(74 days)
The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. 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 scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or 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 and are for use by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. 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 scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.
The provided text is related to a 510(k) premarket notification for a Gentamicin Test Kit. It includes the FDA's letter of substantial equivalence and the indications for use. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided document.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 862.3450 Gentamicin test system.
(a)
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.(b)
Classification. Class II.