# K253367: EliA CTD 13 Screen

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Jun 25, 2026 after 268 days
- Product code: LLL (Extractable Antinuclear 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: 3 generations back to K880736 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190710: EliA SymphonyS Immunoassay, Phadia AB (2019) Summary page 7.
- K072393: Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01, Phadia US, Inc. (2007) Summary page 7.
- K202540: EliA Rib-P, Phadia AB (2021) Summary page 7.
- K202541: EliA RNA Pol III, Phadia AB (2021) Summary page 7.

## Indications for use
EliA CTD 13 Screen is intended for the in vitro qualitative detection of antinuclear IgG antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE), Sjögren's syndrome (SS), systemic sclerosis (SSc), polymyositis (PM), dermatomyositis (DM) and mixed connective tissue disease (MCTD), in conjunction with other laboratory and clinical findings. EliA CTD 13 Screen detects antibodies against RNP70, U1RNP-A, U1RNP-C, SS-A/Ro60, SS-A/Ro52, SS-B/La, Centromere B, Scl-70, Jo-1, RNA Pol III, Rib-P, Sm and dsDNA. EliA CTD 13 Screen uses the EliA IgG method.

Source page: https://510kreport.com/device/K253367
Methodology: https://510kreport.com/methodology