(45 days)
Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Carbon Dioxide Liquid Reagent. This document approves the device but does not contain the acceptance criteria or the study details that prove the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text. The text only confirms the device's classification and allows its marketing based on substantial equivalence to a predicate device, but it does not detail the performance study findings or acceptance criteria.
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SEP - 6 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Johnston JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166
Re: K012332
Trade/Device Name: JAS Carbon Dioxide Liquid Reagent Regulation Number: 21 CFR 862.1160 Regulatory Class: II Product Code: KHS Dated: July 2, 2001 Received: July 23, 2001
Dear Mr. Johnston:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have levelowed your with device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Intersate commore prive to hat have been reclassified in accordance with the provisions of the Amendinonis, of to devices 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 officers provision, 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 (1 remarker ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodic on. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, 1 27 Thia) publication submission submission submission submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the any oongained you t 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/cdrb/dsma/dsmamain.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
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _ Carbon Dioxide REAGENT Indications for Use:
Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander by Jean Cooper
Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012332
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.