(63 days)
The Stat Profile pHOx Plus C 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-, Ca++, and Glu in heparinized whole blood.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Stat Profile pHOx Plus C Analyzer." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific details about acceptance criteria, study design, or performance data as typically found in a scientific study report or the original 510(k) submission.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: This information is not present.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance: While the device is for quantitative determination (implying standalone measurement), specific performance metrics (accuracy, precision, linearity) typically associated with standalone testing are not detailed here. The letter only clarifies its intended use and substantial equivalence.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What the document does tell us:
- Device Name: Stat Profile pHOx Plus C Analyzer
- Intended Use: 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-, Ca++, and Glu in heparinized whole blood.
- Regulatory Status: Substantially equivalent to predicate devices, Class II.
- Ground Truth (Implication): For this type of in-vitro diagnostic device, the "ground truth" for demonstrating substantial equivalence typically involves comparing the device's measurements against established reference methods or predicate devices using patient samples or control materials. However, the specifics of how this was done are not in this letter.
To obtain the detailed information you requested, you would need to access the full 510(k) submission (K021713) itself, which would contain the study reports and data. The FDA clearance letter only summarizes the outcome of their review, not the detailed evidence presented.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation. The birds are depicted in a simple, abstract manner.
Public Health Service
JUL 2 5 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: K021713
Trade/Device Name: Stat Profile pHOx Plus C Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (P.,2, P.2) and blood pH test system Regulatory Class: Class II Product Code: CHL; JGS; CEM; JEP; CGZ; CGA; JPI; GKR; JIX; JKS; JPK Dated: May 22, 2002 Received: May 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Page 2 -
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 1 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" (21CFR 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/cdrb/dsmaldsmamain.html".
Sincerely yours.
Steven Butman
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}------------------------------------------------
Indications for Use
K021713 510(k) Number:
Device Name: Stat Profile pHOx Plus C Analyzer
Indications for Use:
Intended Use
The Stat Profile pHOx Plus C 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-, Ca++, and Glu in heparinized whole blood.
Sean Cooper
(Division Sign-Off)
ivision of Clinical Laboratory Devices 510(k) Number
(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)
prescriptim use X
(Per 21 CFR 801.109)
§ 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.