# K042629: Varelisa SM Antibodies, Model 18296

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Germany) GmbH
- Decided: Dec 8, 2004 after 72 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: 1 generation back to K000312 (2000). 1 ancestor in all.
7 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)
- K000312: Varelisa SM Antibodies, Pharmacia & Upjohn Co. (2000) Summary page 1.

## 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
- 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
- K180975: QUANTA Flash HMGCR Reagents (2018), 0 descendants of its own

## Indications for use
The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).

Source page: https://510kreport.com/device/K042629
Methodology: https://510kreport.com/methodology