510(k) · Cleared
ClearedBioplex Vasculitis Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Cleared on Oct 31, 2007 as substantially equivalent to K041040 (Sweden Diagnostics (Germany) GmbH, 2004) and 3 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 31, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- MVJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K961340 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961340 Nova Lite AncaInova Diagnostics, Inc. · 1996
- This deviceK072358 Bioplex Vasculitis KitBio-Rad Laboratories · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961340 | Nova Lite Anca | Inova Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K072358 | Bioplex Vasculitis Kit | Bio-Rad Laboratories | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041040 | Varelisa Mpo Anca, Model 17648/17696Summary page 2…Decision PREDICATE DEVICE Date Phadia Varelisa T M MPO EIA K041040 06/16/04 Phadia Varelisa T M PR3 EIA K041043 07/02/04 INOVA QUANTA… | 2004 |
| * | K041043 | Varelisa PR3 Anca, Model Number 17748/17796Summary page 2…Date Phadia Varelisa T M MPO EIA K041040 06/16/04 Phadia Varelisa T M PR3 EIA K041043 07/02/04 INOVA QUANTA Lite TM GBM ELISA K984336 02/08199 INOVA NOVA L… | 2004 |
| * | K984336 | Quanta Lite GBM ElisaSummary page 2…16/04 Phadia Varelisa T M PR3 EIA K041043 07/02/04 INOVA QUANTA Lite TM GBM ELISA K984336 02/08199 INOVA NOVA Lite ANCA (Ethanol-fixed Slides) K961340 07/10/96 DEVICE DESCR… | 1999 |
| * | K961340 | Nova Lite AncaSummary page 2…02/04 INOVA QUANTA Lite TM GBM ELISA K984336 02/08199 INOVA NOVA Lite ANCA (Ethanol-fixed Slides) K961340 07/10/96 DEVICE DESCRIPTION The Vasculitis kit uses multiplex flow immunoassay, a methodology that greatly resembles… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 4 ancestors has a recall.
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. 2007, this device’s year, is highlighted.
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?
The BioPlexTM 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), serine Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum. The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System. Uses: The test system is used to detect the presence of antibodies in serum samples, as an aid in the diagnosis of certain…
Read the full statement (172 words)
The BioPlexTM 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), serine Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum.
The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System.
Uses:
The test system is used to detect the presence of antibodies in serum samples, as an aid in the diagnosis of certain autoimmune vasculitides such as Microscopic Polyangiitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and autoimmune renal disorders, such as Goodpasture's syndrome, in conjunction with clinical findings and other laboratory tests.
The BioPlex 2200 Vasculitis Calibrator Set is intended for the calibration of the BioPlex 2200 Vasculitis Reagent Pack.
The BioPlex 2200 Vasculitis Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Vasculitis Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Vasculitis Control Set has not been established with any other Vasculitis assays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K072358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072358: Bioplex Vasculitis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072358
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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