510(k) · Cleared
ClearedVisulize Factor Viii Antigen Kit, Model Fviii-AG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Affinity Biologicals, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Jan 20, 2006 as substantially equivalent to K981038 (Instrumentation Laboratory CO, 1998) after a 107-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Jan 20, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K833892 (1984). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K981038 | Coamatic Factor ViiiSummary page 1…Subpart H, Hematology Kits and Packages Product Code: GGP Predicate Device: Coamatic® Factor VIII, K981038 Instrumentation Laboratory Co. Device Description: The VisuLizeTM Factor VIII… | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- None of the 2 ancestors has a recall.
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 VisuLize TM Factor VIII Antigen Kit is intended for use as an in vitro diagnostic assay
for the quantitative determination of Factor VIII antigen in human plasma samples and
Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay
(ELISA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052825: Visulize Factor Viii Antigen Kit, Model Fviii-AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052825
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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