510(k) · Cleared
ClearedChromopep PC, Chromopep at, Models 2.5 and 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Sep 23, 2005 as substantially equivalent to K023990 (Precision Biologic, 2003) and 1 other predicate after a 213-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Sep 23, 2005
- Review
- 213 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915083 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- 3 generations backK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- 2 generations backK022195 Coamatic at-400Instrumentation Laboratory CO · 2002
- 1 generation backK023991 Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Precision Biologic · 2003
- This deviceK050448 Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915083 | Coamate (R) Antithrombin Chromogenic Assay | Kabi Pharmacia, Inc. | 1992 | — |
| −3 | K980499 | IL Test Antithrombin | Instrumentation Laboratory CO | 1998 | — |
| −2 | K022195 | Coamatic at-400 | Instrumentation Laboratory CO | 2002 | — |
| −1 | K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 | Precision Biologic | 2003 | — |
| 0 (this device) | K050448 | Chromopep PC, Chromopep at, Models 2.5 and 5 | Horiba Abx | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K023990 | Chromocheck Protein C 25; Chromocheck Protein C 50Summary page 3…Predicate device: Device: Device Name Chromocheck Protein C Chromopep PC (K023990) Intended Use Test, quantitative factor deficiency Test, Quantitative factor deficiency Analytes Protein… | 2003 |
| * | K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Summary page 2…C of Precision BioLogic (KO23990). Chromopep AT The Chromopep AT is substantially equivalent to the predicate device Chromocheck Antithrombin AT of Precision BioLogic (K023991). Description: Chromopep PC is a chromogenic assay consisting of a synthetic substrate and Protein C activator. Chromopep AT… | 2003 |
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 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 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?
CHROMOPEP AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
CHROMOPEP PC is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050448: Chromopep PC, Chromopep at, Models 2.5 and 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050448
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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