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This FDA letter is a 510(k) clearance for a device called "CAMPYLOBACTER QUIK CHEK". It confirms that the device is substantially equivalent to a legally marketed predicate device. This type of letter does not contain the detailed study information required to answer your questions.

To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) summary, clinical study reports, or performance data submitted by Techlab, Inc. and reviewed by the FDA. The information you're asking for would typically be found in those documents, not in the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

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The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The CAMPYLOBACTER QUIK CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen in human fecal samples. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies against a Campylobacter-specific antigen. The control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibodies to a Campylobacter-specific antigen coupled to horseradish peroxidase. To perform the test, a fecal specimen is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, the Campylobacter-specific antigens in the sample bind to the antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-Campylobacter antibodies in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "T" reaction is examined visually for the appearance of a vertical blue line. A blue line indicates a positive "C" reaction, indicated by a vertical blue line, monitors/confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay and that the results are valid.

The document describes the performance of the CAMPYLOBACTER QUIK CHEK™ test, a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the reported performance relative to a "gold standard" (culture followed by further confirmation for discrepant results). While explicit numerical acceptance criteria are not stated for sensitivity and specificity in the provided text, the reported performance is presented as the device meeting the equivalency with the predicate and performing as well or better than standard culture.

Additional performance aspects that were evaluated include:

• Analytical Sensitivity (LoD): Established at various CFU/mL and CFU/test for C. jejuni and C. coli in raw fecal samples and different transport media.
• Analytical Specificity (Cross-Reactivity): No interference found with a broad panel of common intestinal organisms and viruses.
• Inclusivity: Found to be reactive with several tested strains of C. coli and C. jejuni (including C. jejuni sub-species doylei).
• Reproducibility: 100% correlation in results across different labs, technicians, and kit lots, with expected results 100% of the time.
• Prozone Effect: No prozone effect observed at high antigen concentrations.

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

• Sample Size (Prospective Study): 1552 patients.
• Data Provenance (Prospective Study): The study was conducted at 4 independent sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and U.S. formulation information is mentioned for interfering substances, implying a U.S. context. The study was prospective, as it involved "Prospective incoming fecal specimens collected and tested."
• Sample Size (Retrospective Study): 30 specimens.
• Data Provenance (Retrospective Study): The data provenance (country) for the retrospective specimens is not specified. The study was retrospective.

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

The ground truth for the primary clinical performance comparison (prospective study) was established by culture. While culture is a standard method, the text does not mention the number or qualifications of experts involved in performing or interpreting the initial culture results.

For the discrepant specimens (14 from the prospective study and 30 from the retrospective study), further characterization was performed using:

• An FDA-cleared commercial Microassay well EIA
• An FDA-cleared commercial molecular test
• In-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification, and species-specific identification for the retrospective study)
• Bidirectional sequencing

The number of experts involved in interpreting these additional confirmatory tests or establishing a final consensus ground truth for discrepants is not specified in the document, nor are their qualifications.

4. Adjudication Method for the Test Set

For the initial 1552 prospective specimens, the comparison was directly between the CAMPYLOBACTER QUIK CHEK™ test and culture.

For the 14 discrepant specimens (culture negative/device positive, or culture positive/device negative) from the prospective study, an adjudication method was used by referring them for additional testing with multiple methods (commercial EIA, commercial molecular test, in-house PCR, bidirectional sequencing) at TECHLAB. The results of these additional tests were used to "confirm" the status of the discrepant samples. For example, 9 out of 13 culture negative/device positive samples were confirmed positive by all additional test methods. This suggests a form of consensus or comprehensive secondary testing was used to re-evaluate the true status of these discrepant cases. The specific consensus rule (e.g., majority vote, all methods agree) is not explicitly detailed.

For the 30 retrospective specimens, all were initially Campylobacter spp. culture positive and were "further characterized as Campylobacter spp. positive by an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR... and bidirectional sequencing." This indicates a multi-method confirmation process for the ground truth of these samples before being tested retrospectively by the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) assay for antigen detection, not an AI-powered image analysis or diagnostic aid for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone Study Was Done

Yes, a standalone study was performed ("algorithm only without human-in-the-loop performance"). The entire performance evaluation, including the prospective and retrospective studies, analytical sensitivity, specificity, inclusivity, and prozone, evaluates the performance of the CAMPYLOBACTER QUIK CHEK™ test device itself. The primary clinical performance (sensitivity and specificity) is presented for the device's ability to detect the target antigen compared to culture.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical performance evaluation (prospective study) was bacterial culture.

For discrepant samples, the ground truth was further refined and confirmed by multiple orthogonal laboratory methods, including an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR, and bidirectional sequencing. This can be considered a form of expert consensus derived from multiple confirmatory tests.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This is likely because the CAMPYLOBACTER QUIK CHEK™ test is a traditional immunoassay device, not an AI/machine learning model that typically requires a large training dataset. The studies described are for validation and performance evaluation of the manufactured device.

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

As no training set is mentioned for an AI/machine learning model, this question is not applicable.

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