RANDOX AMIKACIN

K033884 · Randox Laboratories, Ltd. · KLQ · Jun 9, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033884
• Device Name: RANDOX AMIKACIN
• Applicant: Randox Laboratories, Ltd.
• Product Code: KLQ · Clinical Toxicology
• Decision Date: Jun 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3035
• Device Class: Class 2

Intended Use

This test is for the quantitative in vitro determination of amikacin in human serum on automated clinical chemistry analyzers. 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.

Device Story

The Randox Amikacin Test Kit is an in vitro diagnostic reagent for serum analysis. It utilizes a latex-enhanced immunoturbidimetric assay; latex particles coated with amikacin are mixed with an amikacin antibody solution. In the presence of patient serum containing amikacin, the agglutination process is inhibited. The device measures the rate of agglutination via changes in light absorbance; the rate is inversely proportional to the amikacin concentration in the sample. The assay is designed for use on the ADVIA 1650 analyzer. It is operated by laboratory personnel in a clinical setting. Results are used by clinicians to monitor therapeutic drug levels and manage potential overdose, ensuring appropriate patient therapy.

Clinical Evidence

Bench testing only. Method comparison performed on 50 serum samples (patient and spiked) against predicate. Regression analysis: slope 1.10, R-squared 0.99, constant -0.46. Precision evaluated per NCCLS EP5-A; total CVs ranged from 2.4% to 5.5% across three control levels. Analytical sensitivity (LOD) reported as 0.13 ug/mL. Specificity tested against common aminoglycosides (gentamycin, kanamycin, netilmicin, streptomycin, tobramycin) with no significant interference.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay; utilizes latex particles coated with amikacin and an amikacin antibody solution. Designed for use on the ADVIA 1650 analyzer. Measures changes in light absorbance to determine analyte concentration.

Indications for Use

Indicated for the quantitative determination of amikacin in human serum to aid in the diagnosis and treatment of amikacin overdose and to monitor therapeutic levels of amikacin. For use by laboratory personnel.

Regulatory Classification

Identification

An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the top half and "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the bottom half.

JUN - 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories, Ltd. 55 Diamond Road Crumlin, County Antrim United Kingdom BT29 4QY

k033884 Re:

Trade/Device Name: Amikacin Regulation Number: 21 CFR 862.3035 Regulation Name: Amikacin test system Regulatory Class: Class II Product Code: KLQ Dated: April 7, 2004 Received: April 9, 2004

Dear Dr. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that 1157 the statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ maing of substantial equivalence of your device to a legally promatice notification: "Thesults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the presise Evaluation and Safety at [phone]. Also, please note the m vir o Diagnoute Dollywooding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oount oner generers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known) | Unknown K033884 |
|--------------------------|-----------------|
|--------------------------|-----------------|

Amikacin Device Name:

Indications For Use:

Indications For Use.
The Randox Laboratories Limited Amikacin Test Kit is an in vitro diagnostic reagent for The Randox Laboratories Einlitou Annikacin in serum. The method is a latex-enhanced the quantitative determination of anindon in since of measuring changes in scattered
immunoturbidimetric assay based on the principle of measuring of arrikesin Infinunoturbland coated with amikacin, which in the presence of amikacin ilght. Latex particles are oodtod mitte When a sample containing amikacin is introduced antibody Solution, reaction is partially inhibited, slowing down the agglutination process. the agglutination reaction is purchary innished, concentration of amikacin in the The rate of aggrutination is invested in scattered light as a change in absorbance, a sample. Dy monitoning the onange in absorbance in absorbance is inversely concertional to the concentration of amikacin in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of Measurements obtainou by the anonitoring levels of amikacin to ensure appropriate therapy.

This Application Sheet has been developed for the ADVIA® 1650 analyser and must be This Application Oneot has boom or personnel under appropriate laboratory conditions

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Jam Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
K033884

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