(231 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 to quantify carbamazepine in serum for diagnosis and monitoring, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states, "Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine use or overdose and in monitoring levels of carbamazepine to ensure appropriate therapy." This explicitly indicates a diagnostic purpose.
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 with specific hardware analysers (Hitachi 717, 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 clearly states, "The Randox Laboratories Ltd. Carbamazepine 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. Carbamazepine Test Kit is an in vitro diagnostic reagent..."
- Purpose of the device: The device is designed to analyze a sample (serum) taken from the human body to provide information for the diagnosis and treatment of a medical condition (carbamazepine use or overdose and monitoring therapy). This is the core function of an IVD.
- Method of analysis: The method described (latex-enhanced immunoturbidimetric assay) is a common technique used in IVD testing.
- Intended User/Care Setting: The device is intended for use by "suitably qualified laboratory personnel under appropriate laboratory conditions," which is typical for IVD devices used in clinical laboratories.
N/A
Intended Use / Indications for Use
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine 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 carbamazepine which, in the presence of carbamazepine eatibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agaly tination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine 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 carbamazepine in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine use or overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
KLT
Device Description
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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
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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§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines emanating from the head, representing health, knowledge, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure. The logo is black and white.
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
JAN 1 5 2002
K011648 Re:
Trade/Device Name: Carbamazepine Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: KLT 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 we nave roviewed your becament ind 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). and Cosmotion Free (110) that be device, subject to the general controls provisions of the Act. The I ou may ; ateres, mains of the Act include requirements for annual registration, listing of general controls profitering 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 If your device is elassince (toonal 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 r load be act note a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must of any I odolul statutes and stiments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (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 I his letter will and w you so organ substantial equivalence of your device to a legally marketed noutication. The I Dr I mailing of sassification 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 If you desire spoolite actives jiagnostic devices), please contact the Office of Compliance at additionally 607.10 for milestions on the promotion and advertising of your device, (201) 594-4565. Traditional (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 Information on Jour respect 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,
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): | Not Known K011648 |
|---|---|
| --------------------------- | ------------------- |
Device Name:
CARBAMAZEPINE
Indications For Use :
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine 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 carbamazepine which, in the presence of carbamazepine eatibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agaly tination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine 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 carbamazepine in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine use or overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers 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)
| Lan Cooper | |
|---|---|
| (Division Sigr-Off) | |
| Division of Coral Laboratory Devices | |
| 510(k) Numbe | KC11648 |
Image /page/2/Picture/10 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" on the next line. There is a large "X" that is drawn over the text. The text is likely related to medical or pharmaceutical information.
OR
Over-The-Counter Use (Optional format 1-2-96)