510(k) · Cleared
ClearedQuanta Lite Sla (Soluble Liver Antigen) Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Cleared on Jul 30, 2002 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jul 30, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- NIY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK021482 Quanta Lite Sla (Soluble Liver Antigen) ElisaInova Diagnostics, Inc. · 2002
- 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 ownK112221 Euroimmun Anti-Sla/LP Elisa (LGG)Euroimmun US · 2012
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) | K021482 | Quanta Lite Sla (Soluble Liver Antigen) Elisa | Inova Diagnostics, Inc. | 2002 | — |
| +1 | K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | Euroimmun US | 2013 | — |
| +1 | K112221 | Euroimmun Anti-Sla/LP Elisa (LGG) | Euroimmun US | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NIY? 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’s file for it is a 510(k) statement, which names no predicate.
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, K113439 (Euroimmun US, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NIY devicesNIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · NIY
Too few NIY 510(k)s in any year since 2007 to give a median.
Recalls per year · NIY
No recall names NIY since 2007.
Adverse event reports per year · NIY
No MAUDE report names NIY 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 | 1 | — | 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 | — |
What is it indicated for?
The QUANTA LiteTMSLA (soluble liver antigen) kit is an enzyme-linked irnrnunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AI H).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021482: Quanta Lite Sla (Soluble Liver Antigen) Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021482
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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