EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

K100673 · Medica Corp. · JGS · Apr 6, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100673
• Device Name: EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
• Applicant: Medica Corp.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Apr 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The EasyLyte analyzers are used for the in-vitro diagnostic testing of Sodium (Na+), Potassium (K+), chloride (C1-), and Lithium (Li) in clinical laboratories by trained technicians. Sodium test: The sodium (Na+) assay is intended to measure sodium in serum, plasma, whole blood and urine. Sodium measurements 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. Potassium test: The potassium (K+) assay is intended to measure potassium in serum, plasma, whole blood and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride test: The chloride (Cl-) assay is intended to measure the level of chloride in plasma, serum, whole blood, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Lithium test: The lithium (Li+) assay is intended to measure lithium (from the drug lithium carbonate) in serum, plasma and whole blood. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Device Story

EasyLyte Na/K/Cl/Li Analyzer is an in-vitro diagnostic system for clinical laboratories. It measures electrolyte concentrations (Na+, K+, Cl-, Li+) in serum, plasma, whole blood, and urine samples. Operated by trained technicians, the device utilizes ion-selective electrode (ISE) technology to measure potential differences across selective membranes, which are proportional to ion activity. The system processes these electrical signals to calculate and display concentration values. Results assist healthcare providers in diagnosing and managing electrolyte-related conditions, metabolic disorders, and therapeutic drug monitoring for lithium. The device provides rapid, automated analysis to support clinical decision-making regarding patient fluid and electrolyte status or medication dosage adjustments.

Clinical Evidence

No clinical data provided; the submission relies on bench testing and substantial equivalence to existing predicate devices.

Technological Characteristics

Ion-selective electrode (ISE) technology; measures potential differences proportional to ion activity. Analyzes serum, plasma, whole blood, and urine. Standalone benchtop analyzer.

Indications for Use

Indicated for in-vitro diagnostic testing of sodium, potassium, chloride, and lithium in serum, plasma, whole blood, and urine. Used by trained technicians in clinical laboratories to diagnose and monitor electrolyte imbalances, metabolic disorders (e.g., cystic fibrosis, diabetic acidosis), and to monitor lithium therapy for bipolar disorder.

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/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Medica Corp. c/o Photios Makris, Ph.D. 5 Oak Park Drive Bedford, Massachusetts 01730

Re: k100673

APR 0 5 2010

Trade/Device Name: EasyLyte Na/K/Cl/Li Analyzer Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ, JIH, JJE Dated: March 5, 2010 Received: March 9, 2010

Dear Dr. Makris:

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. Iisting 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, 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): _ K 100 673

EasyLyte Na/K/Cl/Li Analyzer Device Name:

Indications For Use: The EasyLyte analyzers are used for the in-vitro diagnostic testing of Sodium (Na+), Potassium (K+), chloride (C1-), and Lithium (Li) in clinical laboratories by trained technicians.

## Sodium test

The sodium (Na+) assay is intended to measure sodium in serum, plasma, whole blood and urine. Sodium measurements 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.

### Potassium test

The potassium (K+) assay is intended to measure potassium in serum, plasma, whole blood and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

### Chloride test

The chloride (Cl-) assay is intended to measure the level of chloride in plasma, serum, whole blood, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

#### Lithium test

The lithium (Li+) assay is intended to measure lithium (from the drug lithium carbonate) in serum, plasma and whole blood. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Prescription Use X (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)

Senson and Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

14100 673 510(k)