510(k) Report

510(k) · Cleared

Cleared

Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01

K083117510(k) TraditionalCleared May 28, 2009218-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. · LKO Anti-Rnp Antibody, Antigen And Control

Cleared on May 28, 2009 as substantially equivalent to K993589 (Pharmacia & Upjohn Co., 1999) and 2 other predicates after a 218-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided
May 28, 2009
Review
218 days
Class
Class II
Product code
LKO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K944172 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1994: 1 other ancestor2018: 1 descendant clearedK944172 · Varelisa SCL-70 Antibodies · Elias U.S.A., Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K944172 · Varelisa SCL-70 Antibodies · Elias U.S.A., Inc. · 19940
  1. Root · 1 generation backK944172 Varelisa SCL-70 AntibodiesElias U.S.A., Inc. · 1994
  2. This deviceK083117 Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1…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
−1K944172Varelisa SCL-70 AntibodiesElias U.S.A., Inc.1994—
0 (this device)K083117Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay…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
199410
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K083117, 1994–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 LKO? 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
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What was it cleared against? (3)

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
*K993589Varelisa RNP Antibodies
Summary page 1
…II 866.5100 EhiA TM Jo-I LJM 1I 866.5100 Substantial Equivalence to Varelisa U1IRNP Antibodies K993589 Varelisa Scl-70 Antibodies K944 172 Varelisa Jo- I Antibodies K9441 73…
Pharmacia & Upjohn Co.1999—
*K944172Varelisa SCL-70 Antibodies
Summary page 1
…LJM 1I 866.5100 Substantial Equivalence to Varelisa U1IRNP Antibodies K993589 Varelisa Scl-70 Antibodies K944 172 Varelisa Jo- I Antibodies K9441 73 Intended Use Statements of the New Devices I…
Elias U.S.A., Inc.1994—
*K944173Varelisa JO-1 Antibodies
Summary page 1
…866.5100 Substantial Equivalence to Varelisa U1IRNP Antibodies K993589 Varelisa Scl-70 Antibodies K944 172 Varelisa Jo- I Antibodies K9441 73 Intended Use Statements of the New Devices I) EiAlTM RNP70 is intended for the in vitro se…
Elias U.S.A., Inc.1994—

Also cleared against K993589: 3 other devices →

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 3 ancestors has a recall.
  • Of its descendants, K182353 (Phadia AB, 2018) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K993589.

How does its category compare?

All LKO devices

LKO Anti-Rnp Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LKO

1in 2019

2007: 12009: 12013: 12014: 12019: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKO

Too few LKO 510(k)s in any year since 2007 to give a median.

Recalls per year · LKO

No recall names LKO since 2007.

Adverse event reports per year · LKO

No MAUDE report names LKO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20100—00
20110—00
20120—00
20131—00
20141—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

EliATM Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-I in human serum and plasma (heparin, EDTA, citrate) as. an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratoiy and clinical findings. EliATM Jo-1uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250. EliATM RNP70 is intended for the in vitro semi-quantitative measurement of IgG…

Read the full statement (178 words)

EliATM Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-I in human serum and plasma (heparin, EDTA, citrate) as. an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratoiy and clinical findings. EliATM Jo-1uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

EliATM RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (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. EliATM RNP70 uses the EIiA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

EiATM Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed toScl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliATM Scl-70 uses the EiA lgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

Indications for use as stated in the FDA summary.

Also cleared against K993589

3 other devices cite the same predicate.

  • K082759Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO ImmunoassayPhadia US, Inc. · 2009
  • K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
  • K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200Bio-Rad Laboratories, Inc. · 20041 recall

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 LKO

The LKO category page

  • K191085Maverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc. · 2019
  • K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014
  • K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US · 2013
  • K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
  • K022017Rhigene Mesacup-2 Test RNP, Model M7741Rhigene, Inc. · 2002

https://510kreport.com/device/K083117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083117: Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083117

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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