ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER

K070531 · Thermo Fisher Scientific · CGZ · Sep 4, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070531
• Device Name: ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
• Applicant: Thermo Fisher Scientific
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Sep 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Intended Use

The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes. Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma. Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases. Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis. The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.

Device Story

ISE module for DataPro™ Plus Clinical Chemistry Analyzer; utilizes ion-selective electrodes (ISE) to measure sodium, potassium, and chloride concentrations in serum samples. Device operates within a clinical laboratory setting; used by trained laboratory personnel. Input consists of serum samples; output is quantitative electrolyte concentration values. Clinicians use these results to assess fluid, acid-base, and electrolyte homeostasis, aiding in the diagnosis and management of conditions like renal failure, heart failure, and metabolic acidosis. Benefits include rapid, accurate electrolyte monitoring to guide clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ion-selective electrode (ISE) technology for potentiometric measurement of sodium, potassium, and chloride. Module integrates with DataPro™ Plus Clinical Chemistry Analyzer. In vitro diagnostic system.

Indications for Use

Indicated for quantitative determination of sodium, potassium, and chloride in serum for patients with suspected fluid, acid-base, or electrolyte imbalances, including renal failure, congestive heart failure, cirrhosis, and neurological disorders. For in vitro diagnostic use only.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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 features a stylized eagle with three stripes forming its body and wing. The eagle faces left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Thermo Fisher Scientific c/o Bola Nicholson Technical and Operations Manager 171 Industry Drive Pittsburgh, PA 15275-1034

SEP - 4 2007

Re: k070531

Trade/Device Name: ISE Module for the DataPro™ Plus Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride Test Regulatory Class: Class II Product Code: CGZ, CEM, JGS Dated: July 03, 2007 Received: July 09, 2007

Dear Bola Nicholson:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopes, M.S., D.v.M.

Sean M. Cooper, M.S., 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

510(k) Number (if known): K070531

Device Name: ISE Module for the DataPro™ Plus

Indications for Use: The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes.

Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma.

Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases.

Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis.

The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR ..

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carl C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety