(29 days)
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No
The document describes laboratory controls for a CRP assay, which are chemical reagents used for quality control, not a device that processes data or makes decisions using AI/ML.
No
Explanation: The device is described as controls for C-Reactive Protein (CRP) assays, used to check the accuracy and precision of laboratory tests, not to treat a medical condition.
No
Explanation: The device is described as a control material for C-Reactive Protein (CRP) assays, used for "control of both accuracy and precision in CRP assays." It does not directly diagnose a patient's condition but rather helps ensure the proper functioning of diagnostic CRP assays.
No
The device is described as liquid controls containing human recombinant CRP in a stabilised protein matrix, which are physical substances, not software.
Based on the provided information, the Randox Laboratories Ltd. C-Reactive Protein Controls are an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states they are "for use in the control of both accuracy and precision in CRP assays." CRP assays are laboratory tests performed on biological samples (in vitro) to diagnose or monitor medical conditions.
- Device Description: The description confirms they are "liquid controls containing human recombinant CRP in a stabilised protein matrix," which are materials used to verify the performance of in vitro diagnostic tests.
- Intended User/Care Setting: The intended users are "suitably qualified laboratory personnel under appropriate laboratory conditions," which is typical for IVD devices used in clinical laboratories.
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 Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations.
The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
JJX
Device Description
Liquid controls containing human recombinant CRP in a stabilised protein matrix.
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)
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 2 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
K040351 Re:
Trade/Device Name: Liquid C-Reactive Protein Controls (Levels II and III) Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class I Product Code: JJX Dated: January 29, 2004 Received: February 12, 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 vours.
Jean M. Cooper, MS, DVM.
Yean 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
2
510(k) Number (if known) NOT KNOWN KOYO351
LIQUID C-REACTIVE PROTEIN CONTROLS (LEVELS II AND III) Device Name:
Indications For Use :
The Randox Laboratories Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations.
The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
Division Sign-Off
vision Sian-
Office of In Vitro Diagno Device Evaiuation an 510(k)
ver-The-Counter Use
(Optional format 1-2-96)