510(k) · Cleared
ClearedQuanta Lite GP210 Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · NRI Autoantibodies, Nuclear Pore Glycoprotein Gp210
Cleared on Jun 25, 2004 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 25, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- NRI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040885 Quanta Lite GP210 ElisaInova Diagnostics, Inc. · 2004
- 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) | K040885 | Quanta Lite GP210 Elisa | Inova Diagnostics, Inc. | 2004 | — |
| +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 NRI? 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 NRI devicesNRI Autoantibodies, Nuclear Pore Glycoprotein Gp210: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRI
FDA has decided no NRI device since 2007.
Median 510(k) review, days · NRI
Too few NRI 510(k)s in any year since 2007 to give a median.
Recalls per year · NRI
No recall names NRI since 2007.
Adverse event reports per year · NRI
No MAUDE report names NRI 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 Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-gp210 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/K040885 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040885: Quanta Lite GP210 Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040885
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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