← Product Code [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM) · K032311 # ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311) _Roche Diagnostics Corp. · CEM · Oct 17, 2003 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K032311 ## Device Facts - **Applicant:** Roche Diagnostics Corp. - **Product Code:** [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM.md) - **Decision Date:** Oct 17, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1600 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry - **Attributes:** Pediatric ## Indications for Use The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate. ## Device Story Omni S Analyzer is a fully automated critical care analyzer; measures pH, blood gases, electrolytes, hematocrit, glucose, lactate, urea/BUN, and hemoglobin derivatives. Inputs: whole blood, serum, plasma, or aqueous solutions. Operation: utilizes blood gas, ISE, and MSS sensor modules; incorporates Braunstein technology for glucose/lactate; features enhanced sample detection and standby solution aspiration. Output: quantitative analytical results for the measured parameters. Used in clinical settings by healthcare professionals to support critical care decision-making. Benefits: provides rapid, comprehensive diagnostic data from a single platform, improving workflow efficiency via consolidated reagent packs. ## Clinical Evidence Bench testing only. The device demonstrates substantial equivalence through comparative analysis of sensor modules, sample types, and analytical performance parameters against the predicate Omni Modular and Omni C systems. ## Technological Characteristics Fully automated analyzer. Technologies: Ion Selective Electrode (ISE), enzymatic, MSS chamber sensors, Braunstein technology. Connectivity: PC-based interface, barcode reader, network of microcontrollers for data acquisition/sensor handling. Calibration: Automated 8-24 hour cycles; O2 sensor recalibrated every 30 minutes. Sample handling: Capillary, syringe, sealed containers. Standards: NCCLS EP6-P, NCCLS E5-T. ## Regulatory Identification A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. ## Predicate Devices - Omni Modular Analyzer ([K990092](/device/K990092.md)) - Omni C Analyzer ([K013373](/device/K013373.md)) ## 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 DEVICE AND INSTRUMENT TEMPLATE A. 510(k) Number: K032311 B. Analyte: Potassium, Calcium, Sodium, Chloride, Blood Gases (PCO2, PO2) and pH, Hemoglobin, Hematocrit, Oxygen Saturation, Carboxyhemoglobin, Oxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Lactic Acid, Glucose, Urea Nitrogen. C. Type of Test: Ion selective electrode – Potassium, Chloride, Sodium, Calcium, Blood gases, pH and Urea Nitrogen Colorimetric – Glucose Enzymatic – Lactic Acid D. Applicant: Jennifer Tribbett Roche Diagnostics Patient Care Division 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250 E. Proprietary and Established Names: Proprietary Name: The Roche OMNI S Analyzer. Established name – Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxy-carboxy and methemoglobin F. Regulatory Information: 1. Regulation section: 862.1600, 862.1145, 862.1665, 862.1170, 862.1120, 862.1450, 862.1345, 862.1770, 864.5620, 864.5600, 864.7425, 864.7500 2. Classification: Class II 3. Product Code: Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin - GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS. {1} Page 2 of 11 4. Panel: 75, 81 ## G. Intended Use: 1. Intended use(s): The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. 2. Indication(s) for use: The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. 3. Special condition for use statement(s): none 4. Special instrument Requirements: none ## H. Device Description: The Roche Omni S is an analyzer with an integrated AutoQC drawer option. Depending upon combination and configuration, the following parameters can be measured in whole blood, serum, plasma, acetate and bicarbonate containing dialysis solutions and QC materials. ## I. Substantial Equivalence Information: 1. Predicate device name(s): Omni Modular Analyzer and Omni C Analyzer 2. Predicate K number(s): Omni Modular Analyzer (K990092) and Omni C Analyzer (K013373) 3. Comparison with predicate: | Similarities & Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Intended use | The Roche Diagnostics Omni S Analyzer is intended to be used for the measurement of | The Roche Diagnostics Omni Modular Analyzer is intended to be used for the measurement of | {2} Page 3 of 11 | | pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. | pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, sulfhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. | | --- | --- | --- | | Parameters measured | pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen | The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin, and oxygen saturation, in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. | {3} Page 4 of 11 | | saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin | calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, sulfhemoglobin, and methemoglobin | | --- | --- | --- | | Sample types | Samples of whole blood, serum, plasma, and aqueous solutions as appropriate. | The Roche Diagnostics Omni C Analyzer: pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin, and oxygen saturation Same for both predicate devices | J. Standard/Guidance Document Referenced (if applicable): NCCLS EP6-P, NCCLS – E5-T, and Reviewer Guidance for Computer Controlled Medical Devices undergoing 510(k) review. K. Test Principle: Ion Selective Electrode, Enzymatic, Sensor (O2 saturation). L. Performance Characteristics (if/when applicable): 1. Analytical performance: Precision/Reproducibility: With-in run (SWR) and Total (ST) precision were determined from 2 runs a day with 2 replicates per run for 20 days on four Roche Omni S instruments using samples of each specimen type suitable for measurement on the analyzer. All assays available on the Omni S were evaluated as appropriate for the specimen type. {4} Page 5 of 11 a. Linearity/assay reportable range: Linearity was established by utilizing the NCCLS Document EP6-P. Tonometered whole blood: Whole blood was tonometered at 37°C to various levels of gravitimetrically prepared gases with CO2 and O2 concentrations certified to 0.03% absolute by the manufacturer. Expected and observed values were corrected to 760 mmHg. Aqueous solutions: Expected values for the aqueous solutions were based on weighted samples. NIST Standards: NIST standards are precise serums with accredited target values. Hematocrit: Measurements for the hemofuge, which represents the gold standard for hematocrit measurements, was used as expected values for hematocrit results. The linearity for each analyte was described as follows: PO2 – slope 0.9904-1.0097 Intercept +/- 0.857 Correlation 0.9998 Range 0 – 800mmHg PCO2 – slope 0.9898 – 1.0103 Intercept +/- 1.225 Correlation 0.9999 Range 4 – 200mmHg pH – slope 0.9825 – 1.0178 Intercept +/- 0.133 Correlation 0.998 Range 6.0 – 8.0 Hct– slope 0.997 – 1.003 Intercept +/- 0.620 Correlation 0.999 Range 10 80% Sodium – slope 0.988 – 1.012 Intercept +/- 0.365 Correlation 0.9999 Range 20 – 250mmol/L Potassium – slope 0.960 – 1.042 Intercept +/- 0.109 Correlation 0.9999 Range 0.2 - 20 mmol/L Ion. Calcium – slope 0.975 – 1.026 Intercept +/- 0.024 Correlation 0.9999 Range 0.1 – 4.0 mmol/L Chloride – slope 0.959 – 1.043 Intercept +/- 2.908 Correlation 0.9999 Range 20 – 250 mmol/L Glucose – slope 0.919 – 1.088 Intercept +/- 1.773 Correlation 0.998 Range 0.5 – 40 mmol/L Lactate – slope 0.961 – 1.041 Intercept +/- 0.191 Correlation 0.9989 Range 0.2 – 20 mmol/L Urea – slope 0.979 – 1.021 Intercept +/- 0.198 Correlation 0.9991 Range 0.5 – 30 mmol/L Total Hgb – slope 0.9892 – 1.0109 Intercept +/- 0.0833 Correlation 0.9904 Range 3 - 25 g/dl SO2 – slope 0.99999 – 1.00001 Intercept +/- 0.856 Correlation 0.9874 Range 50 – 100% b. Traceability (controls, calibrators, or method): Tonometered whole blood, aqueous solutions, NIST standards c. Detection limit: Detection Limits for analytes on the Omni S Analyzer are defined on the Omni S Analyzer as the linear range of each assay. The assays performed on the Omni S are measured with established normal and critical ranges for each {5} Page 6 of 11 analyte. These ranges fall well within the linearity of the respective assays. d. Analytical specificity: Tonometered whole blood: Whole blood was tonometered at 37°C to various levels of gravitimetrically prepared gases with CO2 and O2 concentrations certified to 0.03% absolute by the manufacturer. Expected and observed values were corrected to 760 mmHg. Aqueous solutions: Expected values for the aqueous solutions were based on weighted samples. NIST Standards: NIST standards are precise serums with accredited target values. Hematocrit: Measurements for the hemofuge, which represents the gold standard for hematocrit measurements, was used as expected values for hematocrit results. e. Assay cut-off: The assay cut-off is established as the linearity range of the Roche Omni S for each analyte. 