# K210902: EliA Ro52, EliA Ro60

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Jul 27, 2022 after 488 days
- Product code: LKJ (Antinuclear Antibody, Antigen, 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 K962719 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141655: Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls, Inova Diagnostics, Inc. (2015) Summary page 9.
- K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls, Inova Diagnostics, Inc. (2015) Summary page 9.

## Indications for use
EliA Ro52 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro52 in human serum as an aid in the diagnosis of Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM) in conjunction with other laboratory and clinical findings. EliA Ro52 uses the EliA IgG method. EliA Ro60 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro60 in human serum as an aid in the diagnosis of Sjogren's syndrome (SS) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Ro60 uses the EliA IgG method.

Source page: https://510kreport.com/device/K210902
Methodology: https://510kreport.com/methodology