POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2

K043267 · Randox Laboratories, Ltd. · CEJ · Feb 10, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043267
• Device Name: POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
• Applicant: Randox Laboratories, Ltd.
• Product Code: CEJ · Clinical Chemistry
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended 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.

Device Story

The Randox Potassium Test Kit is an in vitro diagnostic reagent system for serum potassium measurement. It utilizes an enzymatic method where potassium-dependent pyruvate kinase converts phosphoenolpyruvate to pyruvate; pyruvate reacts with NADH and LDH to produce lactate and NAD. The resulting decrease in absorbance at 340 nm is measured spectrophotometrically and is proportional to potassium concentration. The system is designed for use on Hitachi 704, 717, 902, and 911/912 analyzers. It is operated by qualified laboratory personnel in clinical laboratory settings. The device includes liquid calibrators (Electrolyte Cal 1 and 2) for the calibration of sodium, potassium, and chloride electrodes on Hitachi ISE modules and the enzymatic potassium kit. Results assist healthcare providers in diagnosing and managing electrolyte imbalances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay; reagents include buffer, enzyme substrate, diluent, and enzyme. Calibrators are aqueous solutions of electrolyte salts (NaCl, KCl) and preservatives. Designed for Hitachi 704, 717, 902, 911/912 analyzers. Measures absorbance at 340nm.

Indications for Use

Indicated for the quantitative determination of potassium in serum to monitor electrolyte balance in patients with conditions characterized by abnormal blood potassium levels. For use by qualified laboratory personnel.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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

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## 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

K043267

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