510(k) · Cleared
ClearedLIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LSR Reagent, Borrelia Serological Reagent
Cleared on Jan 29, 2020 as substantially equivalent to K113397 (Zeus Scientific, Inc., 2012) after an 89-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Jan 29, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K113397 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backK113397 Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test SystemZeus Scientific, Inc. · 2012
- This deviceK193051 LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus…DiaSorin, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K113397 | Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System | Zeus Scientific, Inc. | 2012 | — |
| 0 (this device) | K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | 2020 | — |
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 12.5 · 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? (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 |
|---|---|---|---|
| * | K113397 | Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test SystemSummary page 3…LSR Predicate Device: Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System (K113397) INTENDED USE: LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoas… | 2012 |
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.
What does this lineage say?
- Its one ancestor has no 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. 2020, 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?
LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of lgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma (K2-EDTA, Li-heparin) samples. This assay is intended for use on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing…
Read the full statement (186 words)
LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of lgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma (K2-EDTA, Li-heparin) samples. This assay is intended for use on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Lyme Total Antibody Plus assay should not be used to exclude Lyme disease. The test has to be performed on the LIAISON® XL Analyzer.
The LIAISON® Lyme Total Antibody Plus Control Set: The LIAISON® Lyme Total Antibody Plus Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Lyme Total Antibody Plus assay. The performance characteristics of LIAISON® Lyme Total Antibody Plus Control Set have not been established for any other assays or instrument platforms different from the LIAISON® XL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193051: LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193051
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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