510(k) · Cleared
ClearedGold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Diagnostics · LSR Reagent, Borrelia Serological Reagent
Cleared on Mar 22, 2021 as substantially equivalent to K894224 (Mardx Diagnostics, Inc., 1989) and 1 other predicate after a 133-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 22, 2021
- Review
- 133 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950829 (1996). 3 ancestors in all, the oldest K894224 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK950829 Mardx Lyme Disease (Igg) Marblot Strip Test SystemMardx Diagnostics, Inc. · 1996
- 1 generation backK113847 Borrelia Burgdorferi Igg Blot TestGold Standard Diagnostics · 2012
- This deviceK203296 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950829 | Mardx Lyme Disease (Igg) Marblot Strip Test System | Mardx Diagnostics, Inc. | 1996 | — |
| −1 | K113847 | Borrelia Burgdorferi Igg Blot Test | Gold Standard Diagnostics | 2012 | — |
| 0 (this device) | K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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? (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 |
|---|---|---|---|
| * | K894224 | Mardx Lyme Disease Eia (Igg) Test SystemSummary page 4…nd data remain the same. 3) Legally Marketed Device to Which the Submitter Claims Equivalence: a. STTT - Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit (K894224). b. MTTT - Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test Kit (K113847) 4) Description of the Device: The k… | 1989 |
| * | K113847 | Borrelia Burgdorferi Igg Blot TestSummary page 4…lence: a. STTT - Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit (K894224). b. MTTT - Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test Kit (K113847) 4) Description of the Device: The kit includes 12 x 8 well Antigen Coated strips, Conjugate, Substrate, Stop Solution, Wash… | 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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 15.8 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K894224.
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 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods: » Standard two-tier test methodology (STTT) using an…
Read the full statement (177 words)
The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods:
» Standard two-tier test methodology (STTT) using an IgG blot test following current interpretation guidelines, OR
» Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
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/K203296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203296: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203296
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