# K024227: Liquichek Anti-Mitochondrial Control, Positive, Catalog #127

- 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: 1 generation back to K792610 (1980). 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)
- K792610: Kallestad Florescent Ana/Ama/Asma Test, Kallestad Laboratories, Inc. (1980) Summary page 1.

## Indications for use
Liquichek anti-mitochondrial control, positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of mitochondrial autoantibodies.

Source page: https://510kreport.com/device/K024227
Methodology: https://510kreport.com/methodology