# K013432: Igg Anti-Ndna Fluorescent Test System; Model # 3040G

- Pathway: 510(k) (Traditional)
- Applicant: Immuno Concepts, Inc.
- Decided: Nov 29, 2001 after 45 days
- Product code: KTL (Anti-Dna Indirect Immunofluorescent Solid Phase)
- 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
Longest line of descent: 1 generation back to K930987 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930987: Crithidia Lucilliae DS Dna Kit (Diagnostic Use), The Binding Site, Ltd. (1993) Summary page 1.

## Indications for use
This is an indirect fluorescent antibody test for screening and semi-quantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.

Source page: https://510kreport.com/device/K013432
Methodology: https://510kreport.com/methodology