510(k) · Cleared
ClearedUric Acid Model 3P39
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KNK Acid, Uric, Uricase (Colorimetric)
Cleared on May 6, 2011 as substantially equivalent to K981766 (Abbott Laboratories, 1998) after a 241-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- May 6, 2011
- Review
- 241 days
- Class
- Class I
- Product code
- KNK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873363 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K981766 | Uric AcidSummary page 1…vice Classification: Class I Classification Panel: Clinical Chemistry Product Code: KNK Legally marketed device to which equivalency is claimed: Abbott Uric Acid Assay (K98 1766) Intended Use of Device: The Architect Uric Acid assay is used for the quantitation of uric acid in human serum, plasma, or uri… | 1998 |
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 24 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All KNK devicesKNK Acid, Uric, Uricase (Colorimetric): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 ARCHITECT Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device 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 as stated in the FDA summary.
https://510kreport.com/device/K102568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102568: Uric Acid Model 3P39.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102568
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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