(66 days)
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/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 suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.
ZEUS ELISA Borrelia burgdorferi IgG Test System: The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches: (1) Standard two-tier test methodology (STTT) using IgG Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.
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The provided FDA 510(k) clearance letter and Indications for Use statement do not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a specific study proving device performance. This document primarily focuses on the regulatory clearance process and the intended use of the devices, rather than the raw performance data from clinical or analytical studies.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
- Details about standalone (algorithm-only) performance studies.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states one of the devices is "ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System." ELISA is an Enzyme-Linked Immunosorbent Assay, which is a laboratory assay for detecting antibodies, not an AI or digital imaging device. Therefore, questions related to "human readers improving with AI" or "standalone algorithm performance" are not applicable to these specific devices as described.
The document indicates the following regarding ground truth:
- Type of Ground Truth: The device is intended to detect IgG and IgM class antibodies. Positive and equivocal results "must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays..." This implies that the 'ground truth' or confirmatory standard is based on established laboratory diagnostic protocols (Western blot or other ELISA assays), rather than expert consensus on images, pathology, or direct outcome data in the context of an AI device.
To obtain the specific performance data, acceptance criteria, and study details you're looking for, you would typically need to consult the full 510(k) submission, clinical study reports, or peer-reviewed publications related to these specific devices, which are not included in the provided text. The FDA clearance letter summarizes the regulatory decision and the intended use, but not the detailed underlying performance data.
§ 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).