EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER

K063376 · Medica Corp. · CHL · Jun 25, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063376
• Device Name: EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
• Applicant: Medica Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jun 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The EasyStat pH, PCO₂, PO₂, Htc, Na, K, Ca/Cl analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO₂ (partial pressure of carbon dioxide), PO₂ (partial pressure of oxygen), Htc (Hematocrit), Na⁺ (sodium ions), K⁺ (potassium ions), Ca²⁺ (ionized calcium) and Cl⁻ (chloride ions) in whole blood samples from syringes or capillary tubes. pH measurements are used in the diagnosis and treatment of diseases involving imbalance in the acid-base equilibrium in blood. PCO₂ measurements are used in the diagnosis and treatment of diseases involving imbalance in the partial pressure of carbon dioxide in blood. PO₂ measurements are used in the diagnosis and treatment of diseases conditions characterized by low or high blood oxygen levels in blood. Hematotric (Htc) measurements are used in the diagnosis and treatment of diseases characterized by erythrocyte imbalances in whole blood. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (ionized) measurements are used to determine the physiologically active form of calcium in blood and establish the patient’s calcium metabolism. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

Device Story

EasyStat analyzer performs direct electrochemical measurements of pH, PCO2, PO2, Htc, Na+, K+, Ca++, and Cl- in whole blood samples. Input samples are introduced via syringes or capillary tubes. Device utilizes electrochemical sensors to quantify ion activity and partial pressures; results are processed and displayed for clinical laboratory personnel. Output data assists clinicians in diagnosing and managing acid-base, electrolyte, and metabolic imbalances. Device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data. Performance established via bench testing, including precision studies (CLSI EP-5) and method comparison studies against predicate devices using patient samples. Precision evaluated across three levels of aqueous QC material. Method comparison showed high correlation (R² > 0.96) for all analytes across syringe and capillary modes.

Technological Characteristics

Ion-selective electrode (ISE) technology for potentiometric measurement of pH, PCO₂, Na⁺, K⁺, Ca²⁺, Cl⁻; amperometric Pt electrode for PO₂; electrical conductivity for Htc. Dimensions: 14.25"W x 12.5"H x 7"D. Power: 100-115VAC or 220VAC. Connectivity: RS-232 port for external PC, optional barcode reader. Calibration: Automatic two-point.

Indications for Use

Indicated for clinical laboratory use to measure pH, PCO2, PO2, Hematocrit, Na+, K+, ionized calcium, and chloride in whole blood samples from syringes or capillary tubes for the diagnosis and treatment of acid-base, electrolyte, metabolic, and oxygenation disorders.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2007

Medica Corporation c/o Dr. Photios Makris Director of Regulatory Affairs 5 Oak Park Drive Bedford, MA 01730

Re: k063376 Trade/Device Name: Easystat pH, Pco2, Po2, HTC, Na, K, Cl analyzer Regulation Number: 21 CFR §862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system. Regulatory Class: Class II Product Code: CHL, GKF, JGS, CEM, JFP, CGZ Dated: May 31, 2007 Received: June 05, 2007

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. 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. Cooper, M.S., D.V.M.

Jean 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):

Device Name: EasyStat pH, PCO2, PO2, Htc, Na , K , Ca * /Cl Analyzer

Indications For Use:

The EasyStat pH, PCO2, PO2, Htc, Na, K, Ca/Cl analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PO2 (partial pressure of oxygen), Htc (Hematocrit), Na * (sodium ions), K (potassium ions), Ca * (ionized calcium) and CI (chloride ions) in whole blood samples from syringes or capillary tubes.

pH measurements are used in the diagnosis and treatment of diseases involving imbalance in the acidbase equilibrium in blood.

PCO2 measurements are used in the diagnosis and treatment of diseases involving imbalance in the partial pressure of carbon dioxide in blood.

PO2 measurements are used in the diagnosis and treatment of diseases conditions characterized by low or high blood oxygen levels in blood.

Hematotric (Htc) measurements are used in the diagnosis and treatment of diseases characterized by erythrocyte imbalances in whole blood.

Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance and in the diagnosis and freatment of diseases conditions characterized by low or high blood potassium levels.

Calcium (ionized) measurements are used to determine the physiologically active form of calcium in blood and establish the patient's calcium metabolism.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

| Prescription Use | X |
|-----------------------------|---|
| (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)

GTC

Division/Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sa

063376

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