# K993294: Diamedix IS-Ana Elisa Screen Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Oct 25, 1999 after 24 days
- Product code: LKJ (Antinuclear Antibody, Antigen, 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
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) Diamedix Immunosimplicity ANA (Is-ANA) Screen Test: named in the summary without a submission number

## Indications for use
The Diamedix Immunosimplicity (Is) ANA ELISA ScreenTest Kit is a qualitative enzyme immunoassay intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double-stranded DNA (dsDNA and nDNA), Histones, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IF) HEp-2 ANAs. These reagents can be used either manually or in conjunction with the MAGO Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K993294
Methodology: https://510kreport.com/methodology