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The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.

The TECHLAB® ASCA-CHEK test is an enzyme-linked immunoassay (ELISA) for the measurement of human anti-S. cerevisiae antibodies in feces as an aid in the diagnosis of Crohn's disease. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. When human ASCA is present in the fecal specimen, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal ASCA is an aid in the diagnosis of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis. This noninvasive diagnostic method is simple to perform and requires only a fecal specimen for the analysis.

Here's an analysis of the provided text regarding the TECHLAB® ASCA-CHEK test, outlining the acceptance criteria and the study that demonstrated its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as clear thresholds (e.g., "sensitivity must be >X%"). Instead, the performance is compared against clinical diagnoses and against a predicate device. The document highlights the sensitivity and specificity values achieved, which implicitly serve as the demonstrated "acceptance" level for this 510(k) submission, aligning with substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set 1 (All 4 Study Sites, including healthy controls): N=353
  • Crohn's disease: 142
  • Non-Crohn's disease (Ulcerative colitis, irritable bowel syndrome, healthy persons): 211
• Test Set 2 (All 4 Study Sites, excluding healthy controls): N=285
  • Crohn's disease: 142
  • Ulcerative colitis and irritable bowel syndrome: 143
• Test Set 3 (Pediatric sites only, excluding healthy controls): N=146
  • Crohn's disease: 64
  • Ulcerative colitis and irritable bowel syndrome: 82
• Test Set 4 (Paired fecal and serum specimens vs. QUANTA Lite ASCA IgG): N=82
  • IBD (Crohn's Disease, Ulcerative Colitis): 70 (CD=47, UC=23)
  • Other (IBS, Cancer, indeterminant): 7
  • Healthy Persons: 5
• Data Provenance: The study was conducted at "four clinical sites" and included a "mixed patient population including both pediatric and adult patients." The document does not specify the country of origin, but given the contact information, it is likely the U.S. The data appears to be retrospective clinical sample collection, where the samples are then tested by the device and compared to existing clinical diagnoses.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that the test results were compared to "clinical assessments for disease diagnosis." It does not specify the number of experts, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for a diagnosis of Crohn's disease, it is generally established by gastroenterologists, often involving endoscopy, biopsy, and imaging, implying that the "clinical assessments" would be from qualified medical specialists.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by "clinical assessments for disease diagnosis." This suggests that the clinical diagnosis, as determined by the treating physicians at the four clinical sites, was directly used as the ground truth without a separate adjudication panel for the study itself.

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 done. This study is an in-vitro diagnostic (IVD) device study comparing the performance of an assay to clinical diagnosis and a predicate assay, not assessing how human readers improve with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone (algorithm only) performance study. The TECHLAB® ASCA-CHEK test is an ELISA assay; its performance is measured directly from the assay results compared to the clinical ground truth, without human-in-the-loop interaction with the device's analytical output. The "algorithm" here refers to the biochemical process and readout of the ELISA.

7. The Type of Ground Truth Used

The primary type of ground truth used was clinical diagnosis. This clinical diagnosis encompasses a broader assessment including potentially pathology, imaging, patient history, and symptomology, as determined by medical professionals. For the comparison with the predicate device, the predicate device's results (performed on serum) also served as a comparative "ground truth" to assess concordance.

8. The Sample Size for the Training Set

The document does not specify a separate training set. In the context of IVD device submissions, the performance data presented typically relates to the validation of the finalized device (the test set). If internal development or optimization involved training, that information is not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

Since no separate training set is described, the method for establishing its ground truth is also not mentioned.

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