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510(k) Data Aggregation
(393 days)
The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay used for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
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I am sorry to inform you that the provided text does not contain detailed information about the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or adjudication methods for the ALPCO Calprotectin Immunoturbidimetric Assay.
The text is primarily a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory classification, general controls, and indications for use. While it states the intended use of the assay, it does not provide the specifics of the performance study that would establish achievement of acceptance criteria.
Therefore, I cannot generate the requested table and detailed description based on the provided input. To answer your questions, I would need a different document, likely a '510(k) Summary' or the full '510(k) Premarket Notification' submission, which typically contains the detailed performance data.
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(112 days)
The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
The ALPCO Easy Stool Extraction Device is intended for use in the preparation of human stool specimens for testing in the ALPCO Calprotectin Chemiluminescence ELISA.
The ALPCO Calprotectin Chemiluminescence ELISA is performed on stool samples, collected without preservatives. After an extraction procedure of the stool sample, using either the manual weighing or Easy Extraction Device procedure, the test allows the selective measurement of calprotectin-antigen by sandwich ELISA. A monoclonal capture antibody (mAb) highly specific to the calprotectin heterodimeric and polymeric complexes, respectively, is coated onto the microtiter plate. Calibrators, controls and specimen extracts are incubated. After a washing step, a biotinylated secondary monoclonal detection antibody detects the calprotectin molecules bound to the antibody coated onto the plate. After incubation and a further washing step, a Streptavidin-Horseradish Peroxidase Enzyme conjugate binds to the available biotin on the immobilized secondary antibody. A chemiluminescent substrate is added and read when the substrate glows as a result of its oxidation with the enzyme. The signal is then read on a chemiluminescent plate reader.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the ALPCO Calprotectin Chemiluminescence ELISA and ALPCO Easy Stool Extraction Device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for all performance aspects in a unified table. However, based on the narrative, acceptance implies successful demonstration of performance within established guidelines (e.g., CLSI standards) and acceptable ranges. Here's a table summarizing the performance evaluation and implied acceptance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Within-run Precision (%CV) | Low (typ. <15-20%) | 2.6% - 5.6% (various samples) |
| Between-run Precision (%CV) | Low (typ. <15-20%) | 3.2% - 8.1% (various samples) |
| Within-day Precision (%CV) | Low (typ. <15-20%) | 4.5% - 7.9% (various samples) |
| Between-day Precision (%CV) | Low (typ. <15-20%) | 3.6% - 8.9% (various samples) |
| Total Precision (%CV) | Low (typ. <15-20%) | 5.7% - 15.5% (various samples) |
| Lot-to-Lot Reproducibility (%CV) | Low (typ. <15-20%) | 8.8% - 13.9% (various samples) |
| Site-to-Site Reproducibility (%CV) | Low (typ. <15-20%) | 9.9% - 15.0% (various samples) |
| Operator-to-Operator Reproducibility (%CV) | Low (typ. <15-20%) | 8.5% - 15.5% (various samples) |
| Extraction Method Reproducibility (%CV) | Low (typ. <15-20%) | 5.0% - 12.7% (Easy Extraction) 4.3% - 9.9% (Manual Weighing) |
| Analytical Sensitivity | ||
| Limit of Blank (LoB) | Established Value | 3.6 µg/g |
| Limit of Detection (LoD) | Established Value | 7.7 µg/g |
| Limit of Quantitation (LoQ) | Established Value | 7.9 µg/g |
| Linearity | Linear or acceptable curve fit | Linear (R² close to 1) |
| Matrix Linearity (R²) | Near 1 | 1.00 |
| Aqueous Linearity (R²) | Near 1 | 0.99 |
| Average Recovery (%) | Within acceptable range (e.g., 90-110%) | 99.2% (Matrix) & 100.6% (Aqueous) |
| Accuracy/Recovery (Spiking) | Recovery within acceptable range | 89.7% - 110.8% |
| Interfering Substances | No significant interference | Recovery 91.0 – 108.1%, no interference observed |
| Product Stability | Established stability duration | Reagents: 18 months (unopened), 7 days (opened), 14 days (transport) Raw Stool: 14 days (2-8°C, -20°C), 3 cycles (freeze/thaw) Stool Extract: 3 days (2-8°C), 14 days (-80°C), 3 cycles (freeze/thaw) |
