CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50

K990754 · Diagnostic Chemicals , Ltd. · KHS · Apr 20, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990754
• Device Name: CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Apr 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

For the quantitative determination of carbon dioxide in serum. For IN VITRO diagnostic use.

Device Story

The Carbon Dioxide - L3K Assay is an in vitro diagnostic reagent kit used for the quantitative measurement of carbon dioxide in serum samples. It is intended for use in clinical laboratory settings by trained laboratory personnel. Unlike traditional manometric, volumetric, or titrimetric techniques, this device utilizes an enzymatic procedure. The assay employs phosphoenolpyruvate carboxylase (PEPC) and a stabilized NAD analog to catalyze the reaction. The resulting measurement is performed on routine laboratory instrumentation. The output provides a quantitative value of CO2 concentration, which assists clinicians in diagnosing and monitoring respiratory acid-base imbalances, such as respiratory acidosis or alkalosis. The enzymatic method offers a more efficient and less cumbersome alternative to classic measurement techniques.

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 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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design.

APR 2 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Callbeck, R.T., B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 First Street West Royalty Industrial Park Charlottetown PE CIE 1B0 CANADA

Re: K990754

Trade Name: Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50 Regulatory Class: II Product Code: KHS Dated: March 5, 1999 Received: March 8, 1999

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 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 Regulations, 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.

{1}------------------------------------------------

Page 2

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 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

{2}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CQ, - L3K _______________________________________________________________________________________________________________________________________________________

## Indications for Use:

For the quantitative determination of carbon dioxide in 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-L3K assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog (3), which is easy to use and applicable to routine laboratory instrumentation.

Jean Cooger

(Division Sign-Off)
Division of Clinical
510(k) Numbe: K990754

(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

**Over-The-Counter Use** ***_***

(Optional Format 1-2-96)