510(k) · Cleared
ClearedMesacup Test PR-3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhigene, Inc. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Apr 2, 2004 as substantially equivalent to K981029 (The Binding Site, Ltd., 1998) after a 15-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 2, 2004
- Review
- 15 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 deviceK040711 Mesacup Test PR-3Rhigene, Inc. · 2004
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) | K040711 | Mesacup Test PR-3 | Rhigene, Inc. | 2004 | — |
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…ompared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is lindazyme Human An/i-PR3 Enzyme Immunoassay Kit (K981029) currently manufactured and marketed by The Binding Site Ltd., Birminghamn. U.K The MESACUP TcesPR-3 is an eor.zymc4inked im… | 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?
The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis.
The MESACUP TEST PR-3 is intended to be used by clinical (hospital and reference) laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040711: Mesacup Test PR-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040711
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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