(32 days)
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No
The summary describes laboratory control materials for therapeutic drug monitoring, which are chemical reagents, not software or hardware that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as controls for accuracy and precision in clinical chemistry, intended for use in therapeutic drug monitoring, not as a device that provides therapy itself.
No
Explanation: This device, the Randox Laboratories Limited Drug Controls, is intended for "control of accuracy and precision in clinical chemistry" and "for use in therapeutic drug monitoring." It is a control material used to assess the performance of diagnostic tests, not to diagnose a condition itself.
No
The device description clearly states it is based on lyophilized human serum, which is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are for "the control of accuracy and precision in clinical chemistry" and "intended for use in therapeutic drug monitoring." These activities are performed on samples taken from the human body (human serum) to provide information about a patient's health status or to monitor treatment.
- Device Description: The device is based on "Ivophilised human serum," which is a biological sample derived from humans.
- Anatomical Site: The anatomical site is "human serum," which is a sample taken from the human body.
These characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on Ivophilised The Handox Laboratories Linked Drug Cruit of Loth accuracy and precision in human serum and have been developed for the control drug monitoring. These control officul chomistry, at three constituent concentrations. The Randox Human Drug Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
DIF
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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines forming the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 4 2001
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K012319
Trade/Device Name: Human Drug Controls Levels I, II and III Regulation Number: 21 CFR 862.3280 Regulatory Class: I, reserved Product Code: DIF Dated: July 11, 2001 Received: July 23, 2001
Dear Dr. Armstrong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 Sutman
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) Kol2319
HUMAN DRUG CONTROLS Device Name
LEVELS I, II and III
Indications For Use :
The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on Ivophilised The Handox Laboratories Linked Drug Cruit of Loth accuracy and precision in human serum and have been developed for the control drug monitoring. These control officul chomistry, at three constituent concentrations.
The Randox Human Drug Controls should only 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)
Kesia Alexander Archer Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012319
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format1-2-96)