# K040810: Varelisa Histone Antibodies, Model 16496

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Deutschland GmbH
- Decided: May 14, 2004 after 46 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.
No later device cites it as a predicate yet.
0 of 1 device 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) INOVA QUANTA Lite Histone IgG: named in the summary without a submission number

## Indications for use
The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or drug-induced lupus erythematosus (DIL).

Source page: https://510kreport.com/device/K040810
Methodology: https://510kreport.com/methodology