COBAS INTEGRA CARBON DIOXIDE ASSAY

K031879 · Roche Diagnostics Corp. · KHS · Jul 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031879
• Device Name: COBAS INTEGRA CARBON DIOXIDE ASSAY
• Applicant: Roche Diagnostics Corp.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3-) concentration in human serum and plasma.

Device Story

COBAS Integra Bicarbonate liquid is a ready-to-use enzymatic reagent system for use on COBAS Integra clinical chemistry analyzers. The assay utilizes phosphoenolpyruvate carboxylase and malate dehydrogenase to catalyze reactions where bicarbonate concentration is proportional to a decrease in absorbance measured at 409 nm. Used in clinical laboratory settings by trained technicians to analyze human serum and plasma samples. Results provide healthcare providers with quantitative bicarbonate levels to assess patient acid-base status, aiding in the diagnosis and management of metabolic and respiratory disorders.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance comparisons between the subject device and the predicate.

Technological Characteristics

Ready-to-use liquid enzymatic reagent containing phosphoenolpyruvate carboxylase and malate dehydrogenase. Operates via colorimetric absorbance measurement at 409 nm. Designed for use on automated COBAS Integra clinical chemistry systems.

Indications for Use

Indicated for the quantitative determination of bicarbonate concentration in human serum and plasma to assist in the diagnosis and treatment of disorders associated with acid-base balance changes.

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

• COBAS Integra Carbon Dioxide Assay (K980996)

Submission Summary (Full Text)

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# 510(k) Summary - COBAS Integra Bicarbonate liquid

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] | |
| | Contact person: Sherri L. Coenen | |
| | Date prepared: June 13, 2003 | |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra Bicarbonate liquid | |
| | Common name: Enzymatic Bicarbonate Assay | |
| | Classification name: enzymatic bicarbonate/carbon dioxide test system | |
| Device<br>description | The COBAS Integra Bicarbonate liquid is a ready-to-use liquid enzymatic<br>assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A<br>decrease in absorbance at 409 nm is proportional to the concentration of<br>bicarbonate in the sample. | |
| Intended use | The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro<br>diagnostic reagent system intended for use on COBAS Integra systems for the<br>quantitative determination of the bicarbonate ( $HCO_3^-$ ) concentration in human<br>serum and plasma. | |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed COBAS Integra<br>Carbon Dioxide Assay. (K980996). | |

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## 510(k) Summary - COBAS Integra Creatinine plus ver.2, continued

Reagent Summary The following table describes the similarities and differences between the COBAS Integra Bicarbonate liquid and the predicate device.

| Topic | COBAS Integra Carbon Dioxide<br>(K980996) | COBAS Integra Bicarbonate liquid<br>(Modified Device) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS Integra Carbon<br>Dioxide (CO2-S) contains an in vitro<br>diagnostic reagent system intended<br>for use on COBAS Integra systems<br>for the quantitative determination of<br>the carbon dioxide concentration in<br>serum and plasma. | The cassette COBAS Integra<br>Bicarbonate liquid (CO2-L) contains<br>an in vitro diagnostic reagent system<br>intended for use on COBAS Integra<br>systems for the quantitative<br>determination of the bicarbonate<br>$(HCO_3^-)$ concentration in human<br>serum and plasma. |
| Method | Enzymatic, colorimetric test | Same |
| Sample type | Human Serum and Plasma | Same |
| Measuring<br>range | 0 - 50 mmol/L | Same |
| Expected<br>values | Anaerobic venous plasma or serum:<br>23 - 29 mmol/L | 22 - 29 mmol/L |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 17 2003

Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k031879

> Trade/Device Name: COBAS Integra Bicarbonate liquid Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: June 13, 2003 Received: June 18, 2003

Dear Ms. Coenen:

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. Iisting 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 yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): N/A

Device Name: COBAS Integra Bicarbonate liquid

Indications For Use:

The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3) concentration in human serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031875

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Concurrentee of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use · / (Per 21 CFR 801.109)

(Optional Format 1-2-96)