MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)

K982277 · Nova Biomedical Corp. · CHL · Jul 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982277
• Device Name: MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jul 22, 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, oxygen saturation (SO2%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.

Device Story

Stat Profile pHOx Analyzer is an in vitro diagnostic device for clinical laboratory or point-of-care use by healthcare professionals. It processes heparinized whole blood samples and expired gas samples to measure pH, PCO2, PO2, SO2%, hematocrit, and hemoglobin. The device provides quantitative analytical results to clinicians to assist in assessing patient respiratory and metabolic status. It operates as a benchtop analyzer; results are displayed for immediate clinical decision-making regarding patient oxygenation and acid-base balance.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and regulatory review of device specifications.

Technological Characteristics

Benchtop blood gas and gas analyzer. Measures pH, PCO2, PO2, SO2%, Hct, and Hb via electrochemical/potentiometric/amperometric sensing principles. Designed for professional in vitro diagnostic use.

Indications for Use

Indicated for in vitro diagnostic use by healthcare professionals for quantitative measurement of pH, PCO2, PO2, SO2%, Hct, and Hb in heparinized whole blood, and PCO2 and PO2 in exhaled gases.

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

## JUL 2 2 1998

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

Re : K982277 Stat Profile® pHOx Blood Gas Analyzer Regulatory Class: I & II Product Code: CHL, JIX, JJS, GKF, GKR Dated: June 26, 1998 Received: June 29, 1998

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 Gutman

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:

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 professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (SO2%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** ✓

OR

Over-The-Counter Use _

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K982277