| Stool Sample Extraction Method Comparison | Strong agreement between methods | Slope 1.014, Y-Intercept -1.296, Correlation r 0.997 (Analytical) PPA 96.2-100%, NPA 100%, TPA 98.4-100% (Qualitative) |
| Comparison with Predicate Device (Qualitative) | High agreement (PPA, NPA, TPA) | PPA 46.8-51.4%, NPA 93.1-93.6%, TPA 75.3-85.8% |
| Comparison with Predicate Device (Analytical) | Similar performance (slope, intercept, correlation) | Slope 0.6919, Y-Intercept -18.35, Correlation-r 0.784 |
| Clinical Performance (IBD vs Non-IBD) | High sensitivity, specificity, PPV, NPV | Equivocal = positive: Sensitivity 92.1%, Specificity 92.5%, PPV 72.9%, NPV 98.2% Equivocal = negative: Sensitivity 65.8%, Specificity 96.3%, PPV 79.4%, NPV 92.8% |
| Clinical Performance (IBD vs IBS) | High sensitivity, specificity, PPV, NPV | Equivocal = positive: Sensitivity 92.1%, Specificity 95.1%, PPV 92.1%, NPV 95.1% Equivocal = negative: Sensitivity 65.8%, Specificity 98.4%, PPV 96.2%, NPV 82.2% |
| Expected Values (Normal Population) | Low values for asymptomatic individuals | 130/131 samples normal/negative (< 50 µg/g) |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" implies data used for the clinical performance evaluation.
- Clinical Performance (IBD vs Non-IBD): 424 prospectively collected stool specimens. The document does not specify the country of origin for these samples. The study is prospective as it used prospectively collected specimens.
- Clinical Performance (IBD vs IBS): A subset of the above, N = 198 (76 IBD + 122 IBS patients).
- Comparison with Predicate Device: 400 samples, likely a subset of or related to the clinical performance samples, tested on both the new device and the predicate.
- Expected Values: 131 samples from apparently healthy individuals, a separate study cohort.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The ground truth for the clinical performance study (IBD diagnosis, differentiation from IBS) was established by clinical investigator/gastroenterologist(s). The document states:
- "IBD diagnosis was based on endoscopy results and/or histology of biopsies taken during the endoscopy."
- "IBS diagnosis was based on the Rome IV criteria and confirmed by negative endoscopy including the colon and terminal ileum."
The number of experts is not specified (e.g., "a single gastroenterologist" or "a panel of gastroenterologists"). Their specific experience (e.g., "10 years of experience") is also not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing the clinical ground truth (IBD/IBS diagnosis). It suggests direct diagnosis by a clinical investigator/gastroenterologist based on established clinical criteria (endoscopy, histology, Rome IV). There is no mention of independent expert review, consensus methods (e.g., 2+1), or tie-breaking procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an in vitro diagnostic (IVD) assay that aims for quantitative measurement of a biomarker, not image interpretation or a human-in-the-loop diagnostic aid. Therefore, there's no mention of human readers or "AI assistance" in the context of improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study is inherently a standalone performance evaluation of the ALPCO Calprotectin Chemiluminescence ELISA. The assay system itself processes the stool sample extracts and generates quantitative calprotectin values. Its performance (sensitivity, specificity, etc.) in aiding diagnosis is then compared against established clinical ground truth, without human-in-the-loop interaction with the assay's output during the diagnostic phase.
7. The Type of Ground Truth Used
The ground truth used for the clinical performance evaluations was a combination of:
- Clinical Diagnosis: Established by clinical investigator(s)/gastroenterologist(s).
- Endoscopy Results: Direct visualization of the GI tract.
- Histology of Biopsies: Microscopic examination of tissue samples for IBD confirmation.
- Rome IV Criteria: Standardized diagnostic criteria for functional gastrointestinal disorders like IBS.
8. The Sample Size for the Training Set
The document does not provide information on a training set for the device. As an ELISA assay, it is a biochemical test procedure rather than a machine learning algorithm that typically requires a distinct training phase with labeled data. The development of such assays involves optimization, calibration, and verification steps, but these are distinct from "training sets" in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the establishment of its ground truth is not applicable. The device's "training" or development would involve standard analytical chemistry and immunoassay development practices to optimize reagents, protocols, and ensure accurate detection and quantification of calprotectin.
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