# K024230: Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 15, 2003 after 23 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 K813592 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792610: Kallestad Florescent Ana/Ama/Asma Test, Kallestad Laboratories, Inc. (1980) Summary page 1.
- K984397: Liquichek Ana Control, Centromere Pattern, Model 203, Bio-Rad (1998) Summary page 1.

## Indications for use
The Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Source page: https://510kreport.com/device/K024230
Methodology: https://510kreport.com/methodology