STAT PROFILE PHOX PLUS L ANALYZER

K012058 · Nova Biomedical Corp. · CHL · Aug 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012058
• Device Name: STAT PROFILE PHOX PLUS L ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 20, 2001
• Decision: SESE
• Submission Type: Traditional
• 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.

Device Story

Stat Profile pHOx Plus L Analyzer is an in vitro diagnostic device for point-of-care testing; analyzes heparinized whole blood samples; measures pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Cl- or Ca++), hematocrit (Hct), hemoglobin (Hb), oxygen saturation (SO2%), glucose (Glu), and lactate (Lac); provides quantitative results to healthcare professionals; assists in clinical decision-making regarding patient metabolic and respiratory status.

Clinical Evidence

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

Technological Characteristics

In vitro diagnostic analyzer for heparinized whole blood; utilizes electrochemical and optical sensing principles for blood gas, electrolyte, and metabolite quantification; benchtop form factor; intended for professional point-of-care use.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu, and Lac 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 U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol. The logo is black and white.

## AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

510(k) Number: K012058 Re: Trade/Device Name: Stat Profile pHOx Plus L Analyzer TraderDevice Namber: 862.1120, 862.1660, 862.1450, 862.6400, 862.6400, 862.1150, 862.1665, 862.1145, 862.1345, 862.3220, 862.5620 Regulatory Class: II Rogalatery Jorde: CHL, GKR, JIX, JGS, CEM, JFP, CGZ, CGA, JIP Regulatory Class: I Product Code: KHP Dated: June 29, 2001 Received: July 2, 2001

Dear Mr. MacDonald:

We have reviewed your Section 510(k) notification of intent to market the device referenced wo have lovice four bar buter is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameridate of max to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general vegistration, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Prodoculations of Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such penodio Shir million to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect region. Freasons on might have under sections 531 through 542 of the Act for devices under the any or agains of the Radiation Control provisions, or other Federal laws or regulations.

{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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

510(k) Number: Kolao58

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 by health care The Stat Profile pHOX Plus Lanayal is intenties not in vitro alegrovination of pH, pCO2, pO2,
professionals and for Point-of-Care usage for the quantitative determination of professionals and for Point-of-Oare usage for the quantinized whole blood.
SO2%, Hct, Hb, Na+, K+, Cl-(or Ca++), Glu and Lac in heparinized whole blood.

(Please do not WRITE BELOW THIS LINE- CONTINỤE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Kezia Alexander Graham Cooper

Division of Clinical Labora 510(k) Number

Rx