# K971170: Cambridge Biotech Human Lyme Igm Western Blot (90112)

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Biotech Corp.
- Decided: Feb 17, 1998 after 326 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. The FDA summary names no predicate by number.

## Indications for use
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is an in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum. The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of infection with Borrelia burgdorferi. The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this 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/K971170
Methodology: https://510kreport.com/methodology