510(k) · Cleared
ClearedRoche Reagent for Bun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Oct 25, 1995 after a 61-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 25, 1995
- Review
- 61 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK954000 Roche Reagent for BunRoche Diagnostic Systems, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK183555 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- Descendant · cites it directly · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
- Descendant · cites it directly · 0 of its ownK103615 Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine…Alfa Wassermann Diagnostic Technologies, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019 · cites it directly1descendant
- K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · cites it directly1descendant
- K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023 · 2 generations on0descendants
- K103615Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…Alfa Wassermann Diagnostic Technologies, Inc. · 2011 · cites it directly0descendants
- K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954000 | Roche Reagent for Bun | Roche Diagnostic Systems, Inc. | 1995 | — |
| +1 | K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| +1 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
| +2 | K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023 | — |
| +1 | K103615 | Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent… | Alfa Wassermann Diagnostic Technologies, Inc. | 2011 | 1 |
| +2 | K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents | Seppim S.A.S. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 CDQ? 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 CDQ device
- #1 K203771 Urea Nitrogen2score 3.7 · 2 generations · no Class I recall
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? (6)
4 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, K183555 (Instrumentation Laboratory CO, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CDQ devicesCDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · CDQ
Too few CDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CDQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDQ
6in 2025
MAUDE reports naming product code CDQ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 1 | 37 |
| 2012 | 0 | — | 0 | 44 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 231 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954000: Roche Reagent for Bun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954000
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026