# K024151: EL-Ana Profiles: Anti-Ribosomal Protein P

- Pathway: 510(k) (Traditional)
- Applicant: Theratest Laboratories, Inc.
- Decided: Feb 6, 2003 after 62 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EL-ANA ProfilesTM is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P, and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.

Source page: https://510kreport.com/device/K024151
Methodology: https://510kreport.com/methodology