# K000312: Varelisa SM Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Mar 17, 2000 after 45 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042629: Varelisa SM Antibodies, Model 18296 (2004), 7 descendants of its own
- K053653: Fidis Connective 10, Model MX006 (2006), 5 descendants of its own
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (2016), 2 descendants of its own
- K082759: Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay (2009), 1 descendant of its own
- K071210: Modification to Fidis Connective 10*, Model MX006 (2007), 1 descendant of its own

Source page: https://510kreport.com/device/K000312
Methodology: https://510kreport.com/methodology