STAT PROFILE PHOX ANALYZER

K014295 · Nova Biomedical Corp. · CHL · Feb 28, 2002 · Clinical Chemistry

Device Facts

• Record ID: K014295
• Device Name: STAT PROFILE PHOX ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Feb 28, 2002
• 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 and for Point-of-Care users in the quantitative determination of pH, pCO2, pO2, tHb, Hct and tHb in whole blood. Whole blood of pH, pCO2, pO2, tHb, Hct and tHb in the diagnosis and treatment of life-threatening acid-base disturbances.

Device Story

Stat Profile pHOx Analyzer is an in vitro diagnostic device for whole blood analysis; measures pH, pCO2, pO2, tHb, and Hct. Used by healthcare professionals and point-of-care users in clinical settings to diagnose and treat acid-base disturbances. Device processes whole blood samples to provide quantitative results; assists clinicians in rapid decision-making for critical care patients.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

In vitro diagnostic analyzer for blood gas and hematology parameters. Utilizes electrochemical sensing principles for pH, pCO2, and pO2, and optical or electrochemical methods for hemoglobin and hematocrit. Designed for whole blood analysis in clinical and point-of-care environments.

Indications for Use

Indicated for use by healthcare professionals and Point-of-Care users for the quantitative determination of pH, pCO2, pO2, tHb, and Hct in whole blood to aid in the diagnosis and treatment of life-threatening acid-base disturbances.

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 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 symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of interconnectedness and representing the department's focus on people and well-being.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 2 8 2002

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

k014295 Re: Trade/Device Name: Stat Profile pHOx Analyzer Regulation Number: 21 CFR 862.1120; 21 CFR 862.1150; 21CFR 862.1660; 21 CFR 864.5600; 21 CFR 864.5620 Regulation Name: Blood gases (Poo2, Po2) and blood pH test system; Calibrator; Quality control material (assayed and unassayed); Automated hematocrit instrument; Automated hemoglobin system Regulatory Class: Class II, Class II; Class II; Class II; Class I Product Code: CHL; JIX; GKF; GKR; JJS Dated: December 27, 2001 Received: December 28, 2001

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have rowe 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 for ass black in the 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 I ou mayy ato se or visions 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 or any I 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 (QS) 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 rills letter will and w you as organizatial equivalence of your device to a legally marketed noutheation. The I Dr intention 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 1 II you desire specific acrice is a received devices), please contact the Office of Compliance at additionally 607.10 for its for questions on the promotion and advertising of your device, [phone]. Tructionally, rollance at [phone]. 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 illionifacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrb/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

510(k) Number: K014295

Device Name: Stat Profile pHOx Analyzer

Indications for Use:

## Intended Use

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Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
§10(k) Number K014295

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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