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K Number
K191240
Device Name
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
Manufacturer
ZEUS Scientific Inc.
Date Cleared
2019-07-29

(82 days)

Product Code
LSR
Regulation Number
866.3830
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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 approaches:

(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 B. burgdorferi antibodies, history, symptoms, and other laboratory data.

ZEUS ELISA Borrelia burgdorferi IgM Test System

The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibodies 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 IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:

(3) Standard two-tier test methodology (STTT) using IgM Western blot testing following current interpretation guidelines; or

(4) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/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.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter does not contain the specific information required to complete your request. The document is primarily a formal notification of substantial equivalence for a medical device (ELISA test systems for Lyme disease) and outlines its intended use and regulatory details.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about the sample size used for a test set, data provenance, or information about training sets.
  • Mention of experts establishing ground truth, adjudication methods, or multi-reader multi-case (MRMC) studies.
  • Information on standalone algorithm performance or the type of ground truth used in validation studies.

To get this information, you would typically need to refer to the actual 510(k) submission document or the device's Instructions For Use (IFU), which would contain the detailed studies and performance data submitted to the FDA for clearance. The provided text is merely the FDA's decision letter based on that submission.

§ 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).