# K131791: Ifa 40: Hep-20-10

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Feb 26, 2014 after 253 days
- Product code: DHN (Antinuclear Antibody, Indirect Immunofluorescent, 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
Longest line of descent: 3 generations back to K935129 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972145: Hep-2000 Fluorescent Ana-RO Test System, Immuno Concepts, Inc. (1998) Summary page 2.

## Indications for use
The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K131791
Methodology: https://510kreport.com/methodology