(57 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Stat Profile M 7 Analyzer" (later referred to as "Stat Profile Ultra M7 Analyzer"). It does not contain the detailed technical specifications, acceptance criteria, or study results that would typically describe the device's performance against specific metrics.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the provided text.
The document primarily focuses on:
- Confirming substantial equivalence to a predicate device.
- Outlining regulatory requirements and controls.
- Stating the intended use and analytes the device measures.
To answer your questions, one would need to review the original 510(k) submission (K991727) or other technical documentation provided by Nova Biomedical for the Stat Profile Ultra M7 Analyzer.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three birds in flight, arranged in a stacked formation.
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 (770) 488-7655.
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 (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"(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 (800) 638-2041 or (301) 443-6597, 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
31
§ 862.1225 Creatinine test system.
(a)
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.(b)
Classification. Class II.