MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12

K042362 · Diagnostic Chemicals , Ltd. · KHS · Dec 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042362
• Device Name: MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Dec 27, 2004
• 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 and plasma. For IN VITRO diagnostic use.

Device Story

Carbon Dioxide-L3K Assay is an in vitro diagnostic reagent kit for measuring CO2 levels in serum and plasma. It replaces traditional manometric, volumetric, or titrimetric techniques with an enzymatic method. The assay utilizes phosphoenolpyruvate carboxylase (PEPC) and a stabilized NADH analog to catalyze a reaction proportional to the CO2 concentration in the sample. Designed for use on routine laboratory instrumentation, the assay provides quantitative results to clinicians for assessing respiratory acidosis or alkalosis. The procedure simplifies laboratory workflow by eliminating cumbersome acid-liberation steps, facilitating faster diagnostic turnaround for patients with suspected respiratory or metabolic CO2 imbalances.

Clinical Evidence

No clinical data. Performance established via bench testing: precision (CV 1.1-1.7%), linearity (2.9-50 mmol/L), and interference studies (icterus, lipemia, hemoglobin). Method comparison (n=45) against a predicate method yielded a correlation coefficient of 0.9861. Matrix recovery studies confirmed plasma equivalence to serum (96.9% vs 97.9% recovery).

Technological Characteristics

Enzymatic assay; liquid reagents containing buffer (pH 7.6), PEP, PEPC, malate dehydrogenase, NADH analog, activators, stabilizers, surfactant, and preservative. Requires instrumentation with temperature control (±0.5°C) and absorbance sensitivity of 0.001 at 405 or 415nm. Standardized via NCCLS EP6-P and EP9-A.

Indications for Use

Indicated for the quantitative determination of carbon dioxide in serum and plasma for in vitro diagnostic use in clinical laboratory settings.

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

DEC 27 2004

Ms. Marlene Walker Director of Quality Systems Diagnostic Chemicals Limited Diagnostic Division 16 McCarville Street West Royalty Industrial Park Charlottetown, Prince Edward, Canada C1E 2A6

k042362 Re:

> Trade/Device Name: Carbon Dioxide-L3K Assay Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: December 13, 2004 Received: December 14, 2004

Dear Ms. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely vours,

Carl C. Benson for

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042362

Device Name: Carbon Dioxide-L3K Assay

Indications For Use:

For the quantitative determination of carbon dioxide in serum and plasma. 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 (CO2) 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 NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evelination and Safety

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510(k) K042362