510(k) · Cleared
ClearedReaads Von Willebrand Factor Activity Test Kit, Model 10826
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corgenix, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Apr 5, 2004 as substantially equivalent to K000398 (Shield Diagnostics, Ltd., 2000) after a 269-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 5, 2004
- Review
- 269 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000398 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000398 Shield Von Willebrand Factor Activity Elisa, Model FVWF 200Shield Diagnostics, Ltd. · 2000
- This deviceK032139 Reaads Von Willebrand Factor Activity Test Kit, Model 10826Corgenix, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200 | Shield Diagnostics, Ltd. | 2000 | — |
| 0 (this device) | K032139 | Reaads Von Willebrand Factor Activity Test Kit, Model 10826 | Corgenix, 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 GGP? 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 GGP device
- #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200Summary page 1…Test Kit is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is Shield von Wilebrand Factor Activity Kit (K000398) currently manufactured and marketed by Shield Diagnostics., Dundee, Scotland. The REAADS von Willebrand Factor Activity Test K… | 2000 |
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 K000398.
How does its category compare?
All GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GGP
153in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGP
3in 2025
MAUDE reports naming product code GGP, 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 | 3 | 153 | 2 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma.
The REAADS von Willebrand Factor Activity Test Kit is intended to be used by clinical (hospital and reference) laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032139: Reaads Von Willebrand Factor Activity Test Kit, Model 10826.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032139
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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