# K040953: Aeskulisa Ana Hep-2

- Pathway: 510(k) (Traditional)
- Applicant: Aesku, Inc.
- Decided: Jun 23, 2004 after 72 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131330: Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit (2014), 0 descendants of its own

## Indications for use
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A(Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K040953
Methodology: https://510kreport.com/methodology