510(k) · Cleared
ClearedQuanta Lite SP100 Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NUM Autoantibodies, Nuclear Body Protein, Sp100
Cleared on Jun 13, 2005 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 13, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- NUM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050662 Quanta Lite SP100 ElisaInova Diagnostics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK113439 Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013
Most influential descendants
Showing 1 of 1 · See all- K113439Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050662 | Quanta Lite SP100 Elisa | Inova Diagnostics, Inc. | 2005 | — |
| +1 | K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | Euroimmun US | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NUM? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | 2013 | 0 |
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 NUM devicesNUM Autoantibodies, Nuclear Body Protein, Sp100: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUM
FDA has decided no NUM device since 2007.
Median 510(k) review, days · NUM
Too few NUM 510(k)s in any year since 2007 to give a median.
Recalls per year · NUM
No recall names NUM since 2007.
Adverse event reports per year · NUM
No MAUDE report names NUM 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 | 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 | — |
What is it indicated for?
The QUANTA LiteTM sp1iO kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050662: Quanta Lite SP100 Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050662
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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