← Product Code [CHL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL) · K050423 # OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) (K050423) _Roche Diagnostics · CHL · Apr 22, 2005 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K050423 ## Device Facts - **Applicant:** Roche Diagnostics - **Product Code:** [CHL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL.md) - **Decision Date:** Apr 22, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1120 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K050423 B. Purpose for Submission: Notification of intent to manufacture and market the device: The Omni Analyzers (OMNI Modular, Omni C, and Omni S) for use in the measurement of pleural fluid pH C. Measurand: Pleural Fluid D. Type of Test: Ion Selective Electrode E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Proprietary Name: Roche Diagnostics pH electrode on the OMNI Modular, C, and S Analyzers. G. Regulatory Information: 1. Regulation section: 21 CFR 862.1120 2. Classification: Class II 3. Product code: CHL 4. Panel: {1} 75, Clinical Chemistry ## H. Intended Use: 1. Intended use(s): See indication for below. 2. Indication(s) for use: ### 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 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. 3. Special conditions for use statement(s): Pleural fluid pH on the Roche Omni (Modular, C, and S) is to be used only in the pH range of 7.0 – 7.5 4. Special instrument requirements: For professional use only. ### I. Device Description: The Omni (Modular, C, and S) pH electrode uses the Sorensen 1909 principle which is based on the measurement of hydrogen ion (H⁺) concentration. The electrodes consist of a special H⁺ glass membrane and an accompanying Ag/AgCL reference electrode. The pH electrode is a component of an array of Ion Selective electrodes used to measure specific ions in the blood. ### J. Substantial Equivalence Information: {2} 1. Predicate device name(s): AVL model 995-Hb pH/blood gas analyzer and the CIBA-Corning Model 288 blood gas analyzer. 2. Predicate 510(k) number(s): k895317, k872888 3. Comparison with predicate: | Feature/Claim | Omni Analyzers (Modular, C and S) | AVL Model 995-Hb | CIBA-Corning Model 288 | | --- | --- | --- | --- | | Ph Measuring principle | Omni (Modular, C, and S) pH electrode uses the Sorensen 1909 principle which is based on the measurement of hydrogen ion (H⁺) concentration. | SAME | SAME | | Electrode Membrane | H⁺ sensitive glass membrane | SAME | SAME | | Reference Electrode | Ag/AgCl | Colomel | Ag/AgCl | | Concentration of the KCL Reference Solution | 1.2M | 0.6M | 4M | {3} K. Standard/Guidance Document Referenced (if applicable): No guidance or standard document referenced L. Test Principle: Ion Selective Electrode (ISE) M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision/Reproducibility was established in the initial submission of the OMNI Modular Analyzer (k990092), the OMNI C Analyzer (k013373) and the Omni S Analyzer (k032311) on whole blood. Further studies of the Precision/Reproducibility of pleural fluid pH were researched in literature on the predicate device. These findings are referenced in section P. - Other Supportive Device and Instrument Information. b. Linearity/assay reportable range: Linearity/assay reportable range was established in the initial submission of the OMNI Modular Analyzer (k990092), the OMNI C Analyzer (k013373) and the Omni S Analyzer (k032311) on whole blood. Further studies of the Linearity/assay reportable range of pleural fluid pH were researched in literature on the predicate device. These findings are referenced in section P. - Other Supportive Device and Instrument Information. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability, Stability, and Expected values (controls, calibrators, or methods) were established in the initial submission of the OMNI Modular Analyzer (k990092), the OMNI C Analyzer (k013373) and the Omni S Analyzer (k032311) on whole blood. Further studies of the Traceability, Stability, and Expected values (controls, calibrators, or methods) of pleural fluid pH were researched in literature on the predicate device. These findings are referenced in {4} section P. - Other Supportive Device and Instrument Information. d. Detection limit: Detection limit was established in the initial submission of the OMNI Modular Analyzer (k990092), the OMNI C Analyzer (k013373) and the Omni S Analyzer (k032311) on whole blood. Further studies of the Detection limit of pleural fluid pH were researched in literature on the predicate device. These findings are referenced in section P. - Other Supportive Device and Instrument Information. e. Analytical specificity: Analytical specificity was established in the initial submission of the OMNI Modular Analyzer (k990092), the OMNI C Analyzer (k013373) and the Omni S Analyzer (k032311) on whole blood. Further studies of the Analytical specificity of pleural fluid pH were researched in literature on the predicate device. These findings are referenced in section P. - Other Supportive Device and Instrument Information. f. Assay cut-off: Assay cut-off was established in the initial submission of the OMNI Modular Analyzer (k990092), the OMNI C Analyzer (k013373) and the Omni S Analyzer (k032311) on whole blood. Further studies of the Assay cut-off of pleural fluid pH were researched in literature on the predicate device. These findings are referenced in section P. - Other Supportive Device and Instrument Information. 2. Comparison studies: a. Method comparison with predicate device: Roche Diagnostics used regression analysis to determine the appropriate range for pleural fluid. The defined specification was a difference of no more than 0.7 pH units. 35 samples were used in the regression analysis. The correlation coefficient between the OMNI and {5} Roche 995 results was 0.998. The r-square for the linear model was 0.995. N=35 Y=0.896x + 0.8 Correlation 0.998 Values below 7.0 can be expected to show differences greater than 0.7 variation establishing the functional range of pleural pH as 7.0 – 7.5 b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Studies of the Expected values/Reference range of pleural fluid pH were researched and have been established in literature on the predicate device. These findings are referenced in section P. - Other Supportive Device and Instrument Information. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: {6} The submitted information in this premarket notification is complete and supports a substantial equivalence decision. P. Other Supportive Device and Instrument Information: Is pH paper an acceptable, low-cost alternative to the blood gas analyzer for determining pleural fluid pH? Lesho EP, Roth BJ. Chest 1997; 112:1291 – 1292 Comparison of Pleural Fluid pH Values Obtained Using Blood Gas Machine, pH Meter, and pH Indicator Strip. Cheng DS, Rodriguez RM, Rogers J, Wagster M, Starnes DL, Light RW. Chest 1998; 114:1368 – 1372. Comparison of the Use of Accuracy of Methods for Determining Pleural Fluid pH. Chandler TM, McCoskey EH, Byrd RP, Roy TM. Southern Medical Journal, February 1999; Volume 92, No. 2, pages 214 – 217. Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results, Thomas L. 1st Ed. (TH-Books, English Edition 1998) p. 1363 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K050423](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K050423) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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