510(k) · Cleared
ClearedUric Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CDO Acid, Uric, Uricase (U.V.)
Cleared on May 7, 1998 as substantially equivalent to K922762 (Roche Diagnostic Systems, Inc., 1992) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 7, 1998
- Review
- 35 days
- Class
- Class I
- Product code
- CDO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873363 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK873363 Uric Acid PapBoehringer Mannheim Corp. · 1987 · Recalled
- This deviceK981189 Uric AcidAbbott Laboratories · 1998
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) | K981189 | Uric Acid | Abbott Laboratories | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 CDO? 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
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 |
|---|---|---|---|
| * | K922762 | Roche Reagent for Uric Acid--ModificationSummary page 2…@o10 Substantial Equivalence: The Uric Acid assay is substantially equivalent to the following devices: - Roche® Cobas Mira® Plus Automated Chemistry Uric Acid assay (K922762) for the serum application - Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer for the urine applica… | 1992 |
| * | K873363 | Uric Acid PapSummary page 2…nt to the following devices: - Roche® Cobas Mira® Plus Automated Chemistry Uric Acid assay (K922762) for the serum application - Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer for the urine application These assays yield similar Performance Characteristics. Similarities t… | 1987 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K922762.
How does its category compare?
All CDO devicesCDO 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. 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/K981189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981189: 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/K981189
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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