# K013263: Fred Hutchinson Cancer Research Center Enzyme Anti-SR Protein Antibody Test

- Pathway: 510(k) (Traditional)
- Applicant: Fred Hutchinson Cancer Research Center
- Decided: Jul 29, 2002 after 301 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 Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semi-quantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins. The test is intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE).

Source page: https://510kreport.com/device/K013263
Methodology: https://510kreport.com/methodology