510(k) · Cleared
ClearedBindazyme Anti-PR3 Enzyme Immunoassay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Jul 20, 1998 after a 123-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jul 20, 1998
- Review
- 123 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK981029 Bindazyme Anti-PR3 Enzyme Immunoassay KitThe Binding Site, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK040711 Mesacup Test PR-3Rhigene, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK013283 Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model #…Immuno Concepts, Inc. · 2001
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) | K981029 | Bindazyme Anti-PR3 Enzyme Immunoassay Kit | The Binding Site, Ltd. | 1998 | — |
| +1 | K040711 | Mesacup Test PR-3 | Rhigene, Inc. | 2004 | — |
| +1 | K013283 | Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16 | Immuno Concepts, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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 MOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOB device
- #1 K261466 Alegria Flash MPO; Alegria Flash PR3; Alegria…score 11.9 · 1 generation · no Class I recall
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, K040711 (Rhigene, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MOB devicesMOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOB
221in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOB
1in 2012
MAUDE reports naming product code MOB, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 379 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 221 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This assay is designed for the in-vitro measurement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis in conjunction with other clinical findings.
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/K981029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981029: Bindazyme Anti-PR3 Enzyme Immunoassay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981029
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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