# K092693: Viramed Biotech AG Borrelia B31 Igg Virastripe, Model V-Bbsgus

- Pathway: 510(k) (Traditional)
- Applicant: Viramed Biotech AG
- Decided: Nov 25, 2009 after 84 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. The FDA summary names no predicate by number.

## Indications for use
The Viramed Biotech AG Borrelia B31 IgG ViraStripe® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdotferi 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 line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 IgG ViraStripe® can be used anytime after onset of symptoms 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 an line blot assay or Western blot, 2) IgG antibodies were found by line blot or Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested sero-negative individuals are shown to develop antibodies by an EIA or IFA test. The Viramed Biotech AG Borrelia B31 ViraStripe has not been studied in pediatric or adolescent patients.

Source page: https://510kreport.com/device/K092693
Methodology: https://510kreport.com/methodology