CARBON DIOXIDE-SL ASSAY, CAT # 253-01

K983019 · Diagnostic Chemicals , Ltd. · KHS · Sep 14, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983019
• Device Name: CARBON DIOXIDE-SL ASSAY, CAT # 253-01
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

For the quantitative determination of carbon dioxide in human serum. For In Vitro diagnostic use.

Device Story

Carbon Dioxide-SL is an enzymatic in vitro diagnostic assay for measuring CO2 in human serum. It replaces traditional manometric, volumetric, or titrimetric techniques with an enzymatic procedure using phosphoenolpyruvate carboxylase (PEPC) and a stabilized NAD analog. Designed for use on routine laboratory instrumentation by clinical laboratory personnel. The assay provides quantitative CO2 measurements to assist clinicians in diagnosing and managing acid-base imbalances, specifically respiratory acidosis and alkalosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay utilizing phosphoenolpyruvate carboxylase (PEPC) and a stabilized NAD analog. Designed for use on routine clinical laboratory instrumentation. In vitro diagnostic reagent kit.

Indications for Use

Indicated for the quantitative determination of carbon dioxide in human serum for in vitro diagnostic use. Used to assess clinical conditions associated with elevated or decreased blood CO2 levels, such as respiratory acidosis or respiratory alkalosis.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 4 1998

Karen Callbeck, R.T.B.Sc. · Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

Re : K983019 Carbon Dioxide-SL Assay Regulatory Class: II Product Code: KHS Dated: August 28, 1998 Received: August 31, 1998

Dear Ms. Callbeck:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 In addition, FDA may publish further announcements action. 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 requlations.

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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/dsmamain.html" a

Sincerely yours,
Steven Gutman

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-SL, Cat. No. 253-01

## Indications for Use:

For the quantitative determination of carbon dioxide in human serum. For In Vitro diagnostic use.

Elevated blood CO2 is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide.

Decreased blood CO2 is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a primary decrease in carbon dioxide which can result from increased pulmonary ventilation due to mechanical ventilation of the respiratory center (1).

Classic techniques for the measurement of carbon dioxide (CO-) involve the addition of acid to liberate the carbon dioxide and the measurement of carbon dioxide thus released by either manometric, volumetric, or titrimetric techniques. These procedures are both time consuming and cumbersome. The DCL Carbon Dioxide-SL procedure is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog, which is easy to use and applicable to routine laboratory instrumentation.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laufey
510(k) Number. K983019

**Prescription Use**
(Per 21 CFR 801.109

OR

Over-The-Counter Use __

(Optional Format 1-2-96)