# K030929: Ana Detect

- Pathway: 510(k) (Traditional)
- Applicant: Orgentec Diagnostika GmbH
- Decided: May 2, 2003 after 39 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ORGENTEC ANA Detect assay is a qualitative enzyme immunoassay (EIA) 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, ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-NRo, SS-A-La, Sm, SmRNP, Scl-70, Jo-1, and centromeric antigens.

Source page: https://510kreport.com/device/K030929
Methodology: https://510kreport.com/methodology