(111 days)
The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER 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 CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen. The Microassay Plate in the kit contains immobilized capture monoclonal antibodies against a Campylobacter-specific antigen. The Conjugate consists of polyclonal antibodies to a Campylobacter-specific antigen conjugated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Conjugate and to the immobilized capture antibody during the incubation phase. Any unbound material is removed during the washing steps. Following the addition of Substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of antigen.
The document describes the CAMPYLOBACTER CHEK™ test, an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. It is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it presents the reported performance from a prospective clinical study, which implicitly serves as the successful demonstration of performance for clearance. The predicate device's performance is not provided in a comparative table within the document, so a direct comparison of acceptance criteria to predicate performance isn't possible from the given text.
| Performance Metric | Reported Device Performance (CAMPYLOBACTER CHEK™ test) |
|---|---|
| Sensitivity | 91.4% |
| Specificity | 99.1% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Prospective Study): N = 1552 patients.
- Data Provenance: The prospective study was conducted at "4 independent sites." The country of origin is not explicitly stated, but the document refers to the "U.S. Formulation" for interfering substances testing, suggesting a U.S. context for the clinical studies. The data is prospective, meaning specimens were collected and tested over time.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the prospective study was primarily established by bacterial culture.
- Number of Experts: Not specified.
- Qualifications: Since traditional bacterial culture is the method, it would implicitly involve trained laboratory technologists or microbiologists. Specific qualifications (e.g., radiologist with X years of experience) are not applicable or provided in this context as it's not an imaging device.
4. Adjudication Method for the Test Set
The primary comparison was between the CAMPYLOBACTER CHEK™ test and culture. For discrepant specimens (14 culture-negative/device-positive and 3 culture-positive/device-negative), additional testing was performed at TECHLAB.
- Adjudication Method: "The 17 discrepant specimens were further characterized by additional testing at TECHLAB. This testing included 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 bidirectional sequencing." This indicates a multi-method adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that produces a qualitative result, not an imaging device requiring human reader interpretation in the context of improving diagnostic accuracy with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance reported (Sensitivity 91.4%, Specificity 99.1%) is for the CAMPYLOBACTER CHEK™ test operating as a standalone diagnostic assay. The results are read by either visual inspection or spectrophotometric means, but the performance metrics reflect the direct output of the assay compared to the reference method (culture).
7. The Type of Ground Truth Used
- Primary Ground Truth: Bacterial Culture (for the prospective study).
- Adjudication Ground Truth: For discrepant results, a combination of "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 bidirectional sequencing." This represents a form of expert consensus or multi-method confirmation based on established diagnostic techniques.
8. The Sample Size for the Training Set
The document describes performance studies, but it does not mention a training set in the context of an algorithm or machine learning model. This device is an enzyme immunoassay (EIA) kit, which is a laboratory test, not an AI/ML software device. Therefore, the concept of a "training set" for an algorithm is not applicable here. The development of the assay itself would have involved extensive R&D and optimization, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for an algorithm is not applicable to this device. Therefore, no ground truth for a training set was established in the context of AI/ML development.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).