(67 days)
The EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PQ2 (partial pressure of oxygen),Hct (Hematocrit), Na* (sodium), K' (potassium), and Ca* (ionized calcium) on whole blood samples from syringes or capillary tubes.
This analyzer is used by laboratory trained technicians in the clinical laboratories to aide in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall patient clinical condition before corrective / therapeutic action is taken.
Not Found
This document is a 510(k) clearance letter from the FDA for the EasyStat pH, PCO2, PO2, Hct, Na+, K+, Ca++ Analyzer. It does not contain the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not publicly available in this FDA letter.
Therefore, I cannot provide the requested information based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Dean Honkonen Director of Regulatory Affairs Medica Corporation 14 DeAngelo Drive Bedford, MA 01730
JUL 1 6 2002
Re: K021515
Trade/Device Name: EasyStat pH, PCO2, PO2, Hct, Nat, K+, Ca++ Analyzer Regulation Number: 21 CFR 862.1120; 21 CFR 864.5600; 21 CFR 862.1665; 21 CFR 862.1600; 21 CFR 862.1145 Regulation Name: Blood gases (PCO2, PO2) and blood Ph test system; Automated hematocrit instrument; Sodium test system; Potassium test system; Calcium test system Regulatory Class: Class II Product Code: CHL; GKF; JGS; CEM; JFP Dated: May 7, 2002 Received: May 10, 2002
Dear Mr. Honkonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Page 1 of 1 510(k) Number (if known): Nat, K*, Ca* Analyzer Device Name: EasyStat pH, Indications for Use:
The EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PQ2 (partial pressure of oxygen),Hct (Hematocrit), Na* (sodium), K' (potassium), and Ca* (ionized calcium) on whole blood samples from syringes or capillary tubes.
This analyzer is used by laboratory trained technicians in the clinical laboratories to aide in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall patient clinical condition before corrective / therapeutic action is taken.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K0215/5
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98) (Posted July 1, 1998) Back to the Indications for Use Page
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.