(113 days)
The TOX A/B TEST is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.
The TOX A/B TEST is an enzyme immunoassay.
The TechLab TOX A/B TEST is an enzyme immunoassay designed for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It is intended for use with fecal specimens from individuals suspected of having C. difficile disease, serving as an aid in diagnosis, with results to be considered alongside the patient's history.
Here is the requested information regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Specificity for toxins A and B of C. difficile (or equivalent toxins of toxigenic C. sordellii) and no reaction with non-toxigenic C. difficile or normal intestinal flora/enteric pathogens. | The TOX A/B TEST is specific for toxins A and B of Clostridium difficile or the equivalent toxins of toxigenic C. sordellii. The test does not react with antigens from nontoxigenic strains of C. difficile or antigens from members of the normal intestinal flora or enteric pathogens. |
| Sensitivity | 92% |
| Specificity | 100% |
| Predictive Positive Value | 100% |
| Predictive Negative Value | 99% |
| Correlation with gold standard tissue culture test | > 98% |
| Test completion within 1 hour | Can be completed within 1 hour |
| Minimizes number of steps, easy to use | Minimizes the number of steps needed, making it easy to use. |
| Does not require an indeterminate zone | An indeterminate zone is not needed, thus simplifying the interpretation of test results. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the country of origin of the data. It also does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not described. The study focuses on the performance of the device against a gold standard, not on human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The reported sensitivity, specificity, predictive values, and correlation against a "gold standard" tissue culture test represent the standalone performance of the TOX A/B TEST.
7. Type of Ground Truth Used:
The type of ground truth used was the "gold standard" tissue culture test.
8. Sample Size for the Training Set:
The sample size for the training set is not mentioned in the provided text.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established. It only refers to the "gold standard" tissue culture test for evaluation.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.