EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER by MEDICA CORP.

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.

Device Description

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AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the EasyStat pH, PCO2, PO2, Htc, Na, K, Ca/Cl Analyzer, and it primarily focuses on the substantial equivalence determination and the device's indications for use. It does not contain details about:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance. (This device is for in-vitro diagnostic analysis of blood, not an AI-assisted diagnostic imaging device).
If a standalone (algorithm only) performance study was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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: