# K083188: Varelisa  Recombi Ana Screen, Model 12 596

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Mar 13, 2009 after 135 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 ANA Screen EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sj6gren's syndrome) and polymyositis/ dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against dsDNA, U1RNP (RNP70, A, C), Sm, SS-A/Ro (52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B and Jo-I in a single microwell.

Source page: https://510kreport.com/device/K083188
Methodology: https://510kreport.com/methodology