SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM

{0} 1 of 10 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k061879 B. Purpose for Submission: New Instrument with ISE, demonstrating equivalence for use with cleared reagents for Glucose (k880236), and Blood Urea Nitrogen (BUN) (k880078) Repacked for use on Hemodiagnostica’s instruments. C. Measurand: Glucose BUN Sodium (Na⁺) Potassium (K⁺) Chloride (Cl⁻) D. Type of Test: Glucose and BUN-Quantitative Photometric Assays Na⁺, K⁺, and Cl⁻ Quantitative Ion Selective Electrode Assays E. Applicant: Hemodiagnostica, LLC F. Proprietary and Established Names: SDI CA480 Clinical Chemistry System G. Regulatory Information: 1. Regulation section: 21 CFR §862.1345-Glucose test system. 21 CFR §862.1770-Urea nitrogen test system. 21 CFR §862.1665-Sodium test system. 21 CFR §862.1600-Potassium test system. 21 CFR §862.1170-Chloride test system. 21 CFR §862.2160-Discrete Photometric Chemistry Analyzer for Clinical Use 2. Classification: II, II, II, II, II, I respectively 3. Product code: CFR-Hexokinase, Glucose CDN-Urease, Photometric, Urea Nitrogen JGS-Electrode, Ion Specific, Sodium CEM-Electrode, Ion Specific, Potassium CGZ-Electrode, Ion-Specific, Chloride JJE-Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 4. Panel: Chemistry (75) {1} 2 of 10 H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2. Indication(s) for use: The SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and are used in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: SDI CA480 Clinical Chemistry System I. Device Description: The SDI CA480 is a discrete, random access, microprocessor controlled photometric and ISE analyzer with the capability to perform 300 clinical chemistry tests per hour plus 180 electrolyte tests per hour for a total of 480 tests per hour. The product is for use in a clinical capacity as a tool for in vitro diagnostics. Glucose reagent Reactive Ingredients: G-6-PDH (L. mesenteroides), >1000 U/L; HK (yeast), >1000 U/L; ATP, 1.0 mmol/L; NAD, 1.5 mmol/L; 0.100 mol/L Tris buffer, pH 7.5 BUN Reagent Reactive Ingredients: R1: GLDH (bovine liver), >1000 U/L; α-KG, 7.0 mmol/L; Urease (jack bean), >30 KU/L; 0.06 mol/L tris buffer pH 7.8 R2: NADH (yeast), 3.2 mmol/L; buffer {2} $\mathrm{Na}^{+}$ , $\mathrm{K}^{+}$ , and CT ISE Module The integrated ISE module is included as a component to the SDI CA480. The ISE module being included has the capability to measure Sodium, Potassium and Chloride. The ISE module utilizes two positions on the sample wheel – a calibrant and a cleaning solution. The ISE module is connected by cable to the CPU of the SDI CA480. Commands to this module are handled by the software of the SDI CA480. # J. Substantial Equivalence Information: 1. Predicate device name(s): Model 550 Express, Ciba Corning Model 664/FAST 4 System 2. Predicate $510(\mathbf{k})$ number(s): k872302, k871028 respectively 3. Comparison with predicate: The SDI CA480 is substantially equivalent to the predicate devices, the Ciba Corning Model 550 Express (for photometric assays) and Ciba Corning Model 664/FAST 4 System (for ISE assays). | | SDI CA480 | Model 550 Express | | --- | --- | --- | | 510(K) # | New | k872302 | | System Principle | Discrete, random access, multi-test