K Number
K013729
Device Name
STAT PROFILE PHOX BASIC ANALYZER
Date Cleared
2002-01-15

(67 days)

Product Code
Regulation Number
862.1120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by health care professionals in 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 Description
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More Information

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No
The summary describes a basic blood gas analyzer and contains no mention of AI, ML, or related concepts.

No
The device is an in vitro diagnostic (IVD) device used for measurement of blood gases and pH, which are diagnostic indicators, not therapeutic applications.

Yes
The "Intended Use / Indications for Use" section states: "The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use..." and "Measurements of blood gases and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances." This explicitly indicates its use in diagnosis.

No

The device is described as an "Analyzer" which measures pH, pCO2, and pO2 in whole blood. This strongly implies a physical hardware component is involved in the measurement process, not just software. The lack of a device description prevents definitive confirmation, but the nature of the measurements points away from a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

"The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by health care professionals..."

This statement directly identifies the device as an IVD.

N/A

Intended Use / Indications for Use

The Stat Profile pHOx Basic Analyzer is intended for in vitro diagnostic use by health care professionals for the measurement and monitoring 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.

Product codes

CHL; JIX; JJX; JJS

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

health care professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes.

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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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 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

2

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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Bevice Evaluation (ODE) oncurrence of CDRH, Office of

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prescription use

Okan Cooges


(Division Sign-Off)

Division of Clinical Latic 510(k) Number