510(k) · Cleared
ClearedEliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Nov 27, 2018 as substantially equivalent to K082759 (Phadia US, Inc., 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Nov 27, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922830 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK922830 Quanta Lite SS-a ElisaInova Diagnostics, Inc. · 1992
- 1 generation backK082759 Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay…Phadia US, Inc. · 2009
- This deviceK182353 EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922830 | Quanta Lite SS-a Elisa | Inova Diagnostics, Inc. | 1992 | — |
| −1 | K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO… | Phadia US, Inc. | 2009 | — |
| 0 (this device) | K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | Phadia AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 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 LJM? 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? (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 |
|---|---|---|---|
| * | K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO ImmunoassaySummary page 6…H2500/5000 K182353.510kSummary.FINAL.doc A.6-3 I. Device Description: The method-specific reagents are identical with K082759 (EliA CENP and EliA U1RNP) and K083117 (EliA RNP70), but are filled in containers specific for the Phadia 2500/5000 instr… | 2009 |
| * | K083117 | Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models…Summary page 6…A.6-3 I. Device Description: The method-specific reagents are identical with K082759 (EliA CENP and EliA U1RNP) and K083117 (EliA RNP70), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test We… | 2009 |
| † | K061165 | Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 | 2006 |
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 26 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All LJM devicesLJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LJM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LJM
265in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJM
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJM
No MAUDE report names LJM 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 | — | 2 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 3 | 265 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 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 CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in…
Read the full statement (176 words)
EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182353: EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182353
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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