# K220016: Viramed Borrela All-In-One ViraChip Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Viramed Biotech AG
- Decided: Aug 19, 2022 after 226 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K252627: Lyme-ID IgG Test; Bio-ID800 (2025), 0 descendants of its own
- K242872: iDart Lyme IgM ImmunoBlot Kit (2025), 0 descendants of its own
- K233367: iDart Lyme IgG ImmunoBlot Kit (2024), 0 descendants of its own

## Indications for use
The Viramed Biotech AG Borrelia All-In-One ViraChip is an in vitro qualitative microarray assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the Viramed Biotech AG Borrelia All-In-One ViraChip are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease. The Viramed Biotech AG Borrelia All-In-One ViraChip Test must be used with a ViraChip Reader and the ViraChip Software.

Source page: https://510kreport.com/device/K220016
Methodology: https://510kreport.com/methodology