510(k) · Cleared
ClearedIL Test Urea Nitrogen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Dec 17, 1997 as substantially equivalent to K932467 (Instrumentation Laboratory CO, 1993) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 17, 1997
- Review
- 29 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932467 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932467 Ilab 900/1800 Clinical Chemistry SystemInstrumentation Laboratory CO · 1993
- This deviceK974337 IL Test Urea NitrogenInstrumentation Laboratory CO · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932467 | Ilab 900/1800 Clinical Chemistry System | Instrumentation Laboratory CO | 1993 | — |
| 0 (this device) | K974337 | IL Test Urea Nitrogen | Instrumentation Laboratory CO | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K932467 | Ilab 900/1800 Clinical Chemistry SystemSummary page 1…ification name(s): 862.1770 Urea Nitrogen test systems Class II 75CDN Urease, Photometric, Urea Nitrogen Identification of predicate device(s): IL Test™ Urea Nitrogen K932467 K943595 — Serum and Urine Claims Added Description of the device/intended use(s): IL Test™ Urea Nitrogen is an in vitro diagnos… | 1993 |
| * | K943595 | Serum/Urine Appli Ilab (TM) Clinical Chemistry SystemSummary page 1…n name(s): 862.1770 Urea Nitrogen test systems Class II 75CDN Urease, Photometric, Urea Nitrogen Identification of predicate device(s): IL Test™ Urea Nitrogen K932467 K943595 — Serum and Urine Claims Added Description of the device/intended use(s): IL Test™ Urea Nitrogen is an in vitro diagnostic test… | 1994 |
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 K932467.
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?
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory’s line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology. Increases in serum urea nitrogen (urea) can be a result of kidney dysfunction or urinary tract obstruction'.
'Friedman, R. et al., Effects of Diseases on Clinical Laboratory Tests, Clin. Chem., 26: (4), 1980
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/K974337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974337: IL Test Urea Nitrogen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974337
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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