# K974694: IS-Dsdna Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Mar 3, 1998 after 77 days
- Product code: LRM (Anti-Dna Antibody (Enzyme-Labeled), 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. The FDA summary names its predicate without a number.
- (no number) Varelisa dsDNA Antibodies: named in the summary without a submission number

## Indications for use
The Diamedix Is-dsDNA Test System is an enzyme immunoassay (EIA) for the detection and quantitative measurement of IgG antibodies to DNA antigen as an aid in the diagnosis of systemic lupus erythematosus in patients with clinical signs of the disease. These assays are used either manually or in conjunction with the MAGO® Automated EIA Processor.

Source page: https://510kreport.com/device/K974694
Methodology: https://510kreport.com/methodology