510(k) · Cleared

Cleared

Randox Uric Acid

K033278510(k) TraditionalCleared Feb 27, 2004140-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

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

Cleared on Feb 27, 2004 after a 140-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Feb 27, 2004
Review: 140 days
Class: Class I
Product code: CDO
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K033278Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 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 Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is non-absorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is…

Read the full statement (144 words)

Uric acid measurements 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.

This application sheet has been developed for the Dade Dimension Clinical Chemistry Analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K033278 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033278: Randox 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/K033278

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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