De Novo · Granted
GrantedQuanta Lite Asca (S. Cerevisiae) Igg Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Granted on Aug 16, 2000 as a new device type through De Novo after a 29-day review. 2 later devices descend from it.
- Decided
- Aug 16, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- NBT
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN000007 | Quanta Lite Asca (S. Cerevisiae) Igg Elisa | Inova Diagnostics, Inc. | 2000 | — |
| +1 | K071711 | Asca-Chek | Techlab Inc., Corporate Research Center | 2007 | — |
| +1 | K051927 | Techlab Asca-Chek | Techlab, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA De Novo 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 NBT? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
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, K071711 (Techlab Inc., Corporate Research Center, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NBT devicesNBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBT
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NBT
Too few NBT 510(k)s in any year since 2007 to give a median.
Recalls per year · NBT
No recall names NBT since 2007.
Adverse event reports per year · NBT
No MAUDE report names NBT since 2007.
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 | 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN000007 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN000007: Quanta Lite Asca (S. Cerevisiae) Igg Elisa.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN000007
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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