STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS

K981425 · Nova Biomedical Corp. · GKF · May 12, 1998 · Hematology

Device Facts

• Record ID: K981425
• Device Name: STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
• Applicant: Nova Biomedical Corp.
• Product Code: GKF · Hematology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5600
• Device Class: Class 2

Intended Use

The StatProfile Ultra A,B,C,D and E Analyzers are intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Device Story

Stat Profile Ultra A, B, C, D, and E Analyzers are point-of-care diagnostic instruments; used by healthcare professionals in clinical settings. Device accepts serum, plasma, or whole blood samples; performs quantitative analysis of electrolytes (sodium, potassium, ionized calcium, ionized magnesium), metabolites (glucose, lactate), blood gases (pH, PCO2, PO2), and hematology parameters (oxygen saturation, hemoglobin, hematocrit). Analyzers process samples to provide rapid diagnostic results; output assists clinicians in immediate patient assessment and management decisions. System facilitates bedside testing; reduces turnaround time compared to central laboratory analysis.

Clinical Evidence

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

Technological Characteristics

In vitro diagnostic analyzer; measures electrolytes, metabolites, blood gases, and hematology parameters via electrochemical and optical sensing principles. Designed for point-of-care use. System architecture supports multiple configurations (A, B, C, D, E).

Indications for Use

Indicated for in vitro diagnostic use by healthcare professionals for quantitative measurement of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, hemoglobin, and hematocrit in serum, plasma, and whole blood samples. Intended for point-of-care clinical settings.

Regulatory Classification

Identification

An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 1998

Paul W. MacDonald radi :: hasboroof Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, Massachusetts 02254-9141

K981425 Re : STAT Profile Ultra A, B, C, D, and E Analyzers Requlatory Class: I & II GKF, GKR, CHL, JIX, CEM, JFP, CGA, Product Code: JGS, KHP, JJS, CFA Dated: April 16, 1998 Received: April 16, 1998

Dear Mr. MacDonald:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Admin#stration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number: K981425

Device Name: Stat Profile Ultra A,B,C,D and E Analyzers

Indications for Use:

Intended Use

The StatProfile Ultra A,B,C,D and E Analyzers are intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Intended for Point-of-Care Usage

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Vernon A. Melvin Ford Montgomery
Division Staff Officer

Laboratory Devices

(Optional Format 3-10-98)

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