510(k) · Cleared
ClearedRelisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno Concepts, Inc. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Nov 14, 2001 as substantially equivalent to K981029 (The Binding Site, Ltd., 1998) after a 43-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 14, 2001
- Review
- 43 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981029 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981029 Bindazyme Anti-PR3 Enzyme Immunoassay KitThe Binding Site, Ltd. · 1998
- This deviceK013283 Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model #…Immuno Concepts, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981029 | Bindazyme Anti-PR3 Enzyme Immunoassay Kit | The Binding Site, Ltd. | 1998 | — |
| 0 (this device) | K013283 | Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16 | Immuno Concepts, Inc. | 2001 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K981029 | Bindazyme Anti-PR3 Enzyme Immunoassay KitSummary page 1…evice with which this device has been shown to be equivalent: Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK, K981029. Description: This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum. Intended Use… | 1998 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K981029.
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 is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener‘s granulomatosis and other vasculitides.
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/K013283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013283: Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013283
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026