510(k) · Cleared
ClearedSigma Diagnostics Infinity Bun Reagent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Aug 5, 1998 as substantially equivalent to K971477 (Trace America, Inc., 1997) after a 41-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 5, 1998
- Review
- 41 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971477 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971477 Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization…Trace America, Inc. · 1997
- This deviceK982236 Sigma Diagnostics Infinity Bun Reagent KitSigma Diagnostics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST) | Trace America, Inc. | 1997 | — |
| 0 (this device) | K982236 | Sigma Diagnostics Infinity Bun Reagent Kit | Sigma Diagnostics, Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)Summary page 1…iagnostics INFINITY™ BUN Reagent (Procedure No. 63) is substantially equivalent to, and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477. References 1. Tietz Textbook of Clinical Chemistry. Burtis CA and Ashwood ER (Eds). Second Edition. WB Saunders Company, 1994 2… | 1997 |
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 no recall.
- 2 other devices also cite its predicate K971477.
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 Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea
nitrogen (an end product of nitrogen metabolism) in serum. Measurements obtained by
the 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/K982236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982236: Sigma Diagnostics Infinity Bun Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982236
Report an extraction error
Are you the manufacturer?
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