510(k) · Cleared
Recalled · Class II · 2023Biophen Protein C5, C2.5, Models 221205, 221202
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyphen Biomed · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Dec 27, 2005 as substantially equivalent to K922201 (Chromogenix AB, 1992) after a 316-day review. Its family tree reaches back 1 generation to 1992. It has been recalled once.
- Decided
- Dec 27, 2005
- Review
- 316 days
- Class
- Class II
- Product code
- GGP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922201 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK922201 Coamate Protein C Chromogenic AssayChromogenix AB · 1992
- This deviceK050365 Biophen Protein C5, C2.5, Models 221205, 221202Hyphen Biomed · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922201 | Coamate Protein C Chromogenic Assay | Chromogenix AB | 1992 | — |
| 0 (this device) | K050365 | Biophen Protein C5, C2.5, Models 221205, 221202 | Hyphen Biomed | 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 |
|---|---|---|---|
| * | K922201 | Coamate Protein C Chromogenic AssaySummary page 1…0.84 10 1.51 12 Comments on substantial equivalence: Biophen Protein C is substantially equivalent to Coamnatic Protein C (K922201). manufactured by Chromogenix AB, and currently marketed in the United states by Instrumentation laboratory; this is based on the… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2023 | Class II | Z-1227-2023 | Other | New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K922201.
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?
Biophen Protein C 5 &2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050365: Biophen Protein C5, C2.5, Models 221205, 221202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050365
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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