# K202540: EliA Rib-P

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Sep 13, 2021 after 376 days
- Product code: MQA (Anti-Ribosomal P Antibodies)
- 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 K981237 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981237: Quanta Lite Ribosome P Elisa, Inova Diagnostics, Inc. (1998) Summary page 6.

## Most influential descendants
- K253367: EliA CTD 13 Screen (2026), 0 descendants of its own

## Indications for use
EliA Rib-P is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Rib-P uses the EliA IgG method.

Source page: https://510kreport.com/device/K202540
Methodology: https://510kreport.com/methodology