# K202067: EliA SmDP-S

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Jul 14, 2021 after 352 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-S is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP-S uses the EliA IgG method.

Source page: https://510kreport.com/device/K202067
Methodology: https://510kreport.com/methodology