# K183007: EliA SmDP Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Dec 24, 2018 after 54 days
- Product code: LKP (Anti-Sm 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 K132631 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132631: Eia SMDP Immunoassay, Phadia US, Inc. (2014) Summary page 6.

## Indications for use
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma to aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 2500/5000.

Source page: https://510kreport.com/device/K183007
Methodology: https://510kreport.com/methodology