STAT PROFILE PHOX PLUS L ANALYZER

K023567 · Nova Biomedical Corp. · CHL · Dec 20, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023567
• Device Name: STAT PROFILE PHOX PLUS L ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.

Device Story

Stat Profile pHOx Plus L Analyzer is a point-of-care diagnostic device for clinical laboratory use. It accepts heparinized whole blood, serum, or plasma samples. The device performs quantitative electrochemical and photometric analysis to measure pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Cl-, Ca++), hematocrit (Hct), hemoglobin (Hb), glucose (Glu), and lactate (Lac). Operated by healthcare professionals in clinical settings, the analyzer provides rapid results to assist in patient assessment and clinical decision-making regarding metabolic and respiratory status. The output is displayed for immediate review by the clinician.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Benchtop analyzer utilizing electrochemical sensors and photometric detection. Measures pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Glucose, and Lactate. Designed for point-of-care and clinical laboratory environments. Operates on heparinized whole blood, serum, or plasma.

Indications for Use

Indicated for health care professionals and Point-of-Care use for quantitative measurement of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Glucose, and Lactate in heparinized whole blood, serum, or heparinized plasma.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

## DEC 2 0 2002

Food and Drug Administration 2098 Gaither Road · Rockville MD 20850

Mr. Paul W. MacDonald Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, MA 02454-9141

Re: k023567

Trade/Device Name: Stat Profile pHOx Plus L. Analyzer Regulation Number: 21 CFR 862.1140 Regulation Name: Calcitonin Test System Regulatory Class: Class II Product Code: CHL; GJS; CEM; JFP; CGZ; CGA; KHP: JIX; JPI; GKR; JPK; JKS Dated: October 21, 2002 Received: October 23, 2002

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 general controls provisions 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for

510(k) Number:

K023567

Device Name: Stat Profile pHOx Plus L Analyzer

Indications for Use:

Intended Use

The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number -

PRESCRIPTION