# K971006: Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)

- Pathway: 510(k) (Traditional)
- Applicant: Mrl Diagnostics
- Decided: Jun 1, 1998 after 439 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 K883487 (1988). 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)
- K883487: Lyme Disease Ifa (Igg), Hillcrest Biologicals (1988) Summary page 1.

## Indications for use
MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup | (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis of Lyme disease, using serum samples which have been found positive or equivocal by a B. burgdorferi screening method (e.g., IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG can be used at any time following onset of symptoms provided the IFA or ELISA is positive or equivocal. Also, it should be used for follow up when: 1) only IgM antibodies were originally detected, 2) IgG antibodies were detected, but were not considered significant by Western blot, or 3) previously seronegative patients subsequently test positive by IFA or ELISA.

Source page: https://510kreport.com/device/K971006
Methodology: https://510kreport.com/methodology