510(k) · Cleared
ClearedPlatelia Lyme Igg Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LSR Reagent, Borrelia Serological Reagent
Cleared on May 8, 2008 as substantially equivalent to K894224 (Mardx Diagnostics, Inc., 1989) after a 126-day review. Its family tree reaches back 1 generation to 1989. 5 later devices descend from it.
- Decided
- May 8, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894224 (1989). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894224 Mardx Lyme Disease Eia (Igg) Test SystemMardx Diagnostics, Inc. · 1989
- This deviceK080012 Platelia Lyme Igg AssayBio-Rad · 2008
- Descendant · cites it directly · 4 of its ownK122986 Vidas Lyme IggBiomerieux S.A. · 2013
- Descendant · 2 generations on · 1 of its ownK173691 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK254295 Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026
- Descendant · 2 generations on · 0 of its ownK163713 Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K122986Vidas Lyme IggBiomerieux S.A. · 2013 · cites it directly4descendants
- K173691Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation · 2018 · 2 generations on1descendant
- K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026 · 3 generations on0descendants
- K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation · 2017 · 2 generations on0descendants
- K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894224 | Mardx Lyme Disease Eia (Igg) Test System | Mardx Diagnostics, Inc. | 1989 | — |
| 0 (this device) | K080012 | Platelia Lyme Igg Assay | Bio-Rad | 2008 | — |
| +1 | K122986 | Vidas Lyme Igg | Biomerieux S.A. | 2013 | — |
| +2 | K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Quidel Corporation | 2018 | — |
| +3 | K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026 | — |
| +2 | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2017 | — |
| +2 | K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M… | Biomerieux | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K894224 | Mardx Lyme Disease Eia (Igg) Test SystemSummary page 1…ay Manufacturer: Mardx Diagnostics, Inc. Product: Mardx Lyme Disease EIA (IgG) Test - K894224 Product Attribute Product Platelia Bo-Rad TM Attribute Lyme… | 1989 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122986 | Vidas Lyme Igg | 2013 | 4 |
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?
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Platelia Lyme IgG assay is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma (K 3 EDTA, sodium heparin or sodium citrate). The EIA test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be re-tested with a specific, second-tier test such as Western…
Read the full statement (133 words)
The Platelia Lyme IgG assay is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma (K 3 EDTA, sodium heparin or sodium citrate). The EIA test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be re-tested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080012: Platelia Lyme Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080012
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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