510(k) · Cleared
ClearedViramed Biotech AG Borrelia B31 Igm Virastripe
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 5, 2009 after a 356-day review. The FDA summary names no predicate by number.
- Decided
- Aug 5, 2009
- Review
- 356 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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 12.6 · 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?
The FDA summary names no predicate by number.
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. 2009, this device’s year, is highlighted.
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 AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against 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 line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent…
Read the full statement (146 words)
The Viramed Biotech AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against 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 line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 IgM ViraStripe ® can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorfen infection. Patients who are positive by IgM but not IgG should have the test repeated a few weeks later if they remain ill. If they are still positive only by IgM and have been ill longer than one month, this is likely a false positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082329: Viramed Biotech AG Borrelia B31 Igm Virastripe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082329
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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