ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID

K032377 · Roche Diagnostics Corp. · KHS · Aug 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032377
• Device Name: ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
• Applicant: Roche Diagnostics Corp.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

The COBAS Integra Bicarbonate liquid (K031879) contains an in vitro diagnostic reagent system for use on the Cobas Integra system for the quantitative determination of bicarbonate concentration in human serum and plasma. The modified device Roche/Hitachi Bicarbonate liquid is an in vitro device for the quantitative determination of bicarbonate in human serum and plasma on Roche clinical analyzer systems.

Device Story

Roche/Hitachi Bicarbonate liquid is a ready-to-use enzymatic assay for quantitative bicarbonate measurement in human serum and plasma. It utilizes phosphoenolpyruvate carboxylase and malate dehydrogenase enzymes. The assay is performed on Roche automated clinical chemistry analyzers in clinical laboratory settings. The principle of operation involves a decrease in absorbance at 415 nm, which is proportional to the bicarbonate concentration in the sample. Healthcare providers use the resulting quantitative values to diagnose and monitor disorders related to body acid-base balance. The device provides automated, high-throughput testing capabilities for clinical diagnostic use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ready-to-use liquid enzymatic reagent system. Enzymes: phosphoenolpyruvate carboxylase and malate dehydrogenase. Detection: colorimetric, absorbance decrease at 415 nm. Form factor: reagent cassette for automated clinical chemistry analyzers. Connectivity: integrated with Roche automated clinical chemistry systems.

Indications for Use

Indicated for the quantitative determination of bicarbonate concentration in human serum and plasma for clinical diagnostic 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

• COBAS Integra Bicarbonate liquid (K031879)

Submission Summary (Full Text)

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## AUG 2 1 2003

# く032377
510(k) Summary - Roche/Hitachi Bicarbonate liquid

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: July 30, 2003 |
| Device Name | Proprietary name: Roche Diagnostics Hitachi Bicarbonate liquid<br><br>Common name: Bicarbonate Assay<br><br>Classification name: Enzymatic bicarbonate/carbon dioxide test system |
| Device description | The Roche/Hitachi Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 415 nm is proportional to the concentration of bicarbonate in the sample. |
| Intended use | In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche automated clinical chemistry analyzers. |
| Predicate Device | We claim substantial equivalence to the currently marketed COBAS Integra Bicarbonate liquid Assay. (K031879). |

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## 510(k) Summary - Roche/Hitachi Bicarbonate liquid, continued

| Reagent | The following table describes the similarities and differences between the |
|---------|----------------------------------------------------------------------------|
| Summary | Roche/Hitachi Bicarbonate liquid and the predicate device. |

| Topic | COBAS Integra Bicarbonate liquid (K031879) | Roche/Hitachi Bicarbonate liquid (Modified Device) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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>(HCO3-) concentration in human<br>serum and plasma. | In vitro test for the quantitative<br>determination of bicarbonate (HCO3-)<br>in human serum and plasma on<br>Roche clinical chemistry analyzers. |
| Method | Enzymatic, colorimetric test | Same |
| Sample type | Human Serum and Plasma | Same |
| Measuring range | 0.46 - 50 mmol/L | 1.5 - 50 mmol/L |
| Expected values | 22 - 29 mmol/L | Same |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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AUG 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k032377

> Trade/Device Name: Roche/Hitachi Bicarbonate liquid Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: July 30, 2003 Received: August 1, 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, 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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#### Page 2 -

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 Putman

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

032377

Device Name: Roche/Hitachi Bicarbonate liquid

Indications For Use:

In vitro test for the quantitative determination of bicarbonate (HCO3) in human serum and plasma on Roche automated clinical chemistry analyzers. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Carol C Benson (G. Jean Cooper, DVM
==Division Sign-Off==

Division Sign-C

Office of In Vitro Diagnostic Devise Evaluation and Safety

510(k) K032377

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

(Optional Format 1-2-96)