510(k) · Cleared
ClearedQuanta Lite GBM Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Cleared on Feb 8, 1999 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 8, 1999
- Review
- 67 days
- Class
- Class II
- Product code
- MVJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK984336 Quanta Lite GBM ElisaInova Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK072358 Bioplex Vasculitis KitBio-Rad Laboratories · 2007
Most influential descendants
Showing 1 of 1 · See all- K072358Bioplex Vasculitis KitBio-Rad Laboratories · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984336 | Quanta Lite GBM Elisa | Inova Diagnostics, Inc. | 1999 | — |
| +1 | K072358 | Bioplex Vasculitis Kit | Bio-Rad Laboratories | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 MVJ? 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 |
|---|---|---|---|
| K072358 | Bioplex Vasculitis Kit | 2007 | 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, K072358 (Bio-Rad Laboratories, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MVJ devicesMVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVJ
2in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MVJ
Too few MVJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MVJ
No recall names MVJ since 2007.
Adverse event reports per year · MVJ
1in 2025
MAUDE reports naming product code MVJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 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 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984336: Quanta Lite GBM Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984336
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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