CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01

K991108 · A.P. Total Care, Inc. · KHS · May 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991108
• Device Name: CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
• Applicant: A.P. Total Care, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: May 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

The carbon dioxide reagent (CO2), product No. CO107-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of CO2 in serum or plasma.

Device Story

Device is an in vitro diagnostic reagent for quantitative CO2 measurement in serum or plasma; used in automated laboratory analyzers; provides clinicians with CO2 concentration data to assist in metabolic and acid-base balance assessment; intended for prescription use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for automated chemical analysis of CO2 in serum or plasma samples.

Indications for Use

Indicated for the automated, quantitative determination of carbon dioxide (CO2) in human serum or plasma for in vitro diagnostic use.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAY 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

A.P. Total Care, Inc. Luis P. Leon c/o Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, CT

Re: K991108 Trade Name: Carbon Dioxide Requlatory Class: II Product Code: KHS March 25, 1999 Dated: April 1, 1999 Received:

Dear Mr. Leon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

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): Ky 99 | 110 B CARBON DIOXIDE (CO2) Device Name:_

Indications For Use:

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The carbon dioxide reagent (CO2), product No. CO107-01 is intended for Invitro The carbon dioxide Teagent (CO2), product 110) - Sec. - Sec.
Diagnostic use in the automated, quantitative determination of CO2 inserum or plasma.

Fran Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991108

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)