# K980351: Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Mar 5, 1999 after 400 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
Longest line of descent: 1 generation back to K951709 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951709: Mardx Lyme Disease (Igm) Marblot Strip Test System, Mardx Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The BBI-Biotech B. burgdorferi IgM Western blot Kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

Source page: https://510kreport.com/device/K980351
Methodology: https://510kreport.com/methodology