510(k) · Cleared
ClearedParagon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JKM Immunochemical, Bence-Jones Protein
Cleared on May 6, 2005 as substantially equivalent to K802592 (Beckman Instruments, Inc., 1980) and 1 other predicate after a 108-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- May 6, 2005
- Review
- 108 days
- Class
- Class II
- Product code
- JKM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802592 (1980). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK802592 Paragon Serum Protein ElectrophoresisBeckman Instruments, Inc. · 1980
- This deviceK050119 Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine…Beckman Coulter, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802592 | Paragon Serum Protein Electrophoresis | Beckman Instruments, Inc. | 1980 | — |
| 0 (this device) | K050119 | Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by… | Beckman Coulter, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 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 JKM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K802592 | Paragon Serum Protein ElectrophoresisSummary page 2…facturer Docket Number PARAGON CZE PARAGON SPE Kit Beckman K802592 2000 UPE Kit Coulter, Inc. PARAGON CZE PARAGON IFE Kit Beck… | 1980 |
| * | K823884 | Paragon Immunoelectrophoresis ReagentSummary page 2…Beckman K802592 2000 UPE Kit Coulter, Inc. PARAGON CZE PARAGON IFE Kit Beckman K823884 2000 U-IFE/s Kit Coulter, Inc. 5.0 Description: The PARAGON CZE® 2000 UPE and U-… | 1983 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K802592.
How does its category compare?
All JKM devicesJKM Immunochemical, Bence-Jones Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · JKM
Too few JKM 510(k)s in any year since 2007 to give a median.
Recalls per year · JKM
No recall names JKM since 2007.
Adverse event reports per year · JKM
No MAUDE report names JKM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended
for use with the Paragon CZE 2000 Capillary Electrophoresis System for the
electrophoretic separation of proteins in human urine.
The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s)
Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary
Electrophoresis System for the immunologic identification of monoclonal
components in human urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050119 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050119: Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050119
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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