(177 days)
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No
The description details a standard immunoturbidimetric assay based on chemical reactions and light scattering, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic reagent used to measure amikacin levels in serum, which aids in monitoring drug therapy. It does not directly treat or diagnose a disease.
Yes
The device is described as an "in vitro diagnostic reagent for the quantitative determination of amikacin in serum" and its measurements are "used in the diagnosis and treatment of patients".
No
The device is an in vitro diagnostic reagent kit that performs a chemical assay. It is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is an "in vitro diagnostic reagent for the quantitative determination of amikacin in serum." It also mentions that the measurements are used "in the diagnosis and treatment of patients."
- Device Description: The description details a laboratory test performed on a biological sample (serum) to measure a substance (amikacin) within that sample. This is a hallmark of an in vitro diagnostic device.
- Intended User / Care Setting: The mention of "trained personnel under appropriate laboratory conditions" further reinforces that this is a device used in a clinical laboratory setting for diagnostic purposes.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, from the human body to help diagnose diseases or conditions. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
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, reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely proportional to the concentration of amikacin in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of patients by monitoring levels of amikacin to ensure appropriate therapy.
This Application Sheet has been developed for the ADVIA® 1650 analyser and must be performed by or personnel under appropriate laboratory conditions.
Product codes
KLQ
Device Description
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, reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely proportional to the concentration of amikacin in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Performed by or personnel under appropriate laboratory conditions.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3035 Amikacin test system.
(a)
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.(b)
Classification. Class II.
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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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