# K024219: Liquichek Anti-SM Control, Positive, Catalog #115

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 15, 2003 after 23 days
- Product code: LKP (Anti-Sm Antibody, Antigen And 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)
- K984479: Liquichek Anti-SM Control, Eia, Model 208, Bio-Rad (1998) Summary page 1.

## Indications for use
Liquichek Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.

Source page: https://510kreport.com/device/K024219
Methodology: https://510kreport.com/methodology