(77 days)
The C. DIFFICILE TOX A/B II test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile in fecal specimens from persons suspected of having C. difficile disease and results should be considered in conjunction with the patient history. The test may be performed using either manual or automated (PersonalLab Junior, Adaltis U.S. Inc.) methods. FOR IN VITRO DIAGNOSTIC USE.
The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of toxins A and B in fecal specimens from patients suspected of having C. difficile disease and can be used either manually or with the Adaltis Personal Lab Jr. automated microplate analyzer system for ease of use. The subject test kit is an enzyme-linked immunoassay and has not been modified from the predicate device (K003306 and K971182). It has no technological differences from the prior 510(k) applications. The automated microplate analyzer system was not modified for use with this assay.
Here's a breakdown of the acceptance criteria and study information for the C. DIFFICILE TOX A/B II test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Not Explicitly Stated, Inferred from Results) | Reported Device Performance (Manual vs. Automated) |
|---|---|---|
| Positive sample correlation | High correlation (implied > 97%) | > 97% |
| Negative sample correlation | High correlation (implied > 99%) | > 99% |
Note: The document doesn't explicitly state "acceptance criteria" but rather presents the results of the correlation study as evidence of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, the text mentions "pre-characterized fecal samples." The exact number is not provided.
- Data Provenance: The origin of the fecal samples (e.g., country) is not mentioned.
- Retrospective or Prospective: Not explicitly stated whether the samples were collected retrospectively or prospectively. The term "pre-characterized" suggests they were likely existing samples with known C. difficile status.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the given text.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- A MRMC comparative effectiveness study was not done.
- The study described compares the performance of the manual method of the C. DIFFICILE TOX A/B II test with its automated method using the Adaltis Personal Lab Jr. It does not involve human readers interpreting results with or without AI assistance. This device is an in-vitro diagnostic test for detecting toxins, not an imaging or interpretive AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The study could be considered a form of standalone performance assessment for the automated method in comparison to the manual method. The automated system is designed to perform the assay without human interpretation of the assay's internal biochemical reactions, though a human operator would still load samples and review final results. The comparison is between two ways of running the same assay, not an AI interpreting data.
7. The Type of Ground Truth Used
- The ground truth was based on "pre-characterized fecal samples." This implies that the C. difficile status (presence or absence of toxins A and B) in these samples was previously established using a gold standard or a highly reliable method, although the specific method is not detailed (e.g., culture, another FDA-cleared test).
8. The Sample Size for the Training Set
- This information is not applicable as this device does not describe an AI or machine learning algorithm that requires a training set. The study describes the performance of a diagnostic assay being run on an automated platform.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable as this device does not describe an AI or machine learning algorithm that requires a training set with established ground truth.
§ 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.