# K993108: Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Nov 12, 1999 after 56 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Varelisa® ANA-8-Screen: named in the summary without a submission number

## Most influential descendants
- K083188: Varelisa  Recombi Ana Screen, Model 12 596 (2009), 0 descendants of its own
- K050967: Varelisa Recombi CTD Screen, Model 13096 (2005), 0 descendants of its own

## 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 (Sjogren's Syndrome) and Polymyositis/ Dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against d3SDNA, RNP(68kDa, A, C), Sm(B,B',D) SS-A/Ro(52kDa, 60kDa), SS-B/La, Scl-70, Centromere and Jo-1 in a single microwell.

Source page: https://510kreport.com/device/K993108
Methodology: https://510kreport.com/methodology