510(k) · Cleared
ClearedIndirect Fluorescence Assay for Anti-Native Dna Igg Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellar Bio Systems, Inc. · KTL Anti-Dna Indirect Immunofluorescent Solid Phase
Cleared on Apr 21, 1999 after a 34-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 21, 1999
- Review
- 34 days
- Class
- Class II
- Product code
- KTL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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 KTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KTL device
- #1 K192916 NOVA Lite DAPI dsDNA Crithidia luciliae Kitscore 0.5 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | nDNA IFA Named without a submission 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 KTL devicesKTL Anti-Dna Indirect Immunofluorescent Solid Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTL
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KTL
Too few KTL 510(k)s in any year since 2007 to give a median.
Recalls per year · KTL
No recall names KTL since 2007.
Adverse event reports per year · KTL
No MAUDE report names KTL 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 | — | 0 | 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 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 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 Anti-native DNA (nDNA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to nDNA in human serum. Detection of nDNA IgG antibody in humans can be used as an aid in the diagnosis of systemijc lupus erythematosus (SLE).
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/K990916 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990916: Indirect Fluorescence Assay for Anti-Native Dna 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/K990916
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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