresholds" section (page 7) outlines the device's interpretation zones, which serve as criteria for classifying results.
| Acceptance Criteria Category | Reported Device Performance (BÜHLMANN fCAL® ELISA) |
|---|---|
| Clinical Thresholds | 160 µg/g: Elevated |
| Precision (Repeatability - Single-site) | P1 (38.5 µg/g): Total %CV 9.4% |
| P2 (67.0 µg/g): Total %CV 6.4% | |
| P3 (135.7 µg/g): Total %CV 4.4% | |
| P4 (207.1 µg/g): Total %CV 6.4% | |
| P5 (337.1 µg/g): Total %CV 5.7% | |
| P6 (562.6 µg/g): Total %CV 3.1% | |
| P7 (918.0 µg/g): Total %CV 7.4% | |
| Precision (Reproducibility - Multi-site) | S01 (41.4 µg/g): Total %CV 23.2% |
| S02 (67.2 µg/g): Total %CV 13.0% | |
| S03 (143.0 µg/g): Total %CV 12.1% | |
| S04 (379.8 µg/g): Total %CV 6.4% | |
| S05 (1056.6 µg/g): Total %CV 9.8% | |
| Precision (Lot-to-Lot Reproducibility) | Sample 2 (46.4 µg/g): Total %CV 9.7% |
| Sample 3 (105.5 µg/g): Total %CV 4.2% | |
| Sample 4 (133.6 µg/g): Total %CV 5.4% | |
| Sample 5 (178.5 µg/g): Total %CV 5.2% | |
| Sample 6 (435.2 µg/g): Total %CV 5.3% | |
| Sample 7 (1476.1 µg/g): Total %CV 7.5% | |
| Precision (Extraction Reproducibility) | Sample (51.2 µg/g): Total %CV 8.9% (reported as 7.8 for Total %CV in S01 row) |
| Sample S03 (88.3 µg/g): Total %CV 16.8% | |
| Sample S05 (66.8 µg/g): Total %CV 16.7% | |
| Sample S06 (179.3 µg/g): Total %CV 20.5% | |
| Sample S07 (366.1 µg/g): Total %CV 10.7% | |
| Sample S08 (327.4 µg/g): Total %CV 9.5% | |
| Sample S09 (1783.7 µg/g): Total %CV 18.4% | |
| Linearity | Analytical measuring range: 30 – 1800 µg/g |
| Accuracy/Recovery | Recovery rates typically between 96.4% and 102.2% |
| Analytical Sensitivity | LoB = 8.3 µg/g, LoD = 12.6 µg/g, LoQ = 30 µg/g |
| Clinical Sensitivity/Specificity (IBD vs. non-IBD, Borderline Positive) | Sensitivity = 93.3% (95% C.I. 87.7%, 96.9%) |
| Specificity = 70.3% (95% C.I. 63.5%, 76.5%) | |
| PPV = 67.7% (95% C.I. 60.5%, 74.4%) | |
| NPV = 94.0% (95% C.I. 89.0%, 97.2%) | |
| Clinical Sensitivity/Specificity (IBD vs. non-IBD, Borderline Negative) | Sensitivity = 84.4% (95% C.I. 77.2%, 90.1%) |
| Specificity = 83.7% (95% C.I. 77.8%, 88.5%) | |
| PPV = 77.6% (95% C.I. 69.9%, 84.0%) | |
| NPV = 88.9% (95% C.I. 83.6%, 93.0%) | |
| Clinical Sensitivity/Specificity (IBD vs. IBS, Borderline Positive) | Sensitivity = 93.3% (95% C.I. 87.7%, 96.9%) |
| Specificity = 72.3% (95% C.I. 63.8%, 79.8%) | |
| PPV = 77.8% (95% C.I. 70.6%, 83.9%) | |
| NPV = 91.3% (95% C.I. 84.1%, 95.9%) | |
| Clinical Sensitivity/Specificity (IBD vs. IBS, Borderline Negative) | Sensitivity = 84.4% (95% C.I. 77.2%, 90.1%) |
| Specificity = 85.4% (95% C.I. 78.1%, 91.0%) | |
| PPV = 85.7% (95% C.I. 78.6%, 91.2%) | |
| NPV = 84.1% (95% C.I. 76.7%, 89.9%) |
2. Sample size used for the test set and the data provenance
- Clinical Study (IBD vs. non-IBD):
- Sample Size: 337 total samples (135 IBD, 202 non-IBD).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- Clinical Study (IBD vs. IBS):
- Sample Size: 265 total samples (135 IBD, 130 IBS).
- Data Provenance: Not explicitly stated.
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 method for establishing ground truth (e.g., clinical diagnosis by a panel of specialists) is not detailed.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a diagnostic assay (ELISA), not an AI-assisted imaging device requiring human-in-the-loop interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire performance evaluation described for the BÜHLMANN fCAL® ELISA is inherently a standalone (algorithm only) performance study. The device provides a quantitative measurement of fecal calprotectin without human interpretive input in the assay process itself. The clinical sensitivity and specificity evaluate the performance of this standalone measurement against a clinical diagnosis.
7. The type of ground truth used
The ground truth for the clinical studies appears to be clinical diagnosis. The sections "Clinical Sensitivity/Specificity of IBD vs. non-IBD" and "Clinical Sensitivity/Specificity of IBD vs. IBS" compare the device's results to "IBD," "non-IBD," and "IBS" classifications, which are clinical diagnoses.
8. The sample size for the training set
This information is not provided in the document. As this is a diagnostic assay, not a machine learning model, the concept of a "training set" in the typical sense of AI model development may not directly apply. However, method development and optimization would have involved internal samples, but their size and nature are not disclosed as a "training set."
9. How the ground truth for the training set was established
This information is not provided in the document.
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