2. Comparison studies: a. Method comparison with predicate device: External testing was conducted to demonstrate the correlation of the Omni S analyzer to legally marketed devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed were remnant from patient samples of whole blood, serum and plasma collected from routine analysis on existing instrumentation. The Omni S has incorporated the same blood gas modules, ISE modules, total hemoglobin and Oxygen saturation, MSS chamber sensors for BUN/urea nitrogen as with the predicate devices. For lactate and glucose the Omni S utilizes Braunstein technology. The correlations to the predicate devices are as follows: pH, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.063 + 1.009 * X, Bias +0.007, Corr. Coeff. [r] = 0.990, # samples = 134 pH, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -0.496 + 0.933 * X, Bias +0.003, Corr. Coeff. [r] = 0.990, # samples = 99 pO2, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.643 + 1.031 * X, Bias +1.6, Corr. Coeff. [r] = 0.987, # samples = 136, Unit (mmHG) {6} Page 7 of 11 pO2, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -4.433 + 1.013 * X, Bias +6.6, Corr. Coeff. [r] = 0.996, # samples = 137, Unit (mmHG) pCO2, Comparison Instrument - Omni C, Slope/Intercept - Y = -1.452 + 1.038 * X, Bias +1.6, Corr. Coeff. [r] = 0.987, # samples = 129, Unit (mmHG) pCO2, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -0.301 + 1.000 * X, Bias +0.4, Corr. Coeff. [r] = 0.988, # samples = 144, Unit (mmHG) tHb, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = 0.581 + 1.083 * X, Bias +2.0, Corr. Coeff. [r] = 0.814, # samples = 96, Unit (g/dl) Sodium, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -13.193 + 1.106 * X, Bias +0.9, Corr. Coeff. [r] = 0.948, # samples = 108, Unit (mmol/L) Sodium, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -2.143 + 1.106 * X, Bias +0.9, Corr. Coeff. [r] = 0.972, # samples = 107, Unit (mmol/L) Potassium, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.126 + 1.020 * X, Bias -1.4, Corr. Coeff. [r] = 0.986, # samples = 131, Unit (mmol/L) Potassium, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -2.143 + 1.106 * X, Bias +0.9, Corr. Coeff. [r] = 0.972, # samples = 107, Unit (mmol/L) Calcium, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.039 + 1.024 * X, Bias -0.8, Corr. Coeff. [r] = 0.941, # samples = 131, Unit (mmol/L) Calcium, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -0.096 + 1.073 * X, Bias -1.1, Corr. Coeff. [r] = 0.981, # samples = 98, Unit (mmol/L) Chloride, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -12.459 + 1.118 * X, Bias -0.7, Corr. Coeff. [r] = 0.960, # samples = 139, Unit (mmol/L) {7} Page 8 of 11 Chloride, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = 17.100 + 0.800 * X, Bias -4.0, Corr. Coeff. [r] = 0.965, # samples = 98, Unit (mmol/L) SO2, Comparison Instrument - Omni Modular, Slope/Intercept - Y = 10.066 + 0.903 * X, Bias 1.1, Corr. Coeff. [r] = 0.991, # samples = 130, Unit (%) SO2, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -3.969 + 1.037 * X, Bias -4.0, Corr. Coeff. [r] = 0.904, # samples = 102, Unit (%) MetHb, Comparison Instrument - Omni Modular, Deviation of mean -0.3% abs, # samples = 129 MetHb, Comparison Instrument - Radiometer 725, , Deviation of mean +0.2% abs, # samples = 131 COHb, Comparison Instrument - Omni Modular, Deviation of mean 0.7% abs, # samples = 130 COHb, Comparison Instrument - Radiometer 725, , Deviation of mean +0.1% abs, # samples = 132 Hct, Comparison Instrument - Omni Modular, Slope/Intercept - Y = 0.100 + 1.00 * X, Bias 0.4, Corr. Coeff. [r] = 0.967, # samples = 132, Unit (%) Hct, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -0.689 + 1.040 * X, Bias 0.6, Corr. Coeff. [r] = 0.946, # samples = 141, Unit (%) Glucose, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.461 + 1.034 * X, Bias -3.9, Corr. Coeff. [r] = 0.938, # samples = 134, Unit (mmol/L) Glucose, Comparison Instrument - Radiometer 725, Slope/Intercept - Y = -0.867 + 1.201 * X, Bias 5.2, Corr. Coeff. [r] = 0.986, # samples = 107, Unit (mmol/L) Urea, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.343 + 0.850 * X, Bias -10.8, Corr. Coeff. [r] = 0.957, # samples = 122, Unit (mmol/L) {8} Page 9 of 11 Urea, Comparison Instrument - Cobas Mira, Slope/Intercept - Y = -0.001 + 0.887 * X, Bias -11.1, Corr. Coeff. [r] = 0.981, # samples = 129, Unit (mmol/L) Lactate, Comparison Instrument - Omni Modular, Slope/Intercept - Y = -0.200 + 1.000 * X, Bias -9.5, Corr. Coeff. [r] = 0.936, # samples = 136, Unit (mmol/L) Lactate, Comparison Instrument - Cobas Mira, Slope/Intercept - Y = -0.297 + 1.074 * X, Bias -3.0, Corr. Coeff. [r] = 