510(k) · Cleared
ClearedUrea/Bun, Scal, Nortrol, Abtrol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermofisher Scientific OY · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on May 29, 2008 as substantially equivalent to K991576 (Bayer Corp., 1999) after a 188-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- May 29, 2008
- Review
- 188 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991576 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991576 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- This deviceK073295 Urea/Bun, Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 3 |
| 0 (this device) | K073295 | Urea/Bun, Scal, Nortrol, Abtrol | Thermofisher Scientific OY | 2008 | — |
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? (1)
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 |
|---|---|---|---|
| * | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 3…alent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Urea Nitrogen (UN) assay (K991576). Thermo Fisher Scientific Oy Ratastie 2 +358 (9) 329 100 tel Y-tunnus 0921547-0 www.shermo.coms… | 1999 |
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?
- Its one ancestor has a recall.
- 11 other devices also cite its predicate K991576.
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. 2008, this device’s year, is highlighted.
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 / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy For in vitro diagnostic use for…
Read the full statement (164 words)
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073295: Urea/Bun, Scal, Nortrol, Abtrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073295
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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