STAT PROFILE M ANALYZER

K981427 · Nova Biomedical Corp. · GKF · May 12, 1998 · Hematology

Device Facts

• Record ID: K981427
• Device Name: STAT PROFILE M ANALYZER
• 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 Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, lactate, pH, PCO2, PO2, oxygen saturation, hemoglobin and hematocrit in serum, plasma and whole blood.

Device Story

Stat Profile Ultra M Analyzer is an in vitro diagnostic device for point-of-care or clinical laboratory use. It accepts whole blood, serum, or plasma samples. The device performs quantitative analysis of electrolytes, metabolites, blood gases, and hematology parameters. Results are displayed to healthcare professionals to assist in clinical decision-making regarding patient metabolic and respiratory status. It functions as a diagnostic tool for rapid assessment of patient physiological parameters.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic analyzer for blood chemistry and hematology. Measures sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, lactate, pH, PCO2, PO2, oxygen saturation, hemoglobin, and hematocrit. Designed for professional use in clinical or point-of-care settings.

Indications for Use

Indicated for in vitro diagnostic use by healthcare professionals for quantitative measurement of electrolytes (Na, K, Cl, ionized Ca), metabolites (glucose, urea nitrogen, lactate), blood gases (pH, PCO2, PO2), and hematology parameters (oxygen saturation, hemoglobin, hematocrit) in serum, plasma, and whole blood samples.

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 . Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street 02254-9141 Waltham, Massachusetts

K981427 Re : STAT Profile M Analyzer Requlatory Class: I & II GKF, GKR, CHL, JIX, CEM, CDS, 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 The general controls provisions of the Act 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 regulations 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 leqally 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 Gutman

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: K981427

Device Name: Stat Profile Ultra M Analyzer

Indications for Use:

intended Use

The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care The Gual Prome Shira in Antalier determination of sodium, potassium, chloride, ionized calcium, professionals in the quante, urea nitrogen, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Inc.

Intended for Point-of-Care Usage

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Vernica Calvin for a w Monigoxery
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K981427

(Optional Format 3-10-98)

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