510(k) · Cleared
ClearedSofia Lyme FIA, Sofia Lyme Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · LSR Reagent, Borrelia Serological Reagent
Cleared on Oct 20, 2017 as substantially equivalent to K122979 (Biomerieux S.A., 2013) and 1 other predicate after a 294-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Oct 20, 2017
- Review
- 294 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894224 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK894224 Mardx Lyme Disease Eia (Igg) Test SystemMardx Diagnostics, Inc. · 1989
- 2 generations backK080012 Platelia Lyme Igg AssayBio-Rad · 2008
- 1 generation backK122986 Vidas Lyme IggBiomerieux S.A. · 2013
- This deviceK163713 Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894224 | Mardx Lyme Disease Eia (Igg) Test System | Mardx Diagnostics, Inc. | 1989 | — |
| −2 | K080012 | Platelia Lyme Igg Assay | Bio-Rad | 2008 | — |
| −1 | K122986 | Vidas Lyme Igg | Biomerieux S.A. | 2013 | — |
| 0 (this device) | K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K122979 | Vidas Lyme IgmSummary page 6…FIA test system. 5.10. Substantial Equivalence Information: 1. Predicate Device Name: Vidas Lyme IgM and Vidas Lyme IgG 2. Predicate 510(k) Numbers: K122979 and K122986 Sofia® Lyme FIA and Control Set 510(k) VOLUME 1 Page 5-3… | 2013 |
| * | K122986 | Vidas Lyme IggSummary page 6…tem. 5.10. Substantial Equivalence Information: 1. Predicate Device Name: Vidas Lyme IgM and Vidas Lyme IgG 2. Predicate 510(k) Numbers: K122979 and K122986 Sofia® Lyme FIA and Control Set 510(k) VOLUME 1 Page 5-3… | 2013 |
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 28 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K122979.
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. This qualitative test is intended for use as an aid in the diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. All positive results for IgM and/or IgG should be further tested by a…
Read the full statement (121 words)
The Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. This qualitative test is intended for use as an aid in the diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. All positive results for IgM and/or IgG should be further tested by a corresponding second-tier western blot assay. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures.
The Sofia Lyme Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Lyme FIA test system.
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/K163713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163713: Sofia Lyme FIA, Sofia Lyme Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163713
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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