510(k) · Cleared
ClearedCareside Uric Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careside, Inc. · KNK Acid, Uric, Uricase (Colorimetric)
Cleared on Jun 25, 1998 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 58-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 25, 1998
- Review
- 58 days
- Class
- Class I
- Product code
- KNK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
- This deviceK981604 Careside Uric AcidCareside, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912844 | Kodak Ektachem Dtii System | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K981604 | Careside Uric Acid | Careside, Inc. | 1998 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 1…the Vitros DT 60 IL Johnson and Johnson’s (formerly Eastman Kodak, Inc.) Vitros URIC Slides for Johnson and Johnson’s Vitros DT 60 (formerly Eastman Kodak’s DT 60 II). K912844/A 75JHB Name of Predicate Device: Predicate Device 510K number: Product Code: CARESIDE, Inc. CARESIDE™ Uric Aci… | 1991 |
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?
- Its one ancestor has no recall.
- 28 other devices also cite its predicate K912844.
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?
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure uric acid from whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with numerous renal and metabolic disorders including renal failure, gout, leukemia, psoriasis, starvation or wasting conditions, and of patients receiving cytotoxic drugs. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
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/K981604 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981604: Careside Uric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981604
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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