# K024226: Liquichek Anti-SCL-70 Control, Positive, Catalog #116

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 10, 2003 after 18 days
- Product code: LKJ (Antinuclear Antibody, 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 K954723 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984475: Liquichek Anti-SCL-70 Control, Eia, Model 212, Bio-Rad (1998) Summary page 1.

## Indications for use
Liquichek Anti-Scl-70, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 autoantibodies.

Source page: https://510kreport.com/device/K024226
Methodology: https://510kreport.com/methodology