510(k) · Cleared
ClearedLIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
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 Feb 18, 2021 as substantially equivalent to K900196 (Zeus Scientific, Inc., 1990) and 1 other predicate after a 167-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 18, 2021
- Review
- 167 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900196 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900196 Lyme Igm Elisa Test SystemZeus Scientific, Inc. · 1990
- This deviceK202573 LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total…DiaSorin, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900196 | Lyme Igm Elisa Test System | Zeus Scientific, Inc. | 1990 | — |
| 0 (this device) | K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 12.5 · 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? (2)
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 |
|---|---|---|---|
| * | K900196 | Lyme Igm Elisa Test SystemSummary page 4…LSR and QCH Predicate Device: ZEUS ELISA Borrelia burgdorferi IgM Test System (K900196)/modified (K191240) INTENDED USE: The LIAISON® Lyme IgM assay uses chemiluminescent immunoassay (CLIA) technology for the qualita… | 1990 |
| * | K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…Summary page 4…ate Device: ZEUS ELISA Borrelia burgdorferi IgM Test System (K900196)/modified (K191240) INTENDED USE: The LIAISON® Lyme IgM assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of I… | 2019 |
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?
- None of the 2 ancestors has a 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. 2021, 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 LIAISON® Lyme IgM assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgM antibodies to Borrelia burgdorferi in human serum and plasma samples (K2-EDTA, Li-heparin). This assay is intended for use on samples from patients with signs and symptoms consistent with or patients suspected of having Lyme disease to assess the presence of antibodies and exposure to Borrelia burgdorferi. In addition, the LIAISON® Lyme…
Read the full statement (247 words)
The LIAISON® Lyme IgM assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgM antibodies to Borrelia burgdorferi in human serum and plasma samples (K2-EDTA, Li-heparin). This assay is intended for use on samples from patients with signs and symptoms consistent with or patients suspected of having Lyme disease to assess the presence of antibodies and exposure to Borrelia burgdorferi. In addition, the LIAISON® Lyme IgM assay may be used as a confirmatory test in the modified two-tier test (MTTT) in combination with the DiaSorin LIAISON® Lyme Total Antibody Plus assay.
If used as a first stage test, positive or equivocal results with the LIAISON® Lyme IgM assay should be confirmed through additional testing with a Standard two-tier test (STTT) methodology using an IgM Borrelia burgdorferi Western blot test following current guidelines.
Positive supplemental results are supportive evidence of the presence of antibodies and exposure to Borrelia burgdorferi and may be used along with patient history, symptoms and other laboratory data to support a clinical diagnosis of Lyme disease.
Negative results by the LIAISON® Lyme IgM assay should not be used to exclude Lyme disease.
The test must be performed on the LIAISON® XL Analyzer.
The DiaSorin LIAISON® Lyme IgM Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Lyme IgM assay. The performance characteristics of LIAISON® Lyme IgM controls 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/K202573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202573: LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202573
Report an extraction error
Are you the manufacturer?
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