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 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 parapneumonic effusions.

Device Description

Expansion of the intended use for the pH electrode on the OMNI Modular, OMNI C and OMNI S analyzers to allow for the measurement of pH in pleural fluid.

AI/ML Overview

This 510(k) premarket notification describes the expansion of the intended use for the pH electrode on the OMNI Modular, OMNI C, and OMNI S analyzers to allow for the measurement of pH in pleural fluid. The submission references studies described in peer-reviewed literature articles for predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) for the OMNI analyzers measuring pH in pleural fluid. Instead, it relies on the substantial equivalence to predicate devices and their established performance as detailed in peer-reviewed literature. The core of the claim is that the OMNI analyzers use the same fundamental pH measuring principle and similar electrode components as the predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Inferred from Predicate Equivalence)
pH Measuring Principle: Sorensen 1909 principle.	OMNI uses the Sorensen 1909 principle.
Electrode Membrane: H⁺ sensitive glass membrane.	OMNI uses H⁺ sensitive glass membrane.
Reference Electrode: Ag/AgCl or equivalent.	OMNI uses Ag/AgCl (Predicate AVL uses Colomel, Predicate Ciba-Corning uses Ag/AgCl).
Performance equivalent to predicate devices in measuring pH.	The OMNI analyzers are asserted to be "substantially equivalent" to predicate devices (AVL model 995-Hb and CIBA-Corning Model 288), which were used in the described peer-reviewed literature articles for pH measurement.
Suitable for pH measurement in pleural fluid with caveats.	The device "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."

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on a specific test set or sample size used for the OMNI analyzers specifically for pleural fluid pH measurement. Instead, it refers to studies conducted on predicate devices (AVL model 995-Hb and CIBA-Corning Model 288) as described in "peer-reviewed literature articles." The specific details of these studies (e.g., sample size, country of origin, retrospective/prospective nature) are not included in this 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The 510(k) relies on previous peer-reviewed literature for predicate devices, and the details regarding ground truth establishment within those studies are not discussed here.

4. Adjudication Method for the Test Set

This information is not provided. As no specific test set for the OMNI device and pleural fluid pH is presented, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided document. The device is an automated analyzer, not a system that assists human readers in interpretation.

6. Standalone Performance Study

The 510(k) submission implicitly relies on the standalone performance of the predicate blood gas analyzers, which is assumed to be established through the "peer-reviewed literature articles" mentioned. However, no new standalone study specific to the OMNI device measuring pH in pleural fluid is detailed in this document. The submission aims to demonstrate substantial equivalence to devices whose performance is already accepted.

7. Type of Ground Truth Used

The type of ground truth used in the referenced predicate device studies is not explicitly stated in this document. For pH measurements in biological fluids, the ground truth would typically be established by a reference method or a highly accurate laboratory standard.

8. Sample Size for the Training Set

No training set or sample size for a training set is mentioned. This 510(k) is for a medical device (analyzer) rather than an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/machine learning algorithm is mentioned.

Summary

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APR % 2 2005

K050423

510(k) Summary
Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
1) Submittername, address,contact	Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250(317) 521-7688Contact Person: Dimitris DemirtzoglouDate Prepared: February 17, 2005
2) Device name	Proprietary name: Roche Diagnostics pH electrode on the OMNI Modular, Cand S AnalyzersCommon name: Electrode, Blood Gases (PCO2, PO2) and pHClassification name: Electrode, Blood Gases (PCO2, PO2) and pH
3) Predicatedevice	The OMNI Analyzers (OMNI Modular, OMNI C and OMNI S) aresubstantially equivalent to the AVL model 995-Hb pH/blood gas analyzer(K895317) and the CIBA-Corning Model 288 blood gas system (K872888).The AVL 995-Hb and CIBA-Corning 288 were the analyzers used in thestudies described in the peer reviewed literature articles.
4) DeviceDescription	Expansion of the intended use for the pH electrode on the OMNI Modular,OMNI C and OMNI S analyzers to allow for the measurement of pH inpleural fluid.
	Continued on next page

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510k Summary, Continued

5.) IntendedUse	We have expanded the claim for the pH electrode to include the followingtext:
	Pleural Fluid:
	The Omni (Modular, C and S) can be used for the measurement of ph inpleural fluid, as long as care is taken to ensure that the specimen to beanalyzed is clear of fibrin clots or other debris which may block the sampletransport system.The pH measurement of pleural fluid can be a clinically useful tool in themanagement of patients with parapneumonic effusions.
6.) Similaritiesand Differences	The table on the next page indicates the similarities and differences betweenthe pH electrodes in the OMNI Analyzers, the AVL model 995-Hb pH/bloodgas analyzer (literature article #1) and the CIBA-Corning Model 288 bloodgas analyzer (literature article #2).
Feature/Claim	OMNI Analyzers(Modular, C and S)	AVL Model 995-Hb	CIBA-CorningModel 288
pH MeasuringPrinciple	OMNI uses the Sorensen 1909principle which is based onthe measurement of hydrogenion (H⁺) concentration.	SAME	SAME
Electrode MembraneReference Electrode	H⁺ sensitive glass membraneAg/AgCl	SAMEColomel	SAMEAg/AgCl
Concentration of theKCl ReferenceSolution	1.2 M	0.6 M	4 M

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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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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 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 (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 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)

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

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

La Keating
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Office of In Vitro Diagnostic Device Evaluation and

K0504803

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Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.