510(k) · Cleared
ClearedUric Acid Assay for the Advia Integrated Modular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · KNK Acid, Uric, Uricase (Colorimetric)
Cleared on Mar 18, 2003 after a 264-day review. The FDA summary names no predicate by number.
- Decided
- Mar 18, 2003
- Review
- 264 days
- Class
- Class I
- Product code
- KNK
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 KNK? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All KNK devicesKNK Acid, Uric, Uricase (Colorimetric): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNK
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KNK
Too few KNK 510(k)s in any year since 2007 to give a median.
Recalls per year · KNK
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNK
2in 2025
MAUDE reports naming product code KNK, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 2 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 2 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Buyer ADVIA IMS Uric Acid (UA) method is an in vifro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022096: Uric Acid Assay for the Advia Integrated Modular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022096
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026