# K993109: Varelisa Recombi Ana Profile

- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Profile: named in the summary without a submission number
- (no number) Varelisa dsDNA Antibodies Assay: named in the summary without a submission number

## Most influential descendants
- K050625: Varelisa Recombi Ana Profile, Model 18496 (2005), 0 descendants of its own

## Indications for use
The Varelisa ReCombi ANA Profile 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 Profile individually detects antibodies against dSSDNA, RNP(68 kDa, A, C), Sm(B,B',D) SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, Centromere and Jo-1.

Source page: https://510kreport.com/device/K993109
Methodology: https://510kreport.com/methodology