510(k) · Cleared
ClearedVisulize Factor IX Antigen Kit
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 Jun 29, 2005 as substantially equivalent to K854312 (American Bioproducts Co., 1986) after a 64-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jun 29, 2005
- Review
- 64 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854312 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854312 Asserachrom IX:AGAmerican Bioproducts Co. · 1986
- This deviceK051054 Visulize Factor IX Antigen KitAffinity Biologicals, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854312 | Asserachrom IX:AG | American Bioproducts Co. | 1986 | — |
| 0 (this device) | K051054 | Visulize Factor IX Antigen Kit | Affinity Biologicals, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K854312 | Asserachrom IX:AGSummary page 1…Subpart H, Hematology Kits and Packages Product Code: GGP Predicate Device: Asserachrom IX:AG, K854312 Diagnostica Stago (formerly American Bioproducts) Device Description: The Vi… | 1986 |
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.
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 IXAntigen Kit is intended for use as an in vitro diagnostic assay for the quantitative determination of Factor IX antigen in human plasma samples and Factor IX concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051054: Visulize Factor IX Antigen Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051054
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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