STAT PROFILE PHOX BASIC ANALYZER

K013729 · Nova Biomedical Corp. · CHL · Jan 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013729
• Device Name: STAT PROFILE PHOX BASIC ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by health care professionals for the measurement of pH, pCO2 and pO2 in heparinized whole blood. Measurements of blood gases and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Device Story

Stat Profile pHOx Basic Analyzer is an in vitro diagnostic device for clinical laboratory or point-of-care settings. It accepts heparinized whole blood samples to measure pH, pCO2, and pO2. Operated by healthcare professionals, the device provides quantitative results used to diagnose and manage acid-base disturbances. The system includes integrated calibration and quality control materials to ensure measurement accuracy. Results are displayed to the clinician to inform immediate therapeutic decisions for patients with life-threatening conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance specifications for blood gas and pH analysis.

Technological Characteristics

In vitro diagnostic analyzer for pH, pCO2, and pO2. Utilizes electrochemical sensors for blood gas analysis. Includes integrated calibrator and quality control materials. Designed for professional use in clinical settings.

Indications for Use

Indicated for in vitro diagnostic measurement of pH, pCO2, and pO2 in heparinized whole blood by healthcare professionals to diagnose and treat 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JAN 1 5 2002

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

k013729 Re:

Trade/Device Name: k013729 Trade Dovios Number: 21 CFR 862.1120; 21 CFR 862.1150; 21 CFR 862.1660 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system; Calibrator; Quality control material (assayed and unassayed) Regulatory Class: Class II; Class II; Class I Product Code: CHL; JIX; JJX; JJS Dated: November 8, 2001 Received: November 9, 2001

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as stated in the encreative to etgany in the Medical Device Amendments, or to conimered proc to may 20, 2017) 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 Tou may, therefore, mains 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 If your device is elaboried (tonal controls. Existing major regulations affecting your device can may oe subject to back acceral 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 I lease of actived that I Dr over device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I cach statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It rate 607); adoming (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinty of ovisions (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 nredicate 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 1 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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/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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## Indications for Use

510(k) Number: K013729

Device Name: Stat Profile pHOx Basic Analyzer

Indications for Use:

Intended Use

The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by health care The Stat Profile pHOX Basic Analyzer is intended for the May and Manager of pH, pCO2 and pO2 in heparinized whole blood.

Measurements of blood gases and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

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Division of Clinical Latic 510(k) Number