(26 days)
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, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.
Intended for Point-of-Care Usage
Not Found
This document is a marketing clearance letter from the FDA for a device called "STAT Profile M Analyzer," not a study report. It does not contain information regarding acceptance criteria or a study that proves the device meets acceptance criteria.
The letter confirms that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This substantial equivalence determination is based on the information provided in the 510(k) premarket notification, but the letter itself does not detail the specific performance studies, acceptance criteria, or their quantitative results.
Therefore, I cannot provide answers to the requested information based on the provided text, as the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information about experts used to establish ground truth.
- Adjudication methods.
- Details of a multi-reader multi-case comparative effectiveness study or effect sizes.
- Results of a standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with a staff entwined by two snakes and topped with wings.
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.
{1}------------------------------------------------
Page 2
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 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 (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/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
{2}------------------------------------------------
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
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IFNEEDED)
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)
/ Prescription Use
§ 864.5600 Automated hematocrit instrument.
(a)
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).(b)
Classification. Class II (performance standards).