# K202541: EliA RNA Pol III

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Sep 13, 2021 after 376 days
- Product code: NYO (Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody)
- 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 K070066 (2007). 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)
- K070066: Quanta Lite Rna Pol Iii Elisa, Inova Diagnostics, Inc. (2007) Summary page 6.

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

## Indications for use
EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in conjunction with other laboratory and clinical findings. EliA RNA Pol III uses the EliA IgG method.

Source page: https://510kreport.com/device/K202541
Methodology: https://510kreport.com/methodology