STAT PROFILE PHOX PLUS C ANALYZER

K021713 · Nova Biomedical Corp. · CHL · Jul 25, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021713
• Device Name: STAT PROFILE PHOX PLUS C ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Stat Profile pHOx Plus C 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-, Ca++, and Glu in heparinized whole blood.

Device Story

Stat Profile pHOx Plus C Analyzer is an in vitro diagnostic device for point-of-care testing. It accepts heparinized whole blood samples to quantitatively measure pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Cl-, Ca++), hematocrit (Hct), hemoglobin (Hb), and glucose (Glu). Operated by healthcare professionals, the device provides rapid analytical results to assist in clinical decision-making regarding patient acid-base balance, electrolyte status, and metabolic state. It serves as a diagnostic tool in clinical settings to facilitate immediate patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance and technological characteristics.

Technological Characteristics

Benchtop analyzer for in vitro diagnostic use. Measures pH, blood gases, electrolytes, hematocrit, hemoglobin, and glucose in heparinized whole blood. Utilizes electrochemical and optical sensing principles common to blood gas and electrolyte analyzers. Operates as a standalone point-of-care system.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, and Glu in heparinized whole blood by healthcare professionals in point-of-care settings.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation. The birds are depicted in a simple, abstract manner.

Public Health Service

## JUL 2 5 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: k021713

> Trade/Device Name: Stat Profile pHOx Plus C Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (P.,2, P.2) and blood pH test system Regulatory Class: Class II Product Code: CHL; JGS; CEM; JEP; CGZ; CGA; JPI; GKR; JIX; JKS; JPK Dated: May 22, 2002 Received: May 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 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 comply 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.

{1}------------------------------------------------

Page 2 -

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 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/dsmaldsmamain.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

{2}------------------------------------------------

## Indications for Use

K021713 510(k) Number:

Device Name: Stat Profile pHOx Plus C Analyzer

Indications for Use:

Intended Use

The Stat Profile pHOx Plus C 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-, Ca++, and Glu in heparinized whole blood.

Sean Cooper
(Division Sign-Off)

ivision of Clinical Laboratory Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

prescriptim use X
(Per 21 CFR 801.109)