510(k) · Cleared
ClearedNova Lite (TM) Ana
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Mar 25, 1988 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 25, 1988
- Review
- 30 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK880736 Nova Lite (TM) AnaInova Diagnostics, Inc. · 1988
- Descendant · cites it directly · 2 of its ownK072149 Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01Phadia US, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK190710 EliA SymphonyS ImmunoassayPhadia AB · 2019
- Descendant · 3 generations on · 0 of its ownK253367 EliA CTD 13 ScreenPhadia AB · 2026
- Descendant · cites it directly · 0 of its ownK150155 NOVA Lite DAPI ANA KitInova Diagnostics, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K072149Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01Phadia US, Inc. · 2008 · cites it directly2descendants
- K190710EliA SymphonyS ImmunoassayPhadia AB · 2019 · 2 generations on1descendant
- K253367EliA CTD 13 ScreenPhadia AB · 2026 · 3 generations on0descendants
- K150155NOVA Lite DAPI ANA KitInova Diagnostics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880736 | Nova Lite (TM) Ana | Inova Diagnostics, Inc. | 1988 | — |
| +1 | K072149 | Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01 | Phadia US, Inc. | 2008 | — |
| +2 | K190710 | EliA SymphonyS Immunoassay | Phadia AB | 2019 | — |
| +3 | K253367 | EliA CTD 13 Screen | Phadia AB | 2026 | — |
| +1 | K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLL? 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 LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072149 (Phadia US, Inc., 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K880736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880736: Nova Lite (TM) Ana.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880736
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026