# K123261: Euroimmun Anti-NRNP/SM Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Jun 12, 2013 after 237 days
- Product code: LKO (Anti-Rnp Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922833 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981237: Quanta Lite Ribosome P Elisa, Inova Diagnostics, Inc. (1998) Summary page 36.
- K922833: Quanta Lite RNP Elisa, Inova Diagnostics, Inc. (1992) Summary page 1.
- K922831: Quanta Lite SM Elisa, Inova Diagnostics, Inc. (1992) Summary page 6.
- K922830: Quanta Lite SS-a Elisa, Inova Diagnostics, Inc. (1992) Summary page 11.
- K922832: Quanta Lite SS-B Elisa, Inova Diagnostics, Inc. (1992) Summary page 16.
- K924898: Quanta Lite (TM) SCL-70 Elisa, Inova Diagnostics, Inc. (1992) Summary page 21.
- K926562: Quanta Lite (TM) JO-1 Elisa Kit, Inova Diagnostics, Inc. (1993) Summary page 31.

## Cited in the summary but kept off the family tree
- K003959: Quanta Lite Centromere (Cenp-a & Cenp-B) Elisa, Inova Diagnostics, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K140224: Euroimmun Euroline Ena Profile 9AG (Igg) (2014), 0 descendants of its own

## Indications for use
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 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.

Source page: https://510kreport.com/device/K123261
Methodology: https://510kreport.com/methodology