SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2

K043268 · Randox Laboratories, Ltd. · CEI · Feb 15, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043268
• Device Name: SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
• Applicant: Randox Laboratories, Ltd.
• Product Code: CEI · Clinical Chemistry
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant 9-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. 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 Sodium 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 Sodium Test Kit is an in vitro diagnostic reagent for quantitative serum sodium measurement. It utilizes an enzymatic method where sodium-dependent beta-galactosidase activity acts on an ONPG substrate; the resulting O-nitrophenyl product is measured via absorbance at 405 nm. The device is designed for use on Hitachi 704, 717, 902, and 911/912 analyzers. It is operated by qualified laboratory personnel in a clinical laboratory setting. The output is a sodium concentration value, which assists clinicians in diagnosing and managing electrolyte-related conditions such as dehydration, diabetes insipidus, and adrenal disorders. Randox Electrolyte Cal 1 and 2 are liquid calibrators used to calibrate sodium, potassium, and chloride electrodes on Hitachi ISE modules and the enzymatic sodium kit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay; reagents include buffer, β-galactosidase enzyme, and ONPG substrate. Aqueous calibrators contain NaCl and KCl. Designed for Hitachi 704, 717, 902, 911/912 analyzers. Photometric detection at 405nm. Two-point calibration.

Indications for Use

Indicated for the quantitative determination of sodium in serum to aid in the diagnosis and treatment of diseases involving electrolyte imbalance, including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, and inappropriate antidiuretic hormone secretion. For use by qualified laboratory personnel.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Submission Summary (Full Text)

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble waves or fabric.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 1 5 2005

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY

Re: k043268

> Trade/Device Name: Sodium Test Kit and electrolyte Cal 1 and 2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: CEI, 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, 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 [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, DVM

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

Unkgrown K043268 510(k) Number (if known):

Sodium Test kit and electrolyte Cal 1 and 2 Device Name:

Indications For Use:

## Randox Sodium Test Kit

The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant 9-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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 Sodium kit.

The Randox Electrolyte Cal 1 and 2 must only be used by suitable 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 C. Bensen

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510k K043268