# K051071: Viramed Biotech Borrelia B31 Igg Virablot

- Pathway: 510(k) (Traditional)
- Applicant: Viramed Biotech AG
- Decided: Aug 11, 2005 after 107 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 Borrelia B31 IgG ViraBlot® is an in vitro qualitative assay for the detection of IgG 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 Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

Source page: https://510kreport.com/device/K051071
Methodology: https://510kreport.com/methodology