510(k) · Cleared
ClearedIndirect Fluorescence Assay for Anti-Nuclear Antibodies Igg Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellar Bio Systems, Inc. · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Apr 21, 1999 after a 34-day review. The FDA summary names no predicate by number.
- Decided
- Apr 21, 1999
- Review
- 34 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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?
The FDA summary names no predicate by number.
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.
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?
The Stellar Bio Systems’ Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglabulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990915 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990915: Indirect Fluorescence Assay for Anti-Nuclear Antibodies Igg Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990915
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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