(58 days)
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No
The provided 510(k) summary describes a blood gas analyzer and does not mention any AI or ML components or functionalities.
No
The device is an in vitro diagnostic analyzer used for quantitative determination of various analytes in blood, serum, and plasma, which is for diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for in vitro diagnostic use."
No
The device is described as an "Analyzer" which is a hardware device used for in vitro diagnostic testing. The description of the intended use clearly indicates the measurement of various analytes in blood, serum, and plasma, which requires physical interaction with biological samples, a function of hardware.
Yes, based on the provided information, the Stat Profile pHOx Plus L Analyzer is an IVD (In Vitro Diagnostic) device.
The "Intended Use / Indications for Use" section explicitly states:
"The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage..."
This statement directly identifies the device's intended purpose as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.
Product codes
CHL; GJS; CEM; JFP; CGZ; CGA; KHP: JIX; JPI; GKR; JPK; JKS
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 and for Point-of-Care usage
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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/0 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" around the perimeter. Inside the circle is a stylized design of three human figures, possibly representing health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEC 2 0 2002
Food and Drug Administration 2098 Gaither Road · Rockville MD 20850
Mr. Paul W. MacDonald Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, MA 02454-9141
Re: K023567
Trade/Device Name: Stat Profile pHOx Plus L. Analyzer Regulation Number: 21 CFR 862.1140 Regulation Name: Calcitonin Test System Regulatory Class: Class II Product Code: CHL; GJS; CEM; JFP; CGZ; CGA; KHP: JIX; JPI; GKR; JPK; JKS Dated: October 21, 2002 Received: October 23, 2002
Dear Mr. MacDonald:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for
510(k) Number:
Device Name: Stat Profile pHOx Plus L Analyzer
Indications for Use:
Intended Use
The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
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Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number -
PRESCRIPTION