analysis | Discrete photometric clinical chemistry analyzer | | Throughput | 300 tests per hour | 180 test per hour | | Configuration | Analytical unit, Control Unit | Analytical Unit, Control Unit | | Optical Measurement Unit | | | | Measurement Modes | Absorbance | Absorbance | | Detector | Photo-diode | Photo-diode array | | Optical System | Wavelength range of 340 to 700 nm | Wavelength range of 340 to 600 nm | | Filters | 340,380,405,510,546,578,620, and 700 nm | 340, 380, 405, 510, 540, 570, and 600 nm | | Linear absorbance range | -.2 – 2.5 A at 340 nm | 0 – 2.5 A | | Light Source | 20 W Halogen lamp | 20 W Halogen Lamp | | Data Processing | | | | Calibration curve | Factor, Linear, Logit-log 1, Logit-log 2, Spline, Exponential, Polynomial | Factor, Linear, Qualitative, 1-Logit4, 2-Logit5, 3-Exponential 5, 4-Polynomial5 | | Cuvettes | Quartz non-disposable cuvettes | Disposable plastic cuvettes | | Number of cuvettes | 39 (washed between tests) | Rack loaded system | | Cuvette washing | Automatic washing system utilizing reagent grade water for washing and forced air / suction for drying | No cuvette washing system | | Path length | 7 mm | 10 mm | | Cuvette Volume | 600 μL | 450 μL | | Reagent Volume | 500 μL max | 400 μL max | {3} | | SDI CA480 | Model 550 Express | | --- | --- | --- | | 510(K) # | New | k872302 | | Sample/Reagent Delivery | | | | Pipetting System | Plunger driven by stepping motor | Motorized | | Sample Dispense | Sample volume: 3 – 50 μL; 1 μL step | Sample volume: 3 – 30 μL | | Reagent Dispense | Reagent 1 volume: 250 – 500 μL Reagent 2 volume: 1 – 250 μL 1 μL step | Reagent Volume: 50 – 400 μL | | | SDI CA480 | Model 664 | | --- | --- | --- | | 510(K) # | New | k871028 | | System Principle | Potentiometric | Potentiometric (for Na, Cl, and K), Thermal Conductivity (for CO2) | | Throughput | 180 test/hour | 270 test/hour (using ISE) | | Fluids measured | Whole Serum, Plasma, Diluted Urine | Serum, Plasma, Whole Blood, Urine | | Clinical Measurements | Sodium, Potassium, Chloride | Sodium, Potassium, Chloride, Bicarbonate | | Electrode Maintenance | disposable (no filling necessary) | Refillable electrode modules | | ISE Detector | Potentiometric | Potentiometric | | Modes of Analysis | Random Access or STAT | Programmable Batch or STAT | | Reagents / Calibrators | Provided Calibrant A and B | All Calibrant (All-Cal) | | Cleaning | Provided Cleaning Solution | Wash Solution | | Calibration Frequency | Every 30 minutes and by request. One point calibration done on every sample | Every 30 minutes or before a batch run | | Sample Volume | 60 μL, 160 μL for diluted urine (10:1) | 170 μL (batch and stat), 85 μL (microstat) | | Pipetting System | Probe driven by stepper motor | Motorized probe | | Fluid Verification | Optical fluid detection with bubble detection capability | Optical fluid detection | | Sample Dispensing | Aspiration and dispensation into ISE module | Aspiration from sample cup into fluidic/measurement system, no dispensing | # K. Standard/Guidance Document Referenced (if applicable): None referenced # L. Test Principle: Glucose Glucose in the serum sample is phosphorylated by hexokinase using excess adenosine triphosphate (ATP) in the presence of magnesium ions to