510(k) · Cleared
ClearedHistofluor Rodent LKS Fluorescent Antibody Test System, Image 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. · DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Cleared on Oct 19, 2018 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 19, 2018
- Review
- 268 days
- Class
- Class II
- Product code
- DBL
- 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 DBL? 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 DBL devicesDBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DBL
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DBL
Too few DBL 510(k)s in any year since 2007 to give a median.
Recalls per year · DBL
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBL
No MAUDE report names DBL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Histofluor Rodent LKS Fluorescent Antibody Test System is intended to be used as an indirect fluorescent antibody test for the qualitative and semi-quantitative detection of autoantibodies associated with autoimmune diseases. It is intended for use with the Image Navigator software and microscope. The results must be interpreted by trained personnel.
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/K180202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180202: Histofluor Rodent LKS Fluorescent Antibody Test System, 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/K180202
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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