510(k) · Cleared
ClearedUREA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trace Scientific, Ltd. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Apr 24, 1998 as substantially equivalent to K954000 (Roche Diagnostic Systems, Inc., 1995) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Apr 24, 1998
- Review
- 28 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K771923 (1977). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK771923 Fastchem BunBoehringer Mannheim Corp. · 1977
- This deviceK981123 UREATrace Scientific, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771923 | Fastchem Bun | Boehringer Mannheim Corp. | 1977 | — |
| 0 (this device) | K981123 | UREA | Trace Scientific, Ltd. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K954000 | Roche Reagent for BunSummary page 2…ogen 510(k) Section Il March 26, 1998 Page 1 BUNKfinal lwp 00560012 ,,,,,,,, .. Roche® Cobas Mira®Plus Automated Chemistry System Urea Nitrogen assay (K954000) for the serum application . Boehringer Mannheim® Urea Nitrogen assay on the Hitachi® 717 Analyzer (K771923) for the urine appli… | 1995 |
| * | K771923 | Fastchem BunSummary page 2…s Mira®Plus Automated Chemistry System Urea Nitrogen assay (K954000) for the serum application . Boehringer Mannheim® Urea Nitrogen assay on the Hitachi® 717 Analyzer (K771923) for the urine application These assays yield similar Performance Characteristics. Similarities to Roche: . Both assays are in v… | 1977 |
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.
- 3 other devices also cite its predicate K954000.
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?
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in 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/K981123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981123: UREA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981123
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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