# K172745: ImmuGlo HEp-2 Elite IFA

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Jun 5, 2018 after 266 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
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) ImmuGlo ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS): named in the summary without a submission number

## Indications for use
The ImmuGlo HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells and engineered HEp-2 cells as a substrate. The ImmuGlo HEp-2 Elite IFA is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K172745
Methodology: https://510kreport.com/methodology