# K990915: Indirect Fluorescence Assay for Anti-Nuclear Antibodies Igg Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Stellar Bio Systems, Inc.
- Decided: Apr 21, 1999 after 34 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, 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 no predicate by number.

## Indications for use
The Stellar Bio Systems’ Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglabulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases.

Source page: https://510kreport.com/device/K990915
Methodology: https://510kreport.com/methodology