# K994004: Quanta Lite Lyme B. Burgdorferi Igg/Igm Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jan 27, 2000 after 64 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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. burgdorfenri. 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. burgdorfen infection.

Source page: https://510kreport.com/device/K994004
Methodology: https://510kreport.com/methodology