510(k) · Cleared
ClearedMardx Lyme Disease (Igm) Marblot Strip Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mardx Diagnostics, Inc. · LSR Reagent, Borrelia Serological Reagent
Cleared on Jun 7, 1996 after a 421-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jun 7, 1996
- Review
- 421 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK951709 Mardx Lyme Disease (Igm) Marblot Strip Test SystemMardx Diagnostics, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK113846 Borrelia Burgdorferi Igm Blot TestGold Standard Diagnostics · 2012
- Descendant · 2 generations on · 0 of its ownK203292 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics · 2021
- Descendant · 2 generations on · 0 of its ownK203295 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics · 2021
- Descendant · cites it directly · 0 of its ownK172254 Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech · 2017
- Descendant · cites it directly · 0 of its ownK980351 Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitBoston Biomedica, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K113846Borrelia Burgdorferi Igm Blot TestGold Standard Diagnostics · 2012 · cites it directly2descendants
- K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics · 2021 · 2 generations on0descendants
- K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics · 2021 · 2 generations on0descendants
- K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech · 2017 · cites it directly0descendants
- K980351Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitBoston Biomedica, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951709 | Mardx Lyme Disease (Igm) Marblot Strip Test System | Mardx Diagnostics, Inc. | 1996 | — |
| +1 | K113846 | Borrelia Burgdorferi Igm Blot Test | Gold Standard Diagnostics | 2012 | — |
| +2 | K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021 | — |
| +2 | K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2021 | — |
| +1 | K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | Trinity Biotech | 2017 | — |
| +1 | K980351 | Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit | Boston Biomedica, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
3 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?
- Of its descendants, K113846 (Gold Standard Diagnostics, 2012) has gone furthest, with 2 descendants 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.
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?
MarDx Lyme Disease (IgM) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgM antibody to B. burgdorferi. The MarDx Lyme Disease (IgM) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure.
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/K951709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951709: Mardx Lyme Disease (Igm) Marblot Strip Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951709
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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