DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A

K060619 · Diazyme Laboratories · KHS · Jul 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060619
• Device Name: DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
• Applicant: Diazyme Laboratories
• Product Code: KHS · Clinical Chemistry
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

Diazyme Carbon Dioxide Enzymatic Assay is for the in vitro quantitative determination of carbon dioxide content in human serum or plasma. Diazyme Carbon Dioxide Controls are assayed QC materials for use in quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma. They are intended as reference samples for monitoring the Diazyme Carbon Dioxide Enzymatic Assay.

Device Story

In vitro diagnostic assay for quantitative CO2 measurement in serum/plasma; utilizes enzymatic reaction principle; requires single-point calibrator and 0.9% saline zero reference to establish linear calibration curve; includes control set for quality assurance of assay functionality; intended for clinical laboratory use; results assist clinicians in evaluating patient acid-base status.

Clinical Evidence

No clinical data. Performance was established through bench testing, including precision (CV 1.7-3.3%), linearity (recoveries 90-106%), limit of detection (1.12 mM), and interference studies. Method comparison against a commercially available assay using 120 patient samples (60 serum, 60 plasma) showed correlation coefficients of 0.9859 and 0.9731, respectively.

Technological Characteristics

Enzymatic spectrophotometric assay using phosphoenolpyruvate carboxylase (PEPC) and malate dehydrogenase (MDH). Reagents include PEP, PEPC, NADH, and MDH. Calibrator and controls consist of sodium bicarbonate in saline/buffer. Requires instrument with 37°C temperature control and 405/415 nm absorbance reading. Complies with CLSI guidelines EP5-A, EP6-A, EP7-A, and EP9-A.

Indications for Use

Indicated for the quantitative determination of carbon dioxide (CO₂) in human serum and plasma for professional 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.

Predicate Devices

• Carbon Dioxide-L3K Assay (k990754)

Submission Summary (Full Text)

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(JUL 2 1 2006

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is k060619.

| Submitter's name: | Diazyme Laboratories |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's address: | 3550 General Atomics Court |
| | San Diego, CA 92121 |
| Phone: | 858-455-4761 |
| Fax: | 858-455-4750 |
| Name of Contact Person: | Roland Strickland |
| | Diazyme Laboratories |
| | 3550 General Atomics Court |
| | San Diego, CA 92121 |
| | Phone: [phone] |
| | Fax: [phone] |
| Date the summary was prepared: | February 23, 2006 |
| Name of the device: | In Vitro Bicarbonate/Carbon Dioxide Test System |
| Trade Name: | Diazyme Carbon Dioxide Enzymatic Assay |
| Common/Usual Name: | Bicarbonate/Carbon Dioxide Test System |
| Classification Name: | Enzymatic, Carbon-Dioxide |
| Device Class | II |
| Predicate Device: | The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: CARBON DIOXIDE-L3K ASSAY (k990754) manufactured by Diagnostic Chemicals Limited, Oxford, CT, USA. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Roland Strickland Quality Assurance Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121

JUL 2 1 2006

k060619 Re:

> Trade/Device Name: Diazyme Carbon Dioxide Enzymatic Assay Kit Diazyme Carbon Dioxide Control Set Regulation Number: 21 CFR8862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS, JJX Dated: June 30, 2006 Received: July 7, 2006

Dear Mr. Strickland:

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/industry/support/index.html.

Sincerely yours,

Alberto G.

Alberto Gutierrez, Ph.D 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: k060619 Device Name: Diazyme Carbon Dioxide Enzymatic Assay Kit Diazyme Carbon Dioxide Control Set Indications For Use: Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples. Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.

Prescription Use X (Part 21 CFR 801 Subpart D)

રૂકા

AND/OR

Over-The-Counter Use (21 CFR 801 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) | |
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| DIAZYME LABORATORIES DIVISION, GENERAL ATOMICS<br>150 GENERAL ATOMICS COURT, SAN DIEGO, CA 92121-1194<br>PO BOX 85608, SAN DIEGO, CA 92186 5608<br>[phone] | Page 14 |