(111 days)
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No
The document describes a laboratory control material for cardiac monitoring, which is a chemical reagent used for quality control, not a device that processes data or images using AI/ML.
No
The device is described as a control material for clinical chemistry applications, specifically for monitoring accuracy and precision in cardiac monitoring, not for treating any medical condition.
No
Explanation: This device is a control material used to assess the accuracy and precision of clinical chemistry applications, specifically cardiac monitoring. It is not used to diagnose a patient but rather to validate the performance of diagnostic tests.
No
The device description explicitly states it is based on "lyophilized human serum" and is a "control material," indicating a physical substance, not software.
Based on the provided information, the Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring." This indicates it's used to evaluate the performance of diagnostic tests performed in vitro (outside the body) on biological samples (human serum).
- Device Description: The description confirms it's based on lyophilized human serum and used in clinical chemistry applications.
- Function: Control materials like this are essential for ensuring the reliability and accuracy of diagnostic tests. They are used to verify that the test system is working correctly.
IVD devices are products used to examine specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. Control materials fall under this category as they are used to validate the performance of the diagnostic tests themselves.
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Intended Use / Indications for Use
The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.
The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
JJY
Device Description
The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.
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
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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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 9 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K041361
Trade/Device Name: Tri- Level Cardiac Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 31, 2004 Received: September 2, 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 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 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, DVM.
Tean 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)
Device Name: Tri-Level Cardiac Control
Indications For Use:
The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.
The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory 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)
Carol Benson
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041361