(23 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device appears to be a standard blood gas analyzer.
No
The device is an in vitro diagnostic analyzer used for quantitative determination of various parameters in blood and expired gases, which makes it a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for in vitro diagnostic use."
No
The device is described as an "Analyzer" which is typically a hardware device used for in vitro diagnostic testing. The description of measuring parameters in "heparinized whole blood" and "expired (exhaled) gases" further indicates a physical device interacting with biological samples.
Yes, based on the provided information, the Stat profile pHOx Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".
- Sample Type: It analyzes "heparinized whole blood" and "expired (exhaled) gases," which are biological samples analyzed in vitro (outside the body).
- Measurements: It performs "quantitative determination" of various analytes (pH, PCO2, PO2, etc.) in these samples, which is a core function of IVD devices.
N/A
Intended Use / Indications for Use
The Stat profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (SO2%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.
Product codes
CHL, JIX, JJS, GKF, GKR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
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Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human services, with three vertical lines and flowing curves.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2 1998
Paul W. MacDonald Director of Quality Assurance /Regulatory Affairs Nova Biomedical 200 Prospect Street 02254-9141 Waltham, Massachusetts
Re : K982277 Stat Profile® pHOx Blood Gas Analyzer Regulatory Class: I & II Product Code: CHL, JIX, JJS, GKF, GKR Dated: June 26, 1998 Received: June 29, 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ 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 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 requlations.
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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/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:
Device Name: Stat Profile pHOx Blood Gas Analyzer
Indications for Use:
Intended Use:
The Stat profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (SO2%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K982277