510(k) · Cleared
ClearedCoamate Protein C Chromogenic Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chromogenix AB · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Dec 7, 1992 after a 210-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 7, 1992
- Review
- 210 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK922201 Coamate Protein C Chromogenic AssayChromogenix AB · 1992
- Descendant · cites it directly · 1 of its ownK023990 Chromocheck Protein C 25; Chromocheck Protein C 50Precision Biologic · 2003
- Descendant · cites it directly · 1 of its ownK980875 IL Test Protein CInstrumentation Laboratory CO · 1998
- Descendant · 2 generations on · 0 of its ownK062430 Hemosil Protein CInstrumentation Laboratory CO · 2006
- Descendant · cites it directly · 0 of its ownK050365 Biophen Protein C5, C2.5, Models 221205, 221202Hyphen Biomed · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK050448 Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx · 2005
Most influential descendants
Showing 5 of 5 · See all- K023990Chromocheck Protein C 25; Chromocheck Protein C 50Precision Biologic · 2003 · cites it directly1descendant
- K980875IL Test Protein CInstrumentation Laboratory CO · 1998 · cites it directly1descendant
- K062430Hemosil Protein CInstrumentation Laboratory CO · 2006 · 2 generations on0descendants
- K050365Biophen Protein C5, C2.5, Models 221205, 221202Hyphen Biomed · 2005 · cites it directly0descendants
- K050448Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922201 | Coamate Protein C Chromogenic Assay | Chromogenix AB | 1992 | — |
| +1 | K023990 | Chromocheck Protein C 25; Chromocheck Protein C 50 | Precision Biologic | 2003 | — |
| +1 | K980875 | IL Test Protein C | Instrumentation Laboratory CO | 1998 | — |
| +2 | K062430 | Hemosil Protein C | Instrumentation Laboratory CO | 2006 | — |
| +1 | K050365 | Biophen Protein C5, C2.5, Models 221205, 221202 | Hyphen Biomed | 2005 | 1 |
| +2 | K050448 | Chromopep PC, Chromopep at, Models 2.5 and 5 | Horiba Abx | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K023990 (Precision Biologic, 2003) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K922201 · printed Nov 4, 2026
Cite this page
510(k) Report. “K922201: Coamate Protein C Chromogenic Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K922201
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026