510(k) · Cleared
ClearedIgg Anti-Ndna Fluorescent Test System; Model # 3040G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno Concepts, Inc. · KTL Anti-Dna Indirect Immunofluorescent Solid Phase
Cleared on Nov 29, 2001 as substantially equivalent to K930987 (The Binding Site, Ltd., 1993) after a 45-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 29, 2001
- Review
- 45 days
- Class
- Class II
- Product code
- KTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930987 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930987 Crithidia Lucilliae DS Dna Kit (Diagnostic Use)The Binding Site, Ltd. · 1993
- This deviceK013432 Igg Anti-Ndna Fluorescent Test System; Model # 3040GImmuno Concepts, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930987 | Crithidia Lucilliae DS Dna Kit (Diagnostic Use) | The Binding Site, Ltd. | 1993 | — |
| 0 (this device) | K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040G | Immuno Concepts, Inc. | 2001 | — |
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 |
|---|---|---|---|
| * | K930987 | Crithidia Lucilliae DS Dna Kit (Diagnostic Use)Summary page 1…e with which this device has been shown to be equivalent: "crithidia lucilliae DS DNA Kit (Diagnostic Use)" distributed by The Binding Site, Ltd., Los Angeles, CA 90064 (K930987, 8/10/93). Description: This is an indirect fluorescent antibody test for screening and semi- quantitative detection of IgG ant… | 1993 |
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.
What does this lineage say?
- Its one ancestor has no 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?
This is an indirect fluorescent antibody test for screening and semi-quantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.
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/K013432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013432: Igg Anti-Ndna Fluorescent Test System; Model # 3040G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013432
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026