# K051066: Theratest EL-Ana Profiles

- Pathway: 510(k) (Traditional)
- Applicant: Theratest Laboratories, Inc.
- Decided: Oct 7, 2005 after 164 days
- Product code: LKP (Anti-Sm 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
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 Profiles TM is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), SmH R, RNP/Sm, SSA (Ro) HR, SSB (La) HR Histones, Scl-70, Jo-1 HR, Ribosomal Protein P, Centromere HR, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.

Source page: https://510kreport.com/device/K051066
Methodology: https://510kreport.com/methodology