# K971169: Cambridge Biotech Human Lyme Igg Western Blot (90111)

- 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 IgG 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 assay is not intended for use as a screening assay, nor should it be used for analysis of serum from patients who have not demonstrated symptoms of Lyme Disease.

Source page: https://510kreport.com/device/K971169
Methodology: https://510kreport.com/methodology