# K050967: Varelisa Recombi CTD Screen, Model 13096

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Germany) GmbH
- Decided: Jun 28, 2005 after 71 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
Longest line of descent: 1 generation back to K993108 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993108: Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96, Pharmacia & Upjohn Co. (1999) Summary page 1.

## Indications for use
The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sj6gren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-I in a single microwell.

Source page: https://510kreport.com/device/K050967
Methodology: https://510kreport.com/methodology