# K034013: Reaads Dsdna Quantitative Test Kit, Model 022-001

- Pathway: 510(k) (Special)
- Applicant: Corgenix, Inc.
- Decided: Jan 8, 2004 after 15 days
- Product code: LKJ (Antinuclear Antibody, Antigen, 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
For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K034013
Methodology: https://510kreport.com/methodology