# K163695: Borrelia B31 ViraChip IgM Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Viramed Biotech AG
- Decided: Aug 22, 2017 after 237 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test Kit is an in vitro qualitative protein microarray assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.

Source page: https://510kreport.com/device/K163695
Methodology: https://510kreport.com/methodology