510(k) · Cleared
ClearedSofia 2 Campylobacter FIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · LQP Campylobacter Spp.
Cleared on Nov 23, 2021 as substantially equivalent to K191456 (Techlab, Inc., 2019) after a 204-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Nov 23, 2021
- Review
- 204 days
- Class
- Class I
- Product code
- LQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K191456 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK191456 Campylobacter Quik ChekTechlab, Inc. · 2019
- This deviceK211342 Sofia 2 Campylobacter FIAQuidel Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K191456 | Campylobacter Quik Chek | Techlab, Inc. | 2019 | — |
| 0 (this device) | K211342 | Sofia 2 Campylobacter FIA | Quidel Corporation | 2021 | — |
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 LQP? 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 LQP device
- #1 K210976 Curian Campyscore 2.6 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K191456 | Campylobacter Quik ChekSummary page 4…Description LQP 1 21 CFR 866.3110 Campylobacter spp. Panel Microbiology Predicate Device CAMPYLOBACTER QUIK CHEK™ (K191456) Device Description The Sofia 2 Campylobacter FIA employs immunofluorescence technology that is used with Sofia 2 for the rapid… | 2019 |
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.
- 1 other device also cites its predicate K191456.
How does its category compare?
All LQP devicesLQP Campylobacter Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LQP
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LQP
Too few LQP 510(k)s in any year since 2007 to give a median.
Recalls per year · LQP
No recall names LQP since 2007.
Adverse event reports per year · LQP
No MAUDE report names LQP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Sofia 2 Campylobacter FIA employs immunofluorescence for the rapid qualitative detection of a Campylobacter-specific antigen in
human fecal specimens. Sofia 2 Campylobacter FIA is designed to detect C. jejuni, C. coli, C. lari and C. upsaliensis from patients
with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and
unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211342: Sofia 2 Campylobacter FIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211342
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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