510(k) · Cleared
ClearedBiramed Biotech Borrelia B31 Igm Virablot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viramed Biotech AG · LSR Reagent, Borrelia Serological Reagent
Cleared on Aug 11, 2005 after a 104-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 11, 2005
- Review
- 104 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LSR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LSR device
- #1 K254295 Sofia Lyme FIA; Sofia 2 Campylobacter FIAscore 12.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LSR
133in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSR
1in 2025
MAUDE reports naming product code LSR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 155 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 53 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 6 | 150 | 0 | 9 |
| 2018 | 3 | 92 | 0 | 4 |
| 2019 | 4 | 86 | 0 | 15 |
| 2020 | 3 | 91 | 0 | 7 |
| 2021 | 6 | 133 | 2 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Viramed Biotech Borrelia B31 1gM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing 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 of Lyme…
Read the full statement (134 words)
The Viramed Biotech Borrelia B31 1gM ViraBlot® is an in vitro qualitative assay
for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is
intended for use in testing 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 of Lyme disease.
The Viramed Biotech Borrelia B31 ViraBlot can be used during the acute
phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this
early period, infected patients are usually found to be Western blot positive for
IgG. A positive IgM test alone is not recommended for use in determining
active disease in persons with illness of longer than one month.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051169: Biramed Biotech Borrelia B31 Igm Virablot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026