510(k) · Cleared

Cleared

Randox Amikacin

K033884510(k) TraditionalCleared Jun 9, 2004177-day reviewClass II21 CFR 862.3035

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Randox Laboratories, Ltd. · KLQ Radioimmunoassay, Amikacin

Cleared on Jun 9, 2004 after a 177-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Jun 9, 2004
Review: 177 days
Class: Class II
Product code: KLQ
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K033884Source: 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.

Planning a device in KLQ? 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

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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 KLQ devices

KLQ Radioimmunoassay, Amikacin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLQ

FDA has decided no KLQ device since 2007.

Median 510(k) review, days · KLQ

Too few KLQ 510(k)s in any year since 2007 to give a median.

Recalls per year · KLQ

No recall names KLQ since 2007.

Adverse event reports per year · KLQ

1in 2025

2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code KLQ, not matched to any one device; reports are not rates.

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	—	3
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	1
2022	—	0
2023	—	1
2024	—	0
2025	—	1
2026	—	—

What is it indicated for?

Read the full statement (172 words)

The Randox Laboratories Limited Amikacin Test Kit is an in vitro diagnostic reagent for the quantitative determination of amikacin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with amikacin, which in the presence of amikacin antibody solution, rapidly agglutinate. When a sample containing amikacin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of amikacin in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of amikacin in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of amikacin use or overdose and in monitoring levels of amikacin to ensure appropriate therapy.

This Application Sheet has been developed for the ADVIA® 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions

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

https://510kreport.com/device/K033884 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033884: Randox Amikacin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033884

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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