510(k) Report

510(k) · Cleared

Cleared

Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay

K082759510(k) TraditionalCleared Apr 10, 2009200-day reviewClass II21 CFR 866.5100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Phadia US, Inc. · LKJ Antinuclear Antibody, Antigen, Control

Cleared on Apr 10, 2009 as substantially equivalent to K944171 (Elias U.S.A., Inc., 1994) and 4 other predicates after a 200-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided
Apr 10, 2009
Review
200 days
Class
Class II
Product code
LKJ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K922830 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1994: 2 other ancestors2018: 1 descendant clearedK922830 · Quanta Lite SS-a Elisa · Inova Diagnostics, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K922830 · Quanta Lite SS-a Elisa · Inova Diagnostics, Inc. · 19920
  1. Root · 1 generation backK922830 Quanta Lite SS-a ElisaInova Diagnostics, Inc. · 1992
  2. This deviceK082759 Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay…Phadia US, Inc. · 2009
  3. Descendant · cites it directly · 0 of its ownK182353 EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922830Quanta Lite SS-a ElisaInova Diagnostics, Inc.1992—
0 (this device)K082759Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO…Phadia US, Inc.2009—
+1K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K082759, 1992–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Top candidate predicates for a new LKJ device

  1. #1 K210902 EliA Ro52, EliA Ro60score 4.0 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K944171Varelisa Centromere Antibodies
Summary page 2
…== EliA T M ANA - New Devices Bundling 510(k) Submission Summary of Safety and Effectiveness Substantial Equivalence to Varelisa CENP Antibodies K944171 Varelisa U IRNP Antibodies K993589 Varelisa Sm Antibodies K0003 12 Quanta Lite SS-A ELI…
Elias U.S.A., Inc.1994—
*K993589Varelisa RNP Antibodies
Summary page 2
…ssion Summary of Safety and Effectiveness Substantial Equivalence to Varelisa CENP Antibodies K944171 Varelisa U IRNP Antibodies K993589 Varelisa Sm Antibodies K0003 12 Quanta Lite SS-A ELISA K922830 Varelisa SS-B/La Ant…
Pharmacia & Upjohn Co.1999—
*K000312Varelisa SM Antibodies
Summary page 2
…bstantial Equivalence to Varelisa CENP Antibodies K944171 Varelisa U IRNP Antibodies K993589 Varelisa Sm Antibodies K0003 12 Quanta Lite SS-A ELISA K922830 Varelisa SS-B/La Antibodies K944168…
Pharmacia & Upjohn Co.2000—
*K922830Quanta Lite SS-a Elisa
Summary page 2
…ies K944171 Varelisa U IRNP Antibodies K993589 Varelisa Sm Antibodies K0003 12 Quanta Lite SS-A ELISA K922830 Varelisa SS-B/La Antibodies K944168 Intended Use Statements of the New Devices…
Inova Diagnostics, Inc.1992—
*K944168Varelisa LA (SS-B) Antibodies
Summary page 2
…odies K993589 Varelisa Sm Antibodies K0003 12 Quanta Lite SS-A ELISA K922830 Varelisa SS-B/La Antibodies K944168 Intended Use Statements of the New Devices I) EliATM CENP is intended for the in vitro semi…
Elias U.S.A., Inc.1994—

Also cleared against K944171: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB20180

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 5 ancestors has a recall.
  • Of its descendants, K182353 (Phadia AB, 2018) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K944171.

How does its category compare?

All LKJ devices

LKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LKJ

1in 2022

2008: 12009: 12012: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 12010: 72015: 12017: 12019: 1
2007high 7 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LKJ

2in 2018

2010: 22011: 172017: 22018: 2
2007high 17 (2011) · low 0 (2007)2025

MAUDE reports naming product code LKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—10
20081—00
20091—00
20100—72
20110—017
20121—00
20130—00
20140—00
20150—10
20160—00
20170—12
20180—02
20190—10
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EIiATM Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM La is intended for the in vitro semi-quantitative measurement of IgG…

Read the full statement (308 words)

EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EIiATM Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjogren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA TM La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

EliATM Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjdgren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliATM Ro uses the EHiA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

EliATM UI RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) 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. EliATM U1RNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

EliATM CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliATM CENP uses the EIiA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

Indications for use as stated in the FDA summary.

Also cleared against K944171

1 other device cites the same predicate.

  • K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006

More from Phadia US, Inc.

22 FDA decisions under this applicant name. See the company

  • K141375Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc. · 2015
  • K140225Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM Positive Control 100, Elia…Phadia US, Inc. · 20141 recall
  • K132631Eia SMDP ImmunoassayPhadia US, Inc. · 20141 recall
  • K131821Elia (TM) Cardiolipin Iga ImmunoassayPhadia US, Inc. · 2013
  • K122197Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige AntibodiesPhadia US, Inc. · 20131 recall

Recent decisions in LKJ

The LKJ category page

  • K210902EliA Ro52, EliA Ro60Phadia AB · 2022
  • K113610Ana-Screen with MDSSBio-Rad Laboratories · 20121 recall
  • K081104Aeskulisa Ana Hep-2, Ref 30-7115USAesku Diagnostics · 2008
  • K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200Bio-Rad Laboratories, Inc. · 20041 recall
  • K042416Athena Multi-Lyte Ana-II Test SystemZeus Scientific, Inc. · 2004

https://510kreport.com/device/K082759 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082759: Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082759

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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