# K032713: Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Nov 24, 2003 after 83 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 K950829 (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)
- K950829: Mardx Lyme Disease (Igg) Marblot Strip Test System, Mardx Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples that have been found positive or equivocal using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for B. burgdorferi antibodies.

Source page: https://510kreport.com/device/K032713
Methodology: https://510kreport.com/methodology