(76 days)
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No
The description details a standard enzymatic assay for potassium, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic reagent used to determine potassium levels, which aids in the diagnosis and treatment of conditions, but it does not directly provide therapy.
Yes
The text explicitly states, "The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent," and "Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions."
No
The device is an in vitro diagnostic reagent kit, which is a chemical substance used in laboratory tests, not a software-only medical device. It is used with specific hardware analyzers.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Potassium in serum."
- "Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use..."
These statements clearly indicate that the device is intended for use outside of the body to diagnose or monitor disease conditions.
N/A
Intended Use / Indications for Use
The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Potassium in serum. Potassium is determined enzymatically via Potassium dependant pyruvate kinase activity using phosphoenolpyruvate as substrate. The pyruvate formed reacts with NADH in the presence of LDH to form lactate and NAD. The corresponding decrease in absorbance at 340 nm is proportional to the potassium concentration.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Potassium kit.
The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Product codes
CEJ, JIT
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
suitable 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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§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
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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 the department's name arranged in a circular fashion around a stylized emblem. The emblem depicts an abstract representation of an eagle or bird, with three curved lines forming its body and wings. The overall design is simple and recognizable, representing the department's role in public health and human services.
FEB 1 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY
K043267 Re:
Trade/Device Name: Potassium Test Kit and Electrolyte Cal 1 and 2 Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEJ, JIT Dated: October 29, 2004 Received: November 26, 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, de Hees mat hat (Act) that do not require approval of a premarket approval application (PMA). and Oosmetic For ( 100 ) 100 ) reservly 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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean 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
Indications for Use
K043261 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Potassium Test Kit and Electrolyte Cal 1 and 2 Device Name:
Indications For Use:
The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Potassium in serum. Potassium is determined enzymatically via Potassium dependant pyruvate kinase activity using phosphoenolpyruvate as substrate. The pyruvate formed reacts with NADH in the presence of LDH to form lactate and NAD. The corresponding decrease in absorbance at 340 nm is proportional to the potassium concentration
Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Randox Electrolyte Cal 1 and 2
Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Potassium kit.
The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OROver-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 C. Benem
Division Sign-Off
Sas prim Villa Diagnostic Firsticallar and Safety
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