510(k) · Cleared
ClearedEliA SmDP-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · LKP Anti-Sm Antibody, Antigen And Control
Cleared on Jul 14, 2021 as substantially equivalent to K132631 (Phadia US, Inc., 2014) after a 352-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Jul 14, 2021
- Review
- 352 days
- Class
- Class II
- Product code
- LKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132631 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK132631 Eia SMDP ImmunoassayPhadia US, Inc. · 2014 · Recalled
- This deviceK202067 EliA SmDP-SPhadia AB · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132631 | Eia SMDP Immunoassay | Phadia US, Inc. | 2014 | 1 |
| 0 (this device) | K202067 | EliA SmDP-S | Phadia AB | 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 LKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K132631 | Eia SMDP ImmunoassaySummary page 6…struments are automated platforms for EliA test procedures from sample and reagent handling to the processing of results. Substantial Equivalence EliA SmDP, Phadia AB, K132631 Comparison with Predicate Device: Similarities Pr… | 2014 |
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 a recall.
- 1 other device also cites its predicate K132631.
How does its category compare?
All LKP devicesLKP Anti-Sm Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LKP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LKP
Too few LKP 510(k)s in any year since 2007 to give a median.
Recalls per year · LKP
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKP
No MAUDE report names LKP 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 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?
EliA SmDP-S is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP-S uses the EliA IgG method.
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/K202067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202067: EliA SmDP-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202067
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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