510(k) · Cleared

Cleared

Euroimmun Anti-NRNP/SM Elisa (Igg)

K123261510(k) TraditionalCleared Jun 12, 2013237-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

Euroimmun US · LKO Anti-Rnp Antibody, Antigen And Control

Cleared on Jun 12, 2013 as substantially equivalent to K981237 (Inova Diagnostics, Inc., 1998) and 6 other predicates after a 237-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Jun 12, 2013
Review: 237 days
Class: Class II
Product code: LKO
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K922833 (1992). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK922833 Quanta Lite RNP ElisaInova Diagnostics, Inc. · 1992
This deviceK123261 Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US · 2013
Descendant · cites it directly · 0 of its ownK140224 Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014

Most influential descendants

Showing 1 of 1 · See all

K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922833	Quanta Lite RNP Elisa	Inova Diagnostics, Inc.	1992	—
0 (this device)	K123261	Euroimmun Anti-NRNP/SM Elisa (Igg)	Euroimmun US	2013	—
+1	K140224	Euroimmun Euroline Ena Profile 9AG (Igg)	Euroimmun US	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	4	0
1993	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K123261, 1992–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K981237	Quanta Lite Ribosome P Elisa Summary page 36 …ate solution and stop solution. Substantial Equivalence Information: 1. 2. Predicate device name (s): Inova Quanta Lite Ribosomal P ELISA Predicate 510(k) number(s): K981237 1100 The American Road, Morris Plains, New Jersey 07950 Page 39 of 47 Tel: 973.656 1000 1.800.913.2022 Fax: 973.656 1098 E-mail:…	Inova Diagnostics, Inc.	1998	—
*	K922833	Quanta Lite RNP Elisa Summary page 1 …mogen/substrate solution and stop solution. Substantial Equivalence Information: 1. Predicate device name (s): Inova Quanta Lite RNP ELISA 2. Predicate 510(k) number(s): K922833 ' . 1100 The American Road, Morris Plains. NJ 07950 ' Page 42 of 50 Tel: 973.4026101 1.800.913.2022 Fax: §73.402 2551 E-mail: in…	Inova Diagnostics, Inc.	1992	—
*	K922831	Quanta Lite SM Elisa Summary page 6 …en/substrate solution and stop solution. . Substantial Equivalence Information: 1. Predicate device name (s): " Inova Quanta Lite Sm ELISA 2. Predicate 510(k) number(s): K922831 1100 The American Road, Morris Plains, New Jersey 07950 Page 41049 Tel: 973.656 1000 1.800.913.2022 Fax: 973.656 1098 E-mait: in…	Inova Diagnostics, Inc.	1992	—
*	K922830	Quanta Lite SS-a Elisa Summary page 11 …n/substrate solution and stop solution. Substantial Equivalence Information: 1. Predicate device name (s): ~ Inova Quanta Lite SS-A ELISA 2. Predicate 510(k) number(s): K922830 1100 The American Road, Morris Plains, New Jersey 07950 Page 41 of 49 Tel: 973.656 1000 1.800.913.2022 Fax; 973.656 1088 E-mail:…	Inova Diagnostics, Inc.	1992	—
*	K922832	Quanta Lite SS-B Elisa Summary page 16 …gen/substrate solution and stop solution. Substantial Equivalence Information: 1. Predicate device name (s): Inova Quanta Lite SS-B ELISA 2. Predicate 510(k) number(s): K922832 1100 The American Road, Morris Plains, New Jersey 07950 Page 41 of 49 Tel; 973.656 1000 1.800.913.2022 Fax: 973.656 1098 E-mail:…	Inova Diagnostics, Inc.	1992	—
*	K924898	Quanta Lite (TM) SCL-70 Elisa Summary page 21 …en/substrate solution and stop solution. Substantial Equivalence Information: 1. Predicate device name (s): Inova Quanta Lite Scl-70 ELISA 2. Predicate 510(k) number(s): K924898 1100 The American Road, Morris Plains, New Jersey 07950 Page 40 of 48 Tel: 973.656 1000 1.800.913.2022 Fax: 973.656 1098 E-mail:…	Inova Diagnostics, Inc.	1992	—
Kept off the family tree	K003959	FDA’s K003959 is Quanta Lite Centromere (Cenp-a & Cenp-B) Elisa Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Inova Diagnostics, Inc.	2001	—
*	K926562	Quanta Lite (TM) JO-1 Elisa Kit Summary page 31 …gen/substrate solution and stop solution. Substantial Equivalence Information: 1. Predicate device name (s):. Inova Quanta Lite Jo-1 ELISA 2. Predicate 510(k) number(s): K926562 1100 The American Road, Morris Plains, New Jersey 07950 Page 41 of 49 Tel: 973.656 1000 1.800.913.2022 Fax: 973.656 1098 E-mail:…	Inova Diagnostics, Inc.	1993	—

Also cleared against K981237: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K140224	Euroimmun Euroline Ena Profile 9AG (Igg)	Euroimmun US	2014	0

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 7 ancestors has a recall.
Of its descendants, K140224 (Euroimmun US, 2014) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K981237.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · LKO

1in 2019

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against ribosomal P-proteins in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings. The EUROIMMUN Anti-nRNP/Sm ELISA (IgG) test kit is intended for the qualitative determination of IgG class…

Read the full statement (402 words)

The EUROIMMUN Anti-nRNP/Sm ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against nRNP/Sm in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Sm ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Sm in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-SS-A ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against SS-A in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of Sjégren’s syndrome and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-SS-B ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against SS-B in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of Sjégren’s syndrome and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Scl-70 ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Scl-70 in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Centromeres ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against centromeres in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of limited form of progressive systemic sclerosis (CREST syndrome), in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Jo-1 ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Jo-1 in human serum and plasma (EDTA, Li-heparin, Citrate). it is used as an aid in the diagnosis of polymyositis and dermatomyasitis, in conjunction with other laboratory and clinical findings.

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/K123261 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123261: Euroimmun Anti-NRNP/SM Elisa (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123261

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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