RANDOX RX DAYTONA

K024014 · Randox Laboratories, Ltd. · CGA · Dec 4, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024014
• Device Name: RANDOX RX DAYTONA
• Applicant: Randox Laboratories, Ltd.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The RX Daytona is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples. The analyzer can be used to run tests including glucose in serum samples. Various other assays are adaptable to the analyzer. Glucose measurements may be used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell carcinoma. An Ion Selective Electrode (ISE) unit is an optional addition, which may be used with the RX Daytona Analyzer for the measurement of the electrolytes sodium, potassium and chloride in serum, plasma or urine. The ISE unit consists of ion selective electrodes, supply and drain pump, preamplifier board and I/O board. Sodium measurements may be used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic hormone secretion or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases characterized by low or high levels of potassium. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The RX Daytona analyzer and ISE unit must only be used by suitably qualified personnel, under appropriate laboratory conditions. For in vitro diagnostic use only.

Device Story

RX Daytona is an automated clinical chemistry analyzer for in vitro diagnostic use in laboratory settings by qualified personnel. It processes serum, plasma, or urine samples using photometric assays and an optional Ion Selective Electrode (ISE) unit. The system utilizes barcode identification for samples and reagents; integrates with host computers for test selection. Photometric unit performs enzymatic assays (e.g., glucose); ISE unit measures sodium, potassium, and chloride via ion electrode potential comparison against a reference electrode. The device provides quantitative results to clinicians for diagnosis and monitoring of metabolic and electrolyte disorders. It includes a QC database for result storage, trend analysis, and Westgard rule application.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use as an automated clinical chemistry analyzer.

Technological Characteristics

Automated clinical chemistry analyzer; photometric and ion selective electrode (ISE) sensing principles. ISE module includes reference electrode, supply/drain pump, preamplifier, and I/O board. Supports routine and STAT modes. Calibration methods include factor, single/multi-calibrator, linear, point-to-point, log-logit, spline, and exponential. Connectivity via host computer interface; barcode sample identification.

Indications for Use

Indicated for patients requiring clinical chemistry analysis of serum, plasma, or urine to diagnose/monitor carbohydrate metabolism disorders (diabetes, hypoglycemia, carcinoma) and electrolyte imbalances (aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, cystic fibrosis, diabetic acidosis).

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC = 4 2003

Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories, Limited 55 Diamond Road Crumlin, County Antrim United Kingdom BT29 4QY

Re: k024014

> Trade/Device Name: RX DAYTONA Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, JGS, CEM, CGZ, JJF, JIX Dated: September 3, 2003 Received: September 5, 2003

Dear Dr. Hamilton:

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 (OS) 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K024014

RX DAYTONA Device Name

(CLINICAL CHEMISTRY ANALYSER)

## Indications For Use:

The RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software. Software functions of the analyser include the facility to interact with a host computer Sonthare fantalo fancilerian selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples.

The analyser can be used to run tests including glucose in serum samples. Various other rro analyson be accent be analyser. Glucose measurements may be used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell carcinoma.

An Ion Selective Electrode (ISE) unit is an optional addition, which may be used with the AI Daytona Analyser for the measurement of the electrolytes sodium, potassium and chloride in serum, or urine. The ISE unit consists of ion selectrodes, supply and drain pump, preamplifier board and I/O board.

Sodium measurements may be used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases characterised by low or high levels of potassium. Chloride measurements are used in the diamosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The RX Daytona analyser and ISE unit must only be used by suitably qualified personnel, under appropriate laboratory conditions.

For in vitro diagnostic use only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Carol Bensen for Jean Cooper, DVM*

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | <i>K024014</i> |
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| Prescription Use<br>(Per 21 CFR 801.109) | |
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OR

Over-The-Counter (Optional form