JAS CARBON DIOXIDE LIQUID REAGENT

K012332 · Jas Diagnostics, Inc. · KHS · Sep 6, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012332
• Device Name: JAS CARBON DIOXIDE LIQUID REAGENT
• Applicant: Jas Diagnostics, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended 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.

Device Story

JAS Carbon Dioxide Liquid Reagent is an in vitro diagnostic reagent used for the quantitative determination of carbon dioxide in human serum. The device is intended for use on automated chemistry analyzers in clinical laboratory settings. It is operated by laboratory technicians or clinical staff. The reagent reacts with serum samples to facilitate the measurement of carbon dioxide levels, which are then used by clinicians to assess a patient's acid-base balance. This information assists in the diagnosis and management of various metabolic and respiratory disorders. The device is provided for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics typical of in vitro diagnostic reagents for carbon dioxide measurement.

Technological Characteristics

Liquid reagent for in vitro diagnostic use; designed for compatibility with automated chemistry analyzers; utilizes standard biochemical assay principles for carbon dioxide quantification in serum.

Indications for Use

Indicated for the in vitro, quantitative determination of carbon dioxide in human serum for patients requiring assessment of acid-base balance to aid in the diagnosis and treatment of associated disorders.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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 _________________________________________________________________________________________________________________________________________________________

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