# K163095: Lyme B. burgdorferi (IgG) MarStripe Test

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech
- Decided: Feb 1, 2017 after 89 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 4.

## Indications for use
Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgG antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (Ka-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

Source page: https://510kreport.com/device/K163095
Methodology: https://510kreport.com/methodology