RX IMOLA

K052914 · Randox Laboratories, Ltd. · CEM · Mar 31, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052914
• Device Name: RX IMOLA
• Applicant: Randox Laboratories, Ltd.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required. The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. Various other clinical chemistry assays are adaptable to the analyzer. The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance. The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions. For in vitro diagnostic use only.

Device Story

RX Imola is a fully automated, medium-sized desktop clinical chemistry analyzer; includes integrated Ion Selective Electrode (ISE) unit. Inputs: serum, plasma, or urine samples. Operation: external PC controls analyzer; performs clinical chemistry assays and electrolyte measurements. Output: quantitative test results; printed or transmitted to host computer. Usage: clinical laboratory environment; operated by qualified personnel. Benefit: assists in diagnosis/treatment of electrolyte imbalances and magnesium-related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the clinical chemistry and ISE analytical systems.

Technological Characteristics

Desktop automated clinical chemistry analyzer; includes ISE unit for electrolyte measurement. Connectivity: external PC interface, host computer connectivity. Software-controlled operation. In vitro diagnostic use.

Indications for Use

Indicated for use by qualified laboratory personnel for the quantitative measurement of magnesium, sodium, potassium, and chloride in serum, plasma, and urine to aid in the diagnosis and treatment of electrolyte imbalances, hypomagnesaemia, and hypermagnesaemia.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAR 3 I 2006

Trade/Device Name: RX Imola, (Clinical Chemistry Analyser), ISE Unit & Magnesium Test Kit Regulation Number: 21 CFR§ 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM, CGZ, JGS, JGJ, JJE

Dated: February 20, 2006

Received: February 22, 2006

Dear Dr. Armstrong:

k052914

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) I ms lotter with and your he FDA finding of substantial equivalence of your device to a legally promation in the 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, r you don't 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,

Alberto G.

Alberto Gutierrez, Ph.D. 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):

NOT KNOWN

Device Name:

RX Imola, (Clinical Chemistry Analyser), ISE Unit & Magnesium Test Kit

## Indications For Use:

The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.

The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. Various other clinical chemistry assays are adaptable to the analyzer.

The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance.

The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions.

For in vitro diagnostic use only.

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)

Caitlin Brown

L 052914