EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

K100829 · Medica Corp. · JGS · Jan 14, 2011 · Clinical Chemistry

Device Facts

• Record ID: K100829
• Device Name: EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
• Applicant: Medica Corp.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jan 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are 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. For in vitro diagnostic use only. The EasyRA potassium test is intended for the quantitative determination of potassium ions (K+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. The EasyRA chloride test is intended for the quantitative determination of chloride ions (Cl) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only. The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only.

Device Story

EasyRA assays (Sodium, Potassium, Chloride, Carbon Dioxide) are in vitro diagnostic reagents used with the Medica EasyRA Chemistry Analyzer. The system utilizes an Ion Selective Electrode (ISE) module for electrolyte measurement (Na+, K+, Cl-) and chemical reagents for CO2 determination. Operated by clinical laboratory personnel, the system processes human serum, plasma, or urine samples. The analyzer performs automated quantitative analysis, providing results to clinicians to assist in diagnosing and treating conditions like electrolyte imbalance, cystic fibrosis, and acid-base disorders. The device facilitates rapid clinical decision-making by providing objective electrolyte and metabolic data.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the assays on the EasyRA Chemistry Analyzer.

Technological Characteristics

System utilizes Ion Selective Electrode (ISE) technology for Na+, K+, and Cl- detection. CO2 is measured via chemical reagent assay. Designed for use with the Medica EasyRA Chemistry Analyzer. In vitro diagnostic use only.

Indications for Use

Indicated for quantitative determination of sodium, potassium, chloride, and bicarbonate/CO2 in human serum, plasma, and urine to diagnose/monitor electrolyte imbalances, metabolic disorders, and acid-base balance in clinical laboratory settings.

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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Public Health Service

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Medica Corporation c/o Dr. Photios Makris Director OA/RA 5 Oak Park Drive Bedford, MA 01730

Re: k100829

Trade Name: EasyRA Sodium Assay, EasyRA Potassium Assay, Easy RA Chloride Assay, Easy RA Carbon Dioxide Assay, Regulation Number: 21 CFR §862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Codes: JGS, CEM, CGZ, KHS Dated: December 16, 2010 Received: December 17, 2010

JAN 1 4 201

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, 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. Come

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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 (OS) regulation (21 CFR Part 820).

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,

C.H. Ph.D.

Courtney C. Harper, Ph.D. 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): K1008299

| Device Name: | EasyRA Sodium assay: |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are 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. For in vitro diagnostic use only. |
| Device Name: | EasyRA Potassium assay: |
| Indications For Use: | The EasyRA potassium test is intended for the quantitative determination of potassium ions (K+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. |
| Device Name: | EasyRA Chloride assay: |
| Indications For Use: | The EasyRA chloride test is intended for the quantitative determination of chloride ions (Cl) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only. |
| Device Name: | EasyRA Carbon Dioxide reagent: |
| Indications For Use: | The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only. |

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)

Carol C. Benam

Division Sign-Off

510(k)_

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