510(k) · Cleared
ClearedImage Navigator by Immuno Concepts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno Concepts, N.A., Ltd. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Jun 17, 2016 after a 136-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 17, 2016
- Review
- 136 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DHN devicesDHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DHN
Too few DHN 510(k)s in any year since 2007 to give a median.
Recalls per year · DHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHN
No MAUDE report names DHN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Instrument The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital images of stained indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be…
Read the full statement (208 words)
Instrument
The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that
acquires, interprets, stores, and displays digital images of stained indirect immunofluorescent slides. The Image Navigator
can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the
microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory
personnel.
Assay
This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in
human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope.
This test system uses transfectedt HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro
antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is
present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present.
Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies.
This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in
conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image
Navigator semi-automated device and software.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160265: Image Navigator by Immuno Concepts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160265
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026