510(k) · Cleared

Cleared

Uric Acid

K981766510(k) TraditionalCleared Jun 19, 199831-day reviewClass I21 CFR 862.1775

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

Abbott Laboratories · CDO Acid, Uric, Uricase (U.V.)

Cleared on Jun 19, 1998 as substantially equivalent to K873363 (Boehringer Mannheim Corp., 1987) after a 31-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Jun 19, 1998
Review: 31 days
Class: Class I
Product code: CDO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K873363 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK873363 Uric Acid PapBoehringer Mannheim Corp. · 1987 · Recalled
This deviceK981766 Uric AcidAbbott Laboratories · 1998
Descendant · cites it directly · 0 of its ownK102568 Uric Acid Model 3P39Abbott Laboratories · 2011

Most influential descendants

Showing 1 of 1 · See all

K102568Uric Acid Model 3P39Abbott Laboratories · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K873363	Uric Acid Pap	Boehringer Mannheim Corp.	1987	1
0 (this device)	K981766	Uric Acid	Abbott Laboratories	1998	—
+1	K102568	Uric Acid Model 3P39	Abbott Laboratories	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K981766, 1987–2011Source: 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.

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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
*	K873363	Uric Acid Pap Summary page 2 …98 Page 1 Uric Acidtwp v i E 4 Substantial Eduivalence: H! The Uric Acid assay is substantially equivalent to the Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer for the serum and urine application. These assays yield similar Performance Characteristics. Simi…	Boehringer Mannheim Corp.	1987	1

Also cleared against K873363: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102568	Uric Acid Model 3P39	Abbott Laboratories	2011	0

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.
Of its descendants, K102568 (Abbott Laboratories, 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K873363.

How does its category compare?

All CDO devices

CDO Acid, Uric, Uricase (U.V.): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDO

FDA has decided no CDO device since 2007.

Median 510(k) review, days · CDO

Too few CDO 510(k)s in any year since 2007 to give a median.

Recalls per year · CDO

No recall names CDO since 2007.

Adverse event reports per year · CDO

No MAUDE report names CDO since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. Measurements of uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

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/K981766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981766: Uric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981766

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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