# K984397: Liquichek Ana Control, Centromere Pattern, Model 203

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 18, 1998 after 9 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 K813592 (1982). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813592: Quantafluor Fluorescent Test Reagents, Kallestad Laboratories, Inc. (1982) Summary page 1.

## Most influential descendants
- K024230: Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131 (2003), 0 descendants of its own
- K024222: Liquichek Ana Control Centromere Pattern, Positive, Catalog #112 (2003), 0 descendants of its own

## Indications for use
Liquichek ANA Control, Centromere Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Source page: https://510kreport.com/device/K984397
Methodology: https://510kreport.com/methodology