510(k) · Cleared
ClearedQuanta Lite LKM-1 Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Cleared on Jun 7, 2000 after a 111-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 7, 2000
- Review
- 111 days
- Class
- Class II
- Product code
- NBS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK000535 Quanta Lite LKM-1 ElisaInova Diagnostics, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK163538 QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators…Inova Diagnostics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK113439 Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013
- Descendant · cites it directly · 0 of its ownK112223 Euroimmun Anti-LKM-1 Elisa (LGG)Euroimmun US · 2012
Most influential descendants
Showing 3 of 3 · See all- K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1…Inova Diagnostics, Inc. · 2017 · cites it directly0descendants
- K113439Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013 · cites it directly0descendants
- K112223Euroimmun Anti-LKM-1 Elisa (LGG)Euroimmun US · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000535 | Quanta Lite LKM-1 Elisa | Inova Diagnostics, Inc. | 2000 | — |
| +1 | K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash®… | Inova Diagnostics, Inc. | 2017 | — |
| +1 | K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | Euroimmun US | 2013 | — |
| +1 | K112223 | Euroimmun Anti-LKM-1 Elisa (LGG) | Euroimmun US | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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 NBS? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 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, K163538 (Inova Diagnostics, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NBS devicesNBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NBS
Too few NBS 510(k)s in any year since 2007 to give a median.
Recalls per year · NBS
No recall names NBS since 2007.
Adverse event reports per year · NBS
No MAUDE report names NBS 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 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/K000535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000535: Quanta Lite LKM-1 Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000535
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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