510(k) · Cleared
ClearedElia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Jan 15, 2008 as substantially equivalent to K961913 (Inova Diagnostics, Inc., 1996) and 1 other predicate after a 165-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Jan 15, 2008
- Review
- 165 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880736 (1988). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK880736 Nova Lite (TM) AnaInova Diagnostics, Inc. · 1988
- This deviceK072149 Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01Phadia US, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK190710 EliA SymphonyS ImmunoassayPhadia AB · 2019
- Descendant · 2 generations on · 0 of its ownK253367 EliA CTD 13 ScreenPhadia AB · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880736 | Nova Lite (TM) Ana | Inova Diagnostics, Inc. | 1988 | — |
| 0 (this device) | 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 | — |
| +2 | K253367 | EliA CTD 13 Screen | Phadia AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2026 | 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 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
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K961913 | Quanta Lite Ena 6 ElisaSummary page 1…LLL 11 866.5100 Substantial Equivalence to QUANTA Lite'Tm ENA 6 5 10(k) number: K961913 (predicate device for RNP Antibodies, SS-A/Ro Antibodies, SS-B/La Antibodies, Scl-70 Antibodies, Jo-i Antibo… | 1996 |
| * | K880736 | Nova Lite (TM) AnaSummary page 1…ies, SS-B/La Antibodies, Scl-70 Antibodies, Jo-i Antibodies and Sm Antibodies) NOVA Lite Tm HEp-2 5 10(k) number: K(880736 (predicate device for CENP Antibodies) CONFIDENTIAL AND PROPRIETARY-Page… | 1988 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190710 | EliA SymphonyS Immunoassay | 2019 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K190710 (Phadia AB, 2019) has gone furthest, with 1 descendant of its own.
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. 2008, 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?
EllA Symphony Immunoassay is intended for the in vitro, qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant UIRNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SS-B/La, Centromere B, Scl-70, Jo-I proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus…
Read the full statement (137 words)
EllA Symphony Immunoassay is intended for the in vitro, qualitative measurement of antinuclear IgG antibodies in human serum and plasma (heparin, EDTA and citrate). EliA Symphony Immunoassay is based on human recombinant UIRNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SS-B/La, Centromere B, Scl-70, Jo-I proteins and native purified Sm proteins as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sj6gren's syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings. EllA Symphony Immunoassay uses the EllA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072149: Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072149
Report an extraction error
Are you the manufacturer?
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