510(k) · Cleared
ClearedNOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Feb 3, 2017 as substantially equivalent to K961340 (Inova Diagnostics, Inc., 1996) after a 275-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Feb 3, 2017
- Review
- 275 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961340 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961340 Nova Lite AncaInova Diagnostics, Inc. · 1996
- This deviceK161258 NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961340 | Nova Lite Anca | Inova Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Inova Diagnostics, Inc. | 2017 | — |
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 MOB? 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 MOB device
- #1 K261466 Alegria Flash MPO; Alegria Flash PR3; Alegria…score 11.9 · 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 |
|---|---|---|---|
| * | K961340 | Nova Lite AncaSummary page 7…ntended to be used by itself, but in conjunction with ANCA Ethanol test. 8. Indications for Use Same as intended use. 9. Predicate device NOVA Lite ANCA; 510k number: K961340 10. Comparison matrix to predicate device Item NOVA Lite DAPI ANCA Ethanol and Predicate Device… | 1996 |
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.
- 3 other devices also cite its predicate K961340.
How does its category compare?
All MOB devicesMOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MOB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOB
221in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOB
1in 2012
MAUDE reports naming product code MOB, not matched to any one device; reports are not rates.
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 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 379 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 221 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA…
Read the full statement (168 words)
NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device.
NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test.
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/K161258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161258: NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161258
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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