510(k) · Cleared
ClearedEliA Ro52, EliA Ro60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · LKJ Antinuclear Antibody, Antigen, Control
Cleared on Jul 27, 2022 as substantially equivalent to K141655 (Inova Diagnostics, Inc., 2015) and 1 other predicate after a 488-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 27, 2022
- Review
- 488 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962719 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962719 | Hycor HY.Tec/Manual SS-a Auto-Antibody | Hycor Biomedical, Inc. | 1997 | — |
| −1 | K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls | Inova Diagnostics, Inc. | 2015 | — |
| 0 (this device) | K210902 | EliA Ro52, EliA Ro60 | Phadia AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 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 LKJ? 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 |
|---|---|---|---|
| * | K141655 | Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsSummary page 9…ted platforms for EliA test procedures from sample and reagent handling to the processing of results. Substantial Equivalence QUANTA Flash Ro52, Inova Diagnostics Inc. (K141655) QUANTA Flash Ro60, Inova Diagnostics Inc. (K141328)… | 2015 |
| * | K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsSummary page 9…nd reagent handling to the processing of results. Substantial Equivalence QUANTA Flash Ro52, Inova Diagnostics Inc. (K141655) QUANTA Flash Ro60, Inova Diagnostics Inc. (K141328) Confidential Phadia AB, Rapsgatan 7P, P.O. Box 6… | 2015 |
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 25 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K141655.
How does its category compare?
All LKJ devicesLKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LKJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LKJ
Too few LKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKJ
2in 2018
MAUDE reports naming product code LKJ, 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 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 7 | 2 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EliA Ro52 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro52 in human serum as an aid in the diagnosis of Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM) in conjunction with other laboratory and clinical findings. EliA Ro52 uses the EliA IgG method.
EliA Ro60 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro60 in human serum as an aid in the diagnosis of Sjogren's syndrome (SS) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Ro60 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/K210902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210902: EliA Ro52, EliA Ro60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210902
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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