(252 days)
The ZEUS ELISA Borrelia VLSe-1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.
Not Found
This FDA 510(k) clearance letter pertains to the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System. However, the provided document does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a 510(k) summary (which is a separate document). The letter primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.
Therefore, I cannot fulfill most of your request directly from the provided text. To answer your questions, I would need access to the 510(k) summary for K113397.
Based only on the provided document, here's what can be inferred or stated about what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Information in document: Not present.
- Missing: The specific clinical performance acceptance criteria (e.g., sensitivity, specificity thresholds) and the actual performance metrics achieved by the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System are not provided in this regulatory letter.
2. Sample Size Used for the Test Set and Data Provenance
- Information in document: Not present.
- Missing: The number of samples used in the clinical studies to evaluate the device and details about their origin (e.g., country, retrospective/prospective collection) are not included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Information in document: Not present.
- Missing: This document does not describe the methodology for establishing ground truth, including the number or qualifications of experts involved.
4. Adjudication Method for the Test Set
- Information in document: Not present.
- Missing: Details on how discrepancies in ground truth establishment (if applicable) were resolved are not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Information in document: Not present.
- Missing: This type of study is more common for imaging devices where human interpretation is a key component. For an ELISA diagnostic kit, a MRMC study involving human readers comparing performance with and without AI assistance is generally not applicable, as the device output is typically quantitative or qualitative (positive/negative) and does not involve human interpretation of complex images or data fields that an AI might augment. Therefore, no effect size of human readers improving with AI vs. without AI assistance would be relevant or found for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Information in document: The device is a "Test System" (ELISA kit), implying it functions as a standalone diagnostic tool.
- Implied: Yes, the performance of an ELISA kit is inherently standalone, as it produces a result based on the chemical reaction, not on human interpretation or an "algorithm" in the AI sense. Its "performance" refers to its analytical and clinical accuracy in detecting antibodies.
7. The Type of Ground Truth Used
- Information in document: The "Indications for Use" section states: "All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi." Also, "Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data."
- Inferred based on typical Lyme disease diagnostics: For validating a Lyme disease ELISA, the ground truth for patient samples would typically be established by a combination of:
- Clinical diagnosis: Based on patient history, symptoms (e.g., erythema migrans), and other clinical findings.
- Confirmatory laboratory tests: Often a 2-tier testing algorithm as described, where initial screening (like this ELISA) is followed by a Western Blot (which is a more specific confirmatory test) and potentially other specialized tests.
- Seroprevalence in endemic vs. non-endemic populations: Using panels from confirmed Lyme patients and healthy controls from both endemic and non-endemic areas.
- Reference standard panels: From organizations like the CDC or NIBSC that provide well-characterized samples.
- Missing: The specific "ground truth" definition used for the clinical study that supported this 510(k) is not detailed.
8. The Sample Size for the Training Set
- Information in document: Not present.
- Missing: ELISA kits do not typically have a "training set" in the same way machine learning algorithms do. However, during the development of the kit, a large number of characterized samples would be used to optimize the assay's cutoff values and ensure robust performance. The size of this internal optimization/development set is not mentioned.
9. How the Ground Truth for the Training Set Was Established
- Information in document: Not present.
- Missing: As explained above, the concept of a "training set" doesn't directly apply in the AI sense. For the samples used in the development and optimization of the ELISA, the ground truth would have been established through a similar combination of clinical diagnosis and confirmatory laboratory testing as described for the test set.
To obtain the specific details requested, you would need to access the 510(k) Summary (K113397) for this device, which the FDA generally makes publicly available. That document typically contains the detailed clinical and analytical study results used to support the substantial equivalence claim.
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).