510(k) · Cleared

Cleared

Urea Nitrogen2

K203771510(k) TraditionalCleared May 31, 2022524-day reviewClass II21 CFR 862.1770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Ireland Diagnostics Division · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

Cleared on May 31, 2022 as substantially equivalent to K981918 (Abbott Laboratories, 1998) after a 524-day review. Its family tree reaches back 2 generations to 1977.

Decided: May 31, 2022
Review: 524 days
Class: Class II
Product code: CDQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K771923 (1977). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK771923 Fastchem BunBoehringer Mannheim Corp. · 1977
1 generation backK981918 UREAAbbott Laboratories · 1998 · Recalled
This deviceK203771 Urea Nitrogen2Abbott Ireland Diagnostics Division · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K771923	Fastchem Bun	Boehringer Mannheim Corp.	1977	—
−1	K981918	UREA	Abbott Laboratories	1998	1
0 (this device)	K203771	Urea Nitrogen2	Abbott Ireland Diagnostics Division	2022	—

FIG. 1 — Lineage of K203771, 1977–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K981918	UREA Summary page 5 …n Name: Urease and Glutamic Dehydrogenase, Urea Nitrogen Governing Regulation Number: 21 CFR 862.1770 Product Code: CDQ IV. Predicate Device Urea Nitrogen (k981918) V. Description of Device A. Principles of the Procedure The Urea Nitrogen2 assay is an automated clinical chemist…	Abbott Laboratories	1998	1

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?

The line of descent spans 45 years and passes through 3 companies; a new generation was cleared every 23.8 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All CDQ devices

CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · CDQ

1in 2022

2007high 1 (2007) · low 0 (2009)2026

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

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CDQ

6in 2025

2007high 231 (2016) · low 0 (2007)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 Nitrogen2 assay is used for the quantitation of Urea Nitrogen in human serum, plasma, or urine on the

ARCHITECT c System.

The Urea Nitrogen2 assay is to used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K203771 · printed Nov 4, 2026

Cite this page

510(k) Report. “K203771: Urea Nitrogen2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203771

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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