510(k) · Cleared
ClearedUrea Nitrogen (Bun) Liquid Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jas Diagnostic, Inc. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Jul 17, 2001 after a 54-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jul 17, 2001
- Review
- 54 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011596 Urea Nitrogen (Bun) Liquid ReagentJas Diagnostic, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK070704 Trilogy AnalyzerDrew Scientific, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070704Trilogy AnalyzerDrew Scientific, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011596 | Urea Nitrogen (Bun) Liquid Reagent | Jas Diagnostic, Inc. | 2001 | — |
| +1 | K070704 | Trilogy Analyzer | Drew Scientific, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | — | Roche Diagnostics BUN (Urea Nitrogen) Reagent for the Cobas Mira analyzers Named without a submission number | |
| * | — | Pointe Scientific Urea Nitrogen (BUN) Reagent (generic) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070704 | Trilogy Analyzer | 2007 | 0 |
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, K070704 (Drew Scientific, Inc., 2007) has gone furthest, with 0 descendants 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 | — |
What is it indicated for?
Intended for the In Vitro, guantitative determination of urea nitrogen (BUN) in human serum on automated chemistry analyzers.
Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011596: Urea Nitrogen (Bun) Liquid Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011596
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026