# K043067: Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400

- Pathway: 510(k) (Traditional)
- Applicant: Bioarray Solutions, Ltd.
- Decided: May 31, 2005 after 204 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- 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 K964787 (1997). 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)
- K964787: Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System, Mardx Diagnostics, Inc. (1997) Summary page 1.

## Indications for use
The BioArray Solutions ENA IgG BeadChip Tm Test System is intended for use in testing human serum for the presence of human IgG class antibodies to six extractable nuclear antigens, SSA, SSB, Sm, Sm/RNP, Scl-70, and Jo-l. The presence of these autoantibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus, Sj6gren's syndrome, scleroderma and myositis. This ENA IgG BeadChip is for use with Array Imaging System 400 (AIS400). This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K043067
Methodology: https://510kreport.com/methodology