# K962276: Hemagen Ena Dsdna Kit (Eia Method)

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Dec 5, 1996 after 175 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: 1 generation back to K771376 (1977). 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)
- K771376: Ifa Anti-Ndna, Electro-Nucleonics Laboratories, Inc. (1977) Summary page 1.

## Indications for use
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating antibodies to native DNA. These autoantibodies are often associated with systemic lupus erythematosus (SLE) and give positive results in screening tests for antinuclear antibodies.

Source page: https://510kreport.com/device/K962276
Methodology: https://510kreport.com/methodology