510(k) · Cleared
ClearedEliA CTD 13 Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Jun 25, 2026 as substantially equivalent to K190710 (Phadia AB, 2019) and 3 other predicates after a 268-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jun 25, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K880736 (1988). 10 ancestors in all, the oldest K874873 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK880736 Nova Lite (TM) AnaInova Diagnostics, Inc. · 1988
- 2 generations backK072149 Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01Phadia US, Inc. · 2008
- 1 generation backK190710 EliA SymphonyS ImmunoassayPhadia AB · 2019
- This deviceK253367 EliA CTD 13 ScreenPhadia AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880736 | Nova Lite (TM) Ana | Inova Diagnostics, Inc. | 1988 | — |
| −2 | K072149 | Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01 | Phadia US, Inc. | 2008 | — |
| −1 | K190710 | EliA SymphonyS Immunoassay | Phadia AB | 2019 | — |
| 0 (this device) | K253367 | EliA CTD 13 Screen | Phadia AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 2 | 0 |
| 2021 | 2 | 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 LLL? 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 LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K190710 | EliA SymphonyS ImmunoassaySummary page 7…st procedures from sample and reagent handling to the processing of results. Substantial Equivalence Predicate devices: EliA SymphonyS Immunoassay, Phadia AB, Sweden (K190710) EliA dsDNA Immunoassay, Phadia AB, Sweden (K072393) EliA Rib-P, Phadia AB, Sweden (K202540) EliA RNA Pol III, Phadia AB, Sweden… | 2019 |
| * | K072393 | Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01Summary page 7…e processing of results. Substantial Equivalence Predicate devices: EliA SymphonyS Immunoassay, Phadia AB, Sweden (K190710) EliA dsDNA Immunoassay, Phadia AB, Sweden (K072393) EliA Rib-P, Phadia AB, Sweden (K202540) EliA RNA Pol III, Phadia AB, Sweden (K202541) Phadia AB, Rapsgatan 7P, P.O. Box 6460… | 2007 |
| * | K202540 | EliA Rib-PSummary page 7…quivalence Predicate devices: EliA SymphonyS Immunoassay, Phadia AB, Sweden (K190710) EliA dsDNA Immunoassay, Phadia AB, Sweden (K072393) EliA Rib-P, Phadia AB, Sweden (K202540) EliA RNA Pol III, Phadia AB, Sweden (K202541) Phadia AB, Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden… | 2021 |
| * | K202541 | EliA RNA Pol IIISummary page 7…Immunoassay, Phadia AB, Sweden (K190710) EliA dsDNA Immunoassay, Phadia AB, Sweden (K072393) EliA Rib-P, Phadia AB, Sweden (K202540) EliA RNA Pol III, Phadia AB, Sweden (K202541) Phadia AB, Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden Page 3 (19) 510(k) Decision S… | 2021 |
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 38 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
EliA CTD 13 Screen is intended for the in vitro qualitative detection of antinuclear IgG antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE), Sjögren's syndrome (SS), systemic sclerosis (SSc), polymyositis (PM), dermatomyositis (DM) and mixed connective tissue disease (MCTD), in conjunction with other laboratory and clinical findings. EliA CTD 13 Screen detects antibodies against RNP70, U1RNP-A, U1RNP-C, SS-A/Ro60, SS-A/Ro52, SS-B/La, Centromere B, Scl-70, Jo-1, RNA Pol III, Rib-P, Sm and dsDNA. EliA CTD 13 Screen uses the EliA IgG method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253367: EliA CTD 13 Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253367
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026