# K022800: Visiquant Anti-Nuclear Antibody Test System

- Pathway: 510(k) (Traditional)
- Applicant: Hyperion, Inc.
- Decided: Nov 25, 2002 after 94 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
Longest line of descent: 2 generations back to K872845 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013213: Hyperion Visiquant Ana Test Kit, Hyperion, Inc. (2002) Summary page 1.

## Indications for use
The VisiQuant™ Anti-Nuclear Antibody Test System is intended for the visual determination of anti-nuclear antibodies (ANA’s) immunofluorescence pattern(s) and the semi-quantitative measurement of ANA’s in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

Source page: https://510kreport.com/device/K022800
Methodology: https://510kreport.com/methodology