510(k) · Cleared
ClearedVidas Lyme Igm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux S.A. · LSR Reagent, Borrelia Serological Reagent
Cleared on Jun 4, 2013 as substantially equivalent to K081362 (Bio-Rad, 2008) after a 251-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.
- Decided
- Jun 4, 2013
- Review
- 251 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894293 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK894293 Mardx Lyme Disease Eia (Igm) Test SystemMardx Diagnostics, Inc. · 1989
- 1 generation backK081362 Platelia Lyme IgmBio-Rad · 2008
- This deviceK122979 Vidas Lyme IgmBiomerieux S.A. · 2013
- Descendant · cites it directly · 1 of its ownK173691 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK254295 Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026
- Descendant · cites it directly · 0 of its ownK163713 Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K173691Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation · 2018 · cites it directly1descendant
- K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026 · 2 generations on0descendants
- K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894293 | Mardx Lyme Disease Eia (Igm) Test System | Mardx Diagnostics, Inc. | 1989 | — |
| −1 | K081362 | Platelia Lyme Igm | Bio-Rad | 2008 | — |
| 0 (this device) | K122979 | Vidas Lyme Igm | Biomerieux S.A. | 2013 | — |
| +1 | K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Quidel Corporation | 2018 | — |
| +2 | K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026 | — |
| +1 | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081362 | Platelia Lyme IgmSummary page 2…mmary A general comparison of the similarities and differences of the assays is presented in the table below. ’ tem = | VIDAS® Lyme I'gM(LYM) Assay Platelia™ Lyme IgM (K081362) The VIDAS Lyme IgM (LYM) assay | The Platelia™ Lyme IgM Test is a is an automated qualitative enzyme |qualitative test intended… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173691 (Quidel Corporation, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgM-positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122979: Vidas Lyme Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122979
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026