# K013213: Hyperion Visiquant Ana Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hyperion, Inc.
- Decided: Jun 4, 2002 after 251 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: 1 generation back to K872845 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872845: Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum, Bion Ent., Ltd. (1987) Summary page 1.

## Most influential descendants
- K022800: Visiquant Anti-Nuclear Antibody Test System (2002), 0 descendants of its own

## Indications for use
The Hyperion VisiQuantTMANA Test Kit 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/K013213
Methodology: https://510kreport.com/methodology