NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER

K980991 · Nova Biomedical Corp. · CHL · Apr 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980991
• Device Name: NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, PCO2, PO2, SO2%, and Hct in whole blood and for the analysis of expired (exhaled) gases.

Device Story

Stat Profile pHOx Analyzer is an in vitro diagnostic device for clinical laboratory or point-of-care use. It accepts whole blood samples or expired gas samples. The device utilizes electrochemical sensors to measure pH, PCO2, PO2, and Hct, and calculates SO2%. Results are displayed to the clinician to assist in patient management and diagnostic decision-making. Operated by healthcare professionals, the device provides rapid blood gas and electrolyte analysis to support critical care and respiratory monitoring.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

Electrochemical sensor-based analyzer for blood gas and electrolyte measurement. Measures pH, PCO2, PO2, Hct, and calculates SO2%. Designed for in vitro diagnostic use in clinical environments.

Indications for Use

Indicated for use by healthcare professionals for the quantitative determination of pH, PCO2, PO2, SO2%, and Hct in whole blood and analysis of expired (exhaled) gases to assist in patient management.

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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 5 1998

Paul W. MacDonald . Faul W. MacDonala
Director of Quality Assurance /Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, Massachusetts 02254-9141

Re : K980991 Stat Profile pHOx Analyzer Requlatory Class: II Product Code: CHL, GKF Dated: March 16, 1998 March 17, 1998 Received:

Dear Mr. MacDonald:

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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. 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 Bitman

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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**510(k) Number:** K980991

Device Name: Stat Profile pHOx Blood Gas Analyzer

## Indications for Use:

Intended Use

The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care The Stat Profile pHOX Analyzer is intended for in vill Claudiosco arous as and annon in and and on the management on (SO2%) and professionals in the quantiative detonimation of expired (exhaled) gases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------|---------|
| Division of Cimcer Laboratory vices | |
| 510(k) Number | 2480991 |

Prescription Use_K (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)