ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

K051646 · Pointe Scientific, Inc., · JGS · Oct 7, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051646
• Device Name: ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
• Applicant: Pointe Scientific, Inc.,
• Product Code: JGS · Clinical Chemistry
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

Pointe Scientific ISE reagents (Diluent, 1N KCl, Internal Reference, Standards) are aqueous solutions used with Roche Hitachi 917 analyzers. Device utilizes potentiometry to measure electromotive force changes between measuring and reference electrodes upon sample introduction. Changes in ionic concentration relative to internal reference standards allow calculation of Sodium, Potassium, and Chloride levels. Used in clinical laboratories by technicians to support diagnosis and treatment of electrolyte-related disorders. Output is quantitative electrolyte concentration, aiding clinical decision-making regarding patient metabolic status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reagent system for ion-selective electrode (ISE) analysis. Includes ISE Diluent, 1N KCL, Internal Reference, and ISE standards (Low and High). Classified as a chloride test system under 21 CFR 862.1170 (Product Codes: CGZ, CEM, JGS).

Indications for Use

Indicated for quantitative determination of sodium, potassium, and chloride in human serum to diagnose and treat electrolyte imbalances, including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, cystic fibrosis, and diabetic acidosis.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines. The symbol is positioned in the center of the circle.

Public Health Service

OCT 7 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. William F. Walters, Jr. V.P.- Technical Operations Pointe Scientific Inc. 5449 Research Drive Canton, MI 48188

k051646 Re:

Trade/Device Name: ISE Diluent, 1N KCL Internal Reference and ISE standards Low and High Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, CEM, JGS Dated: September 20, 2005 Received: September 22, 2005

Dear Mr. Walters:

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 noos mar have been 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 r head ou arrivade 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,

Carol C. Benam

Carol C. Benson, M.A. Acting 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): K051646

Device Name: ISE Diluent, 1N KCL, Internal Reference and ISE standards Low and High.

Indications For Use:

This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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)

C.J.C.K.

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

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