# K984234: Quanta Lite Lyme Igm Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 15, 1999 after 141 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 IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of 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. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Westem 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. The QUANTA Lite™ Lyme B. burgdorferi IgM ELISA can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected individuals usually develop anti-B. burgdorferi 1gG antibodies and a positive IgM result alone is not recommended for supporting a diagnosis of active Lyme disease in persons with illness of greater than 1 month duration. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.

Source page: https://510kreport.com/device/K984234
Methodology: https://510kreport.com/methodology