# K024220: Liquichek Autoimmune Negative Control, Catalog #130

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 17, 2003 after 25 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 K780899 (1978). 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)
- K780899: Fluorescent Anti-Native Dna Test, Kallestad Laboratories, Inc. (1978) Summary page 1.

## Indications for use
The Liquichek Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert

Source page: https://510kreport.com/device/K024220
Methodology: https://510kreport.com/methodology