# K140224: Euroimmun Euroline Ena Profile 9AG (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Dec 9, 2014 after 314 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: 2 generations back to K922833 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123261: Euroimmun Anti-NRNP/SM Elisa (Igg), Euroimmun US (2013) Summary page 5.
- K063565: Quanta Lite SS-a 52 Elisa, Inova Diagnostics, Inc. (2007) Summary page 5.

## Indications for use
The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal P-proteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-/dermatomyositis, mixed connective tissue disease and Sjogren’s syndrome, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) test kit is intended to be used in a clinical, reference or hospital laboratory. This kit is not designed for point-of-care testing.

Source page: https://510kreport.com/device/K140224
Methodology: https://510kreport.com/methodology