# K990916: Indirect Fluorescence Assay for Anti-Native Dna Igg Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Stellar Bio Systems, Inc.
- Decided: Apr 21, 1999 after 34 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
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) nDNA IFA: named in the summary without a submission number

## Indications for use
The Stellar Bio Systems’ Indirect Fluorescence Assay (IFA) for Anti-native DNA (nDNA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to nDNA in human serum. Detection of nDNA IgG antibody in humans can be used as an aid in the diagnosis of systemijc lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K990916
Methodology: https://510kreport.com/methodology