510(k) · Cleared
ClearedNOVA Lite DAPI dsDNA Crithidia luciliae Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · KTL Anti-Dna Indirect Immunofluorescent Solid Phase
Cleared on Dec 11, 2020 as substantially equivalent to K880742 (Inova Diagnostics, Inc., 1988) after a 423-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Dec 11, 2020
- Review
- 423 days
- Class
- Class II
- Product code
- KTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880742 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880742 Nova Lite (TM) DsdnaInova Diagnostics, Inc. · 1988
- This deviceK192916 NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880742 | Nova Lite (TM) Dsdna | Inova Diagnostics, Inc. | 1988 | — |
| 0 (this device) | K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K880742 | Nova Lite (TM) DsdnaSummary page 6…NOVA Lite® DAPI dsDNA Crithidia luciliae Kit Page 3 of 19 Predicate device NOVA Lite ™ DSDNA, 510(k) number: k880742 Device description The NOVA Lite DAPI dsDNA Crithidia luciliae Kit is an indirect immunofluorescence assay for the qualitative d… | 1988 |
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. 2020, this device’s year, is highlighted.
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?
NOVA Lite® DAPI dsDNA Crithidia luciliae is an indirect immunofluorescent assay for the qualitative and/or semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies in human serum by NOVA View Automated Fluorescence Microscope or manual fluorescence microscopy. The presence of anti-dsDNA can be used in conjunction with other serological and clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE). All results generated with NOVA View device must be confirmed by a trained operator.
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/K192916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192916: NOVA Lite DAPI dsDNA Crithidia luciliae Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026