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K Number
K994004
Device Name
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2000-01-27

(64 days)

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

The QUANTA Lite™ Lyme B. burgdorferi IgG/IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgG and IgM antibodies to B. burgdorferi, the agent of Lyme disease (Lyme borreliosis), in human serum. This ELISA is intended to provide presumptive evidence of the presence of antibodies to B. burgdorferi. It should only be used for individuals with signs and symptoms consistent with Lyme disease. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays. Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.

Device Description

The QUANTA Lite™ Lyme B. burgdorferi IgG/IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA).

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific criteria. The document is an FDA 510(k) clearance letter for the "QUANTA Lite™ Lyme B. burgdorferi IgG/IgM ELISA" kit, indicating that the device has been found substantially equivalent to a legally marketed predicate device for the stated indications for use.

While it mentions the device's purpose (initial qualitative detection of IgG and IgM antibodies to B. burgdorferi in human serum for individuals with signs and symptoms consistent with Lyme disease), it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any studies.
  • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

§ 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).