OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)

K050423 · Roche Diagnostics · CHL · Apr 22, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050423
• Device Name: OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
• Applicant: Roche Diagnostics
• Product Code: CHL · Clinical Chemistry
• Decision Date: Apr 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Omni (Modular, C, and S) can be used for the measurement of pH in pleural fluid, as long as care is taken to ensure that the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport system. The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with paraneumonic effusions. Critical Values: pH>7.3 is measured in uncomplicated paraneumonic effusions. All pleural effusions with a pH of <7.3 are referred as complicated paraneumonic effusions; they are exudative in nature.

Device Story

The OMNI Modular, OMNI C, and OMNI S Analyzers utilize a pH electrode to measure hydrogen ion (H+) concentration in pleural fluid. The device operates on the Sorensen 1909 principle using an H+ sensitive glass membrane and an Ag/AgCl reference electrode. The system is intended for clinical use to assist in the management of patients with parapneumonic effusions. Users must ensure samples are clear of fibrin clots or debris to avoid blocking the sample transport system. The output provides a pH measurement, which clinicians use to inform diagnostic and therapeutic decisions regarding pleural effusions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by peer-reviewed literature articles comparing the OMNI analyzers to the predicate devices.

Technological Characteristics

pH electrode utilizing Sorensen 1909 principle; H+ sensitive glass membrane; Ag/AgCl reference electrode; 1.2 M KCl reference solution. System is designed for integration into OMNI Modular, OMNI C, and OMNI S blood gas analyzers.

Indications for Use

Indicated for the measurement of pH in pleural fluid in patients with parapneumonic effusions. Requires specimens to be free of fibrin clots or debris to prevent sample transport system blockage.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• AVL model 995-Hb pH/blood gas analyzer (k895317)
• CIBA-Corning Model 288 blood gas analyzer (k872888)

Submission Summary (Full Text)

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APR % 2 2005

K050423

| 510(k) Summary | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br><br>Contact Person: Dimitris Demirtzoglou<br><br>Date Prepared: February 17, 2005 |
| 2) Device name | Proprietary name: Roche Diagnostics pH electrode on the OMNI Modular, C<br>and S Analyzers<br><br>Common name: Electrode, Blood Gases (PCO2, PO2) and pH<br><br>Classification name: Electrode, Blood Gases (PCO2, PO2) and pH |
| 3) Predicate<br>device | The OMNI Analyzers (OMNI Modular, OMNI C and OMNI S) are<br>substantially equivalent to the AVL model 995-Hb pH/blood gas analyzer<br>(K895317) and the CIBA-Corning Model 288 blood gas system (K872888).<br>The AVL 995-Hb and CIBA-Corning 288 were the analyzers used in the<br>studies described in the peer reviewed literature articles. |
| 4) Device<br>Description | Expansion of the intended use for the pH electrode on the OMNI Modular,<br>OMNI C and OMNI S analyzers to allow for the measurement of pH in<br>pleural fluid. |
| | Continued on next page |

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# 510k Summary, Continued

| 5.) Intended<br>Use | We have expanded the claim for the pH electrode to include the following<br>text: | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|---------------------------|
| | Pleural Fluid: | | |
| | The Omni (Modular, C and S) can be used for the measurement of ph in<br>pleural fluid, as long as care is taken to ensure that the specimen to be<br>analyzed is clear of fibrin clots or other debris which may block the sample<br>transport system.<br><br>The pH measurement of pleural fluid can be a clinically useful tool in the<br>management of patients with parapneumonic effusions. | | |
| 6.) Similarities<br>and Differences | The table on the next page indicates the similarities and differences between<br>the pH electrodes in the OMNI Analyzers, the AVL model 995-Hb pH/blood<br>gas analyzer (literature article #1) and the CIBA-Corning Model 288 blood<br>gas analyzer (literature article #2). | | |
| Feature/Claim | OMNI Analyzers<br>(Modular, C and S) | AVL Model 995-Hb | CIBA-Corning<br>Model 288 |
| pH Measuring<br>Principle | OMNI uses the Sorensen 1909<br>principle which is based on<br>the measurement of hydrogen<br>ion (H⁺) concentration. | SAME | SAME |
| Electrode Membrane<br>Reference Electrode | H⁺ sensitive glass membrane<br>Ag/AgCl | SAME<br>Colomel | SAME<br>Ag/AgCl |
| Concentration of the<br>KCl Reference<br>Solution | 1.2 M | 0.6 M | 4 M |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 2 2 2005

Mr. Dimitris Demirtzoglou Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250

Re: k050423

k050423
Trade/Device Name: OMNI Modular, OMNI C and OMNI S Analyzer (pH Electrode) Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system Regulatory Class: Class II Product Code: CHL Dated: February 17, 2005 Received: February 18, 2005

Dear Mr. Demirtzoglou:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section - ro{x} premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to legally maneted povice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Editor For Area France commerce prior to May 20, 1770, the encenters with the provisions of the Federal Food. Drug, devices that have been reclassified in acceracited in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval incr and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, merelote, market me device, basjovite in the more ments for annual registration, listing of general controls of the Fiel Herenes of the Herelies against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (See acove) inro s. Existing major regulations affecting your device it may be subject to such additional controllar Childing (CFR), Parts 800 to 895. In addition, FDA call be found in Thic 21, Coub of I concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualies of a bassuitate with other requirements of the Act that FDA has made a decerminations administered by other Federal agencies. You must of any Federal statutes and regulations asimilations of the registration and listing (21 comply with an the Ace 3 requirements and and 809); and good manufacturing practice CFR Fall 807), labeling (21 CFR 710 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 premarket notification: "The I DTP Intember of 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 of questions on the promotion and Safety at [phone]. Also, please note the P in o Diagnostic Dolly by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the Tou may other belief general meetines 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,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. 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):

Device Name: OMNI Modular, OMNI C and OMNI S Analyzer (pH Electrode)

Indications For Use:

We have expanded the claim for the pH electrode to include the following text:

#### Pleural Fluid:

The Omni (Modular, C and S) can be used for the measurement of ph in pleural fluid, as a I he Onlin (Modular, C and by can oo be analyzed is clear of fibrin clots of fibrin clots or fong as care is which may block the sample transport system.

The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.

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

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

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K0504803

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