510(k) · Cleared
ClearedAtac Pak Bun Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elan Diagnostics · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Jul 12, 2002 after a 71-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 12, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | HiChem BUN Reagent Kit, product no. 88806 Named without a submission number |
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.
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 ATAC PAK BUN Reagent Kit is intended for use with the ATAC 6000 Random Access Chemistry System for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021385: Atac Pak Bun Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021385
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026