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The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. 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 ASCA-CHEK test is an ELISA for the measurement of human anti-S. cerevisiae antibodies in feces and serum as an indicator of Crohn's disease in combination with other clinical and laboratory findings. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. For feces, a specimen dilution of 1:10 and an OD 450 cut-off ≥0.150 or OD450620 ≥0.110 are used for the analysis. For serum, a specimen dilution of 1:1000 and an OD450 cut-off ≥0.110 or OD450620 ≥0.080 are used for the analysis. When human ASCA is present in fecal or serum specimens, 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 and serum ASCA is an indicator of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis and IBS. This diagnostic method offers a simple to perform assay that may be used with either fecal or serum specimens.

Here's a breakdown of the ASCA-CHEK device's acceptance criteria and the study that supports it, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) that the device had to meet to be approved. Instead, it presents the performance data and then asserts that, based on these findings, the device is substantially equivalent. Therefore, the "acceptance criteria" inferred here are based on the reported "substantial equivalence" claim relative to the predicate devices.

*Note: The document references "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic" for these agreement percentages, suggesting these values were deemed acceptable for demonstrating equivalence.

2. Sample Size and Data Provenance

• Sample Sizes Used for the Test Set:

  • All Patients plus Controls: N = 351 (for ASCA-CHEK vs Disease)
  • Adult Patients plus Controls: N = 215 (for ASCA-CHEK vs Disease)
  • Pediatric Patients plus Controls: N = 136 (for ASCA-CHEK vs Disease)
  • Comparison to QUANTA Lite™ ASCA (overlapping groups): N = 274 (All), N = 138 (Adult), N = 136 (Pediatric)

• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "Site: Pediatric Patients plus Controls" and "Site: Adult Patients plus Controls," implying data collection from specific clinical locations, but further details are not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing the ground truth (diagnosis of Crohn's disease or control status). The "Disease" categorization likely stems from standard clinical diagnostic criteria and specialist evaluation, but the specifics are not detailed.

4. Adjudication Method

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA), not an imaging or interpretation-based diagnostic that would typically involve multiple human readers. The study compares the performance of the new device (ASCA-CHEK) against the known disease state and against predicate ELISA devices.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "ASCA-CHEK vs Disease" rows in the performance table represent the standalone performance of the algorithm (the ASCA-CHEK ELISA) in detecting true positive and true negative cases based on a clinical diagnosis of the disease or healthy control status.

7. Type of Ground Truth Used

The ground truth used is "Disease" status, which, in the context of diagnosing Crohn's disease, would typically be established by a combination of clinical findings, endoscopy, imaging, histology (pathology), and other laboratory tests. The document indicates the ASCA-CHEK test result is "an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings," implying that there's a reference standard (the "Disease" column) against which the device's output is compared. It is not explicitly stated if it was expert consensus, pathology alone, or outcomes data, but likely a clinical diagnosis based on established medical criteria.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is typical for a 510(k) submission where the primary focus is on demonstrating clinical performance and substantial equivalence of the finished device rather than detailing model development or training data. Being an ELISA, it might not have a "training set" in the sense of a machine learning algorithm.

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

As no training set is described, this information is not provided in the document.

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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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AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings.

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is an aid in the diagnosis of Crohn`s disease and should be used in conjunction with other serological tests and clinical findings.

solid phase enzyme immunoassay (ELISA) employing purified mannan

The provided text does not contain detailed information about acceptance criteria for device performance or the specifics of a study conducted to prove the device meets such criteria. The document is an FDA 510(k) clearance letter for the AESKULISA ASCA-A and AESKULISA ASCA-G devices, indicating that they were found substantially equivalent to predicate devices. It focuses on regulatory aspects rather than detailed performance study results.

Therefore, I cannot provide the requested information in the structured format because the content is not present in the given document.

Missing Information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If standalone (algorithm only) performance was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA. It approves a device based on substantial equivalence to an existing predicate device, but it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information from this document. The letter is a regulatory approval, not a scientific study report.

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An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).

An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA.

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is typically found in the technical documentation submitted with the 510(k) application, not in the clearance letter itself.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable to an ELISA diagnostic kit in this context, but also not available.
6. If a standalone performance (algorithm only) was done: Not applicable to an ELISA kit, but also not available.
7. The type of ground truth used: Not explicitly stated for the studies.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states the "Indications For Use" which is: "An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD)." This is the purpose of the device, but not its performance metrics or study details.

To get the information you are seeking, you would need to refer to the actual 510(k) submission documentation or scientific publications related to the ImmuLisa ASCA IgA ELISA, which are not provided here.

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An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).

An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).

This is a fantastic request that requires careful reading and understanding of the provided text. Unfortunately, the provided document is a 510(k) clearance letter from the FDA, and does not contain the detailed study information you are asking for.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the Immulisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgG ELISA device received clearance based on its substantial equivalence to a previously approved device, not necessarily on a de novo study reporting detailed acceptance criteria and performance against those criteria as you've requested for an AI/device study.

For a 510(k) clearance based on substantial equivalence, the manufacturer typically provides analytical and often some clinical performance data to demonstrate that their new device performs as well as the predicate device. However, the specific format and level of detail about acceptance criteria, sample sizes, expert adjudication, etc., as you've outlined, are usually found in comprehensive study reports or regulatory submissions, which are not part of this public 510(k) clearance letter.

Therefore, I cannot extract the information you've requested from the provided text.

To answer your prompt with the requested details, you would typically need access to the full 510(k) submission document (which is usually proprietary unless specifically released or referenced in public databases) or published studies by the manufacturer.

Summary of why the information cannot be provided from the given text:

• Type of Document: This is an FDA 510(k) clearance letter, confirming "substantial equivalence," not a detailed study report.
• Basis for Clearance: Substantial equivalence relies on comparison to a predicate device, not necessarily a new, standalone clinical trial defining and hitting novel acceptance criteria in the way you've described.
• Missing Details: The letter does not contain:
  • Specific acceptance criteria values.
  • Reported device performance metrics against those criteria.
  • Sample sizes for test sets or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Information on MRMC comparative effectiveness studies.
  • Details on standalone performance.
  • How ground truth was established for training or test sets.

I apologize that I cannot fulfill your request with the provided material, as the necessary information is simply not present in this type of regulatory correspondence.

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