# K970768: Human Lyme Igm Western Blot Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Diagnostics Ireland, Ltd.
- Decided: Apr 9, 1998 after 402 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 Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgM kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease. The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi IgM Western Blot kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

Source page: https://510kreport.com/device/K970768
Methodology: https://510kreport.com/methodology