(74 days)
Not Found
No
The description details a standard immunoturbidimetric assay method for measuring gentamicin concentration, which relies on chemical reactions and optical measurements, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is an in vitro diagnostic reagent used to quantify gentamicin levels, which aids in diagnosis and monitoring therapy, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic reagent" and its measurements "are used in the diagnosis and treatment of gentamicin overdose".
No
The device is described as an in vitro diagnostic reagent kit, which includes physical components (reagents, latex particles) and is used with specific hardware analyzers (Hitachi 717 and Advia 1650). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use/Indications for Use: The very first sentence states, "The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent..."
- Explicitly stated in the Device Description: The first sentence of the Device Description also states, "The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent..."
- Performs a test on a biological sample (serum): The device is used for the quantitative determination of gentamicin in serum, which is a biological sample taken from the body.
- Provides information for diagnosis and treatment: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels for appropriate therapy. This is a key characteristic of IVDs.
- Intended for use by qualified laboratory personnel: This indicates it's a test performed in a laboratory setting, which is typical for IVDs.
N/A
Intended Use / Indications for Use
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 quantitative determination of gentamicin based on the principle of measuring changes in scattered light. Immunoglobulin G microparticles are coated with gentamicin and, in the presence of gentamicin antibody latex particles are quickly agglutinated. 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 online in analyzer in scatter on absorbance as a change in absorbance, a concentration curve can be established, from which 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. For professional use. Genuinely qualified laboratory personnel under appropriate laboratory conditions.
Product codes
LCD
Device Description
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 quantitative determination of gentamicin based on the principle of measuring changes in scattered light. Immunoglobulin G microparticles are coated with gentamicin and, in the presence of gentamicin antibody latex particles are quickly agglutinated. 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 online in analyzer in scatter on absorbance as a change in absorbance, a concentration curve can be established, from which the change in absorbance is inversely proportional to the concentration of gentamicin in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For professional use. Genuinely qualified laboratory personnel under appropriate laboratory conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
Page 2 -
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
2
| 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)