EASYBLOOD GAS ANALYZER

K974526 · Medica Corp. · CHL · Feb 5, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974526
• Device Name: EASYBLOOD GAS ANALYZER
• Applicant: Medica Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The EasyBloodGas analyzer is designed for laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide) and PO2 (partial pressure of oxygen) on whole blood samples from syringes or capillary tubes.

Device Story

EasyBloodGas Analyzer is a laboratory instrument for blood gas analysis; measures pH, PCO2, and PO2 directly from whole blood samples; samples introduced via syringes or capillary tubes; provides quantitative diagnostic data for clinical assessment of patient acid-base and respiratory status; intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench-level performance characteristics for blood gas analysis.

Technological Characteristics

Benchtop analyzer for in vitro diagnostic use; measures pH, PCO2, and PO2 via electrochemical sensors; processes whole blood samples from syringes or capillary tubes.

Indications for Use

Indicated for laboratory use for the direct measurement of pH, PCO2, and PO2 in whole blood samples obtained via syringes or capillary tubes.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 5 1998

Photios Makris . Director of Quality Medica Corporation 14 DeAngelo Drive 01730 Bedford, Massachusetts

Re : K974526 Easy Blood Gas Analyzer Regulatory Class: II Product Code: CHL December 1,1997 Dated: Received: December 2, 1997

Dear Mr. Makris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set . forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Butman

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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K 974526/A1

Page __ 1 __ of _

510(k) NUMBER (IF KNOWN) : _ K974526

DEVICE NAME: __EasyBloodGas Analyzer

INDICATIONS FOR USE:

The EasyBloodGas analyzer is designed for laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide) and PO2 (partial pressure of oxygen) on whole blood samples from syringes or capillary tubes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

(Division Sign-Off
Division of Clinical Laboratory.Devices
510(k) Number. 97457

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