(225 days)
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No
The description details a standard immunoturbidimetric assay based on chemical reactions and light measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic reagent used for the quantitative determination of theophylline in serum, which aids in diagnosis and monitoring, not direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose."
No
The device is an in vitro diagnostic reagent kit, which is a physical product containing chemical components (latex particles, antibody solution) used in a laboratory setting. 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 clearly states, "The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum."
- Explicitly stated in the Device Description: The first sentence of the Device Description also states, "The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum."
- Analyzes a sample from the human body: The device determines theophylline in "serum," which is a component of blood, a sample taken from the human body.
- Used for diagnosis and treatment: The Intended Use states that the measurements are used "in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy." This directly aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or treatment.
- Performed outside the body: The method described is a laboratory test performed on a serum sample, not directly on or in the patient's body.
All these points confirm that the Randox Laboratories Ltd. Theophylline Test Kit fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline 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 theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy.
This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
KLS
Device Description
The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline 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 theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline 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
used by suitably qualified laboratory 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3880 Theophylline test system.
(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of a bird.
JAN 1 7 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Heather Anderson Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road, Crumlin, Co Antrim United Kingdom BT29 4QY
K011771 Re:
Trade/Device Name: Theophylline Regulation Number: 21 CFR 862.3880 Regulation Name: Theophylline test system Regulatory Class: Class II Product Code: KLS Dated: December 17, 2001 Received: December 20, 2001
Dear Dr. Anderson:
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 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 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 Gutman
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): | Not Known K011771 |
|---|---|
| Device Name: | THEOPHYLLINE |
Indications For Use :
The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline 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 theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy.
This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably 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 | K011771 |
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)