RANDOX GENTAMICIN

K012978 · Randox Laboratories, Ltd. · LCD · Sep 18, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012978
• Device Name: RANDOX GENTAMICIN
• Applicant: Randox Laboratories, Ltd.
• Product Code: LCD · Clinical Toxicology
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the determination of gentamicin in serum. The method is a latex-enhanced quantitative determination of gentamicin by the principle of measuring changes in scattered light. Immunoturbidimetric assay with gentamicin and, in the presence of gentamicin antibody, latex particles are coated with gentamicin. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in absorbance, a concentration curve can be established; the change in absorbance is inversely proportional to the concentration of gentamicin in the sample. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers. To be used by qualified laboratory personnel under appropriate laboratory conditions.

Device Story

In vitro diagnostic reagent kit for quantitative measurement of gentamicin in serum; utilizes latex-enhanced immunoturbidimetric assay principle. Input: patient serum sample. Mechanism: gentamicin in sample competes with gentamicin-coated latex particles for antibody binding sites; agglutination reaction inhibited by presence of sample gentamicin; rate of agglutination inversely proportional to gentamicin concentration. Output: change in absorbance measured by clinical chemistry analyzers (Hitachi 717, Advia 1650). Used in clinical laboratories by qualified personnel. Results used by clinicians to manage gentamicin dosing, ensure therapeutic efficacy, and detect potential overdose.

Clinical Evidence

No clinical data provided; device performance is based on analytical bench testing of the immunoturbidimetric assay.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay; utilizes light scattering/absorbance measurement. Designed for use on automated clinical chemistry analyzers (Hitachi 717, Advia 1650). Reagent-based system.

Indications for Use

Indicated for the quantitative determination of gentamicin in human serum to assist in the diagnosis and treatment of gentamicin overdose and to monitor therapeutic drug levels. For use by qualified laboratory personnel in clinical laboratory settings.

Regulatory Classification

Identification

A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY

k012978 Re:

Trade/Device Name: Gentamicin Regulation Number: 21 CFR 862.3450 Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD Dated: July 4, 2001 Received: July 6, 2001

## 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 for associous 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). and coosmeter rev (110) and 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.

SEP 1 8 2001

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed t predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K012978 |
|---------------------------|------------|
| Device Name: | GENTAMICIN |

## Indications For Use :

The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the The Handox Edboration of gentamicin in serum. The method is a latex-enhanced quantitulive dolormination of agentian the principle of measuring changes in scattered light. Inimunoluluinematic assess with gentamicin and, in the presence of gentamicin antibody Eatex partions are ookly will great. When a sample containing gentamicin is introduced the soldination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By aggiturialion in Inversory dopenastic that as a change in absorbance, a concentration curve can monitoring the online in beatler on absorbance is inversely proportional to the concentration of gentamicin in the sample.

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

These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers Thou Appliodiler. Groutebly qualified laboratory personnel under appropriate laboratory conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K012978 |
|---------------|---------|
|---------------|---------|

Prescription Use _V (Per 21 CFR 801.109)

OR

Over-The-Counter Use_ (Optional format 1-2-96)