0.968, # samples = 137, Unit (mmol/L) b. Matrix comparison: The Omni S Analyzer utilizes the same sample types – whole blood, serum, plasma and aqueous material (QC material and dialysis fluids) as previously cleared on the predicate device, the Omni C analyzer (k013373) 3. Clinical studies: a. Clinical sensitivity: None stated b. Clinical specificity: None stated c. Other clinical supportive data (when a and b are not applicable): None 4. Clinical cut-off: None stated 5. Expected values/Reference range: A complete listing of critical values and expected values are provided in the technical manual of the Omni S. The values reflect normal or expected ranges including ranges for neonates, children and adults as needed. Additionally, explanations of typical disease states with each critical value for each assay is provided. These ranges and supportive documentation are derived from previously established literature. Specifically: "Critical Care Testing: A Quick Reference Guide" by Andrew St. John First edition 2001, Tietz "Textbook of Clinical Chemistry" third edition 1999, and "Labor und Diagnose" Lothar Thomas, fifth expanded edition 2000. M. Instrument Name: Roche Diagnostics Omni S Analyzer N. System Descriptions: 1. Modes of Operation: Routine, STAT 2. Software: The Roche Omni S utilizes a PC based interface to the user with a touch sensitive color matrix display and a barcode reader for input {9} Page 10 of 11 and display of data. Additional microcontrollers controls all operations of the Roche Omni S. Lower level tasks are done by a network of microcontrollers. The micro-controller network is responsible for data acquisition and sensor/actuator handling. The programming languages are standard for this type of task. FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types: Yes ☐ X or No ☐ 3. Sample Identification: Samples are identified via Bar Code or manual entry. 4. Specimen Sampling and Handling: Samples are a combination of whole blood, serum, plasma and aqueous solution (QC or dialysate). Samples are introduced via capillary tubes, syringes and sealed containers. 5. Assay Types: Ion selective Electrode, Enzymatic, MSS chamber sensors for BUN/urea nitrogen, for lactate and glucose the Omni S utilizes Braunstein technology. 6. Reaction Types: ISE, Enzymatic, MSS chamber sensors for BUN/urea nitrogen as the predicate devices. For lactate and glucose the Omni S utilizes Braunstein technology. 7. Calibration: The instrument automatically calibrates every 8, 12 or 24 hours (default) established by the user. This calibration includes: wavelength calibration of the polychromator, cleaning with internal cleaning solution, Automatic conditioning of the Na+ probe, Calibration of the mixing system and 2 point calibration of all parameters. Calibration of the O2 sensor is done every 30 minutes with ambient air and a zero point solution. O2 is recalibrated after every measurement. User can calibrate any parameter by performing a user activated calibration in the instrument software. Calibrators are sold separately. 8. Quality Control: Quality Control material is sold separately and consists of the following materials: Combitrol TS+ (k032453), Auto-trol+ (AutoQC material) (k032453), Combitrol Plus B and Auto-trol Plus B (AutoQC Material) (k032453). QC target ranges are included with each lot of QC material. Each analyte tested has three levels of QC range. QC timing is established by the user via the user interface. O. Other Supportive Instrument Performance Characteristics Data Not Covered In The "L. Performance Characteristics" Section Of The SE Determination Decision Summary. The Roche Diagnostics Omni S Analyzer performs the following assays: Potassium, Calcium, Sodium, {10} Page 11 of 11 Chloride, Blood Gases (PCO2, PO2) and pH, Hemoglobin, Hematocrit, Oxygen Saturation, Carboxyhemoglobin, Oxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Lactic Acid, Glucose, and Urea Nitrogen. Hemoglobin, Hematocrit, Deoxyhemoglobin, Carboxyhemoglobin, Oxyhemoglobin, Methemoglobin and Deoxyhemoglobin are regulated by the Office of InVitro Diagnostics Division of Hematology and Immunology. These assays were referred to the division for consultation. The results of that consultation are included with the review. P. Conclusion: Based upon the information provided, I recommend that the Roche Diagnostics Omni S Analyzer be found substantially equivalent to the respective predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K032311](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K032311) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com