510(k) · Cleared
ClearedPrevue (TM) Borrelia Burgdorferi Antibody Detection Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chembio Diagnostic Systems, Inc. · LSR Reagent, Borrelia Serological Reagent
Cleared on Feb 12, 1999 as substantially equivalent to K965131 (Wampole Laboratories, 1997) after a 256-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 12, 1999
- Review
- 256 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965131 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK965131 Borrelia Burgdorferi Igg/Igm Elisa Test SystemWampole Laboratories · 1997
- This deviceK981913 Prevue (TM) Borrelia Burgdorferi Antibody Detection AssayChembio Diagnostic Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test System | Wampole Laboratories | 1997 | — |
| 0 (this device) | K981913 | Prevue (TM) Borrelia Burgdorferi Antibody Detection Assay | Chembio Diagnostic Systems, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemSummary page 1…n Name: Reagent, Borrelia Serological Reagent [21 CFR §866.3830] 83 LSR Predicate Device: The Wampole Borrelia burgdorferi 1gG/IgM ELISA 510(k) Document Control Number: K965131 Description of Device: The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a Class II in vitro medical diagnos… | 1997 |
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.
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 Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians’ office laboratories.
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/K981913 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981913: Prevue (TM) Borrelia Burgdorferi Antibody Detection Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981913
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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