(49 days)
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.
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This document is an FDA 510(k) clearance letter for the "Stat Profile pHOx Plus L Analyzer" and does not contain the detailed study information required to answer the prompt thoroughly. The letter confirms substantial equivalence to a predicate device and allows marketing, but it does not include the acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details of a comparative effectiveness study.
Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document is a regulatory approval, not a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol. The logo is black and white.
AUG 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Paul W. MacDonald Director of Quality Assurance/Regulatory Affairs Nova Biomedical Corp. 200 Prospect Street Waltham, MA 02254-9141
510(k) Number: K012058 Re: Trade/Device Name: Stat Profile pHOx Plus L Analyzer TraderDevice Namber: 862.1120, 862.1660, 862.1450, 862.6400, 862.6400, 862.1150, 862.1665, 862.1145, 862.1345, 862.3220, 862.5620 Regulatory Class: II Rogalatery Jorde: CHL, GKR, JIX, JGS, CEM, JFP, CGZ, CGA, JIP Regulatory Class: I Product Code: KHP Dated: June 29, 2001 Received: July 2, 2001
Dear Mr. MacDonald:
We have reviewed your Section 510(k) notification of intent to market the device referenced wo have lovice four bar buter is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameridate of max 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 the general vegistration, 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 Good Manufacturing Prodoculations of Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such penodio Shir million 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 region. Freasons on might have under sections 531 through 542 of the Act for devices under the any or agains of the Radiation Control provisions, or other Federal laws or regulations.
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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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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Indications for Use
510(k) Number: Kolao58
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 by health care The Stat Profile pHOX Plus Lanayal is intenties not in vitro alegrovination of pH, pCO2, pO2,
professionals and for Point-of-Care usage for the quantitative determination of professionals and for Point-of-Oare usage for the quantinized whole blood.
SO2%, Hct, Hb, Na+, K+, Cl-(or Ca++), Glu and Lac in heparinized whole blood.
(Please do not WRITE BELOW THIS LINE- CONTINỤE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Kezia Alexander Graham Cooper
Division of Clinical Labora 510(k) Number
Rx
§ 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.