# K944172: Varelisa SCL-70 Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Elias U.S.A., Inc.
- Decided: Dec 22, 1994 after 118 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- 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
- K083117: Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01 (2009), 1 descendant of its own
- K071210: Modification to Fidis Connective 10*, Model MX006 (2007), 1 descendant of its own
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K944172
Methodology: https://510kreport.com/methodology