STAT PROFILE M7 ANALYZER

K991727 · Nova Biomedical Corp. · CGL · Jul 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991727
• Device Name: STAT PROFILE M7 ANALYZER
• Applicant: Nova Biomedical Corp.
• Product Code: CGL · Clinical Chemistry
• Decision Date: Jul 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, chloride, ionized calcium, creatinine, glucose, lactate, and BUN in serum, plasma and whole blood.; of pH, PCO2, PO2, oxygen saturation, hematocrit and hemoglobin in whole blood.

Device Story

Stat Profile Ultra M7 Analyzer is an in vitro diagnostic device for clinical and Point-of-Care settings. It processes serum, plasma, or whole blood samples to quantitatively measure electrolytes, metabolites, and blood gas/hematology parameters. Operated by healthcare professionals, the device provides rapid analytical results to assist in clinical decision-making regarding patient metabolic and respiratory status. It functions as a benchtop analyzer, transforming biological sample inputs into numerical diagnostic outputs displayed for the clinician.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review process.

Technological Characteristics

Benchtop in vitro diagnostic analyzer. Measures electrolytes, metabolites, and blood gas/hematology parameters via electrochemical or optical sensing principles. Designed for professional use in clinical and Point-of-Care environments.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of electrolytes (Na, K, Cl, ionized Ca), metabolites (creatinine, glucose, lactate, BUN), and blood gas/hematology parameters (pH, PCO2, PO2, oxygen saturation, hematocrit, hemoglobin) in serum, plasma, and whole blood samples. Intended for use by healthcare professionals in clinical and Point-of-Care settings.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 16 1999

Mr. Paul W. Mac Donald Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, Massachusetts 02254-9141

Re: K991727 Trade Name: Stat Profile M 7 Analyzer Regulatory Class: II Product Code(s): CGL, CHL, JGS, CEM, JFP, CGA, CDS, KHP CGZ, JKS, JPI, GLY Dated: May 19, 1999 Received: May 20, 1999

Dear Mr. Mac Donald:

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 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). 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 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 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 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Toutman

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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## K 991727 510(k) Number:

Device Name: Stat Profile Ultra M7 Analyzer

Indications for Use:

Intended Use

The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, chloride, ionized calcium, creatinine, glucose, lactate, and BUN in serum, plasma and whole blood.; of pH, PCO2, PO2, oxygen saturation, hematocrit and hemoglobin in whole blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number .

Rx X

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