glucose-6-phosphate. Glucose-6-phosphate is oxidized in the presence of nicotinamide adenine dinucleotide (NAD) by glucose-6-phosphate dehydrogenase (G-6-PDH) to 6-phosphogluconate and NADH which is measured at $340~\mathrm{nm}$ and is proportional to the amount of glucose present. {4} BUN Urea is converted to ammonia and $\mathrm{CO}_{2}$ by the enzyme urease. The ammonia produced is utilized by glutamate dehydrogenase (GLDH) to convert alpha-ketoglutarate ($\alpha$-KG) to glutamic acid, with the concomitant conversion of NADH to NAD which is measured at $340~\mathrm{nm}$, and is proportional to the amount of BUN present. Sodium, Potassium and Chloride The ISE Module of the SDI CA480 utilizes Ion Selective Electrode technology. The flow-through Sodium electrode uses selective membrane tubing, formulated to be sensitive to Sodium ions. The Potassium and Chloride electrodes employ similar designs with appropriate selective membrane materials. The potential of each electrode is measured relative to a fixed, stable voltage established by the double-junction silver / silver chloride reference electrode. An ion selective electrode develops a voltage that varies with the concentration of the ion to which it responds. The relationship between the voltage developed and the concentration of the sensed ion is logarithmic, as expressed by the Nernst equation: $$ \mathrm{Ex} = \mathrm{Es} + \frac{\mathrm{nF}}{\mathrm{RT}} \log(\mathrm{C}\alpha) $$ M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-Run and Total Precision studies were carried out two levels of sera were prepared based on medical decision levels. Within-run (Repeatability) data were generated according to CLSI procedure (EP-05) Glucose Precision: | Within Run n=40 | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | | Mean (mg/dL) | 50.5 | 112 | 296 | | S.D. (mg/dL) | 1.19 | 1.21 | 2.75 | | C.V. (%) | 2.36 | 1.08 | 0.93 | | Total | | | | | n=50 | (5 days / 2 runs per day / 5 samples per run) | | | | Mean (mg/dL) | 50.47 | 113.22 | 296.69 | | S.D. (mg/dL) | 1.45 | 1.01 | 2.14 | | C.V. (%) | 2.88 | 0.89 | 0.72 | BUN Precision: | Within Run n=20 | Level 1 | Level 2 | | --- | --- | --- | | Mean (mg/dL) | 10.3 | 19.95 | | S.D. (mg/dL) | 0.98 | 1.00 | | C.V. (%) | 9.50 | 5.01 | | Total | | | | n=50 | (5 days / 2 runs per day / 5 samples per run) | | | Mean (mg/dL) | 9.66 | 21.17 | | S.D. (mg/dL) | 0.79 | 1.19 | | C.V. (%) | 8.13 | 5.62 | | Sodium | Within-Run | | Total | | | --- | --- | --- | --- | --- | | | Level 1 | Level 2 | Level 1 | Level 2 | | | n = 20 | | n = 50 | | | Mean | 134.50 | 161.35 | 130.64 | 160.91 | | SD | 1.05 | 0.59 | 1.78 | 1.90 | | C.V | 0.78% | 0.36% | 1.37% | 1.18% | | (%) | | | | | | Range | 133 - | 160 - | 128.5- 135.5 | 156.5 - | | Potassium | Within-Run | | Total | | | --- | --- | --- | --- | --- | | | Level 1 | Level 2 | Level 1 | Level 2 | | | n = 20 | | n = 50 | | | Mean | 2.94 | 6.02 | 3.00 | 6.02 | | SD | 0.07 | 0.07 | 0.11 | 0.10 | | C.V (%) | 2.54% | 1.16% | 3.74% | 1.74% | | Range | 2.8 -3.1 | 5.9 - | 2.8 - 3.25 | 5.75 - | {5} 6 of 10 | | Within-Run | | Total | | | --- | --- | --- | --- | --- | | Chloride | Level 1 | Level 2 | Level 1 | Level 2 | | | n = 20 | | n = 50 | | | Mean | 74.85 | 110.75 | 74.82 | 111.88 | | SD | 1.27 | 1.45 | 1.10 | 1.36 | | C.V (%) | 1.69% | 1.31% | 1.47% | 1.22% | | Range | 73 - 77 | 109 - 115 | 72 - 77.5 | 108.5 - 114.5 | ## b. Linearity/assay reportable range: The measurement range for glucose is 3 to 550 mg/dL The measurement range for BUN is 4 mg/dL to 105 mg/dL. The measurement range for Sodium is 100 to 170 mmol/L The measurement range for Potassium is 2.0 to 7.0 mmol/L The measurement range for Chloride is 65 to 120 mmol/L The linearity study was performed according to CLSI guidance using commercially available linearity material | GLU | | Linearity Limit | | | 550 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | List No. | Published Values | Observed Values | | | Mean | | 2 * S.D. | Recovery | | | | Run 1 | Run 2 | Run 3 | Run 4 | | | | | 9201 | 25.0 | 27.0 | 26.0 | 26.0 | 28.0 | 26.75 | 1.91 | 107.00% | | 9202 | 200.0 | 203.0 | 202.0 | 204.0 | 203.0 | 203.00 | 1.63 | 101.50% | | 9203 | 375.0 | 379.0 | 378.0 | 380.0 | 379.0 | 379.00 | 1.63 | 101.07% | | 9204 | 550.0 | 561.0 | 560.0 | 560.0 | 562.0 | 560.75 | 1.91 | 101.95% | | 9205 | 725.0 | 742.0 | 745.0 | 744.0 | 745.0 | 744.00 | 2.83 | 102.62% | | | | | | | | Avg. Recovery | | 102.83% | | BUN | | Linearity Limit | | | 105 | | | | | No. | Published Values | Observed Values | | | Mean | | 2 * S.D. | Recovery | | | | Run 1 | Run 2 | Run 3 | Run 4 | | | | | 9201 | 5.0 | 5.0 | 5.0 | 4.0 | 5.0 | 4.75 | 1.00 | 95.00% | | 9202 | 37.5 | 37.0 | 38.0 | 38.0 | 38.0 | 37.75 | 1.00 | 100.67% | | 9203 | 70.0 | 71.0 | 72.0 | 72.0 | 73.0 | 70.00 | 1.63 | 100.00% | | 9204 | 102.5 | 104.0 | 103.0 | 105.0 | 104.0 | 104.00 | 1.63 | 101.46% | | 9205 | 135.0 | 138.0 | 136.0 | 138.0 | 138.0 | 137.50 | 2.00 | 101.85% | | | | | | | | Avg. Recovery | | 99.80% | {6} 7 of 10 | Sodium | | Linearity Limit | | | 160 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | List No. | Published Values | Observed Values | | | | Mean | 2 S.D. | Recovery | | | | Run 1 | Run 2 | Run 3 | Run 4 | | | | | 9201 | 100 | 104 | 103 | 104 | 104 | 103.75 | 1.00 | 103.75% | | 9202 | 118 | 120 | 120 | 121 | 118 | 119.75 | 2.52 | 101.48% | | 9203 | 136 | 138 | 138 | 138 | 138 | 138.00 | 0.00 | 101.47% | | 9204 | 154 | 151 | 156 | 156 | 156 | 154.75 | 5.00 | 100.49% | | 9205 | 172 | 174 | 173 | 173 | 171 | 172.75 | 2.52 | 100.44% | | | | | | | | Avg. Recovery | | 101.53% | | | Potassium | Linearity Limit | | | 6.5 | | | | | List No. | Published Values | Observed Values | | | | Mean | 2 S.D. | Recovery | | | | Run 1 | Run 2 | Run 3 | Run 4 | | | | | 9201 | 1.75 | 1.80 | 2.00 | 1.80 | 1.90 | 1.88 | 0.19 | 107.14% | | 9202 | 4.50 | 4.30 | 4.30 | 4.40 | 4.50 | 4.38 | 0.19 | 97.22% | | 9203 | 7.25 | 6.90 | 7.10 | 7.00 | 7.30 | 7.08 | 0.34 | 97.59% | | 9204 | 10.00 | 9.70 | 9.90 | 9.80 | 10.00 | 9.85 | 0.26 | 98.50% | | 9205 | 12.75 | 12.50 | 12.60 | 12.60 | 12.50 | 12.55 | 0.12 | 98.43% | | | | | | | Avg. Recovery | | | 99.78% | | | Chloride | Linearity Limit | | | 120 | | | | | List No. | Published Values | Observed Values | | | | Mean | 2 S.D. | Recovery | | | | Run 1 | Run 2 | Run 3 | Run 4 | | | | | 9201 | 60.0 | 60.0 | 62.0 | 61.0 | 62.0 | 61.25 | 1.91 | 102.08% | | 9202 | 88.5 | 89.0 | 90.0 | 90.0 | 90.0 | 89.75 | 1.00 | 101.41% | | 9203 | 117.0 | 118.0 | 118.0 | 119.0 | 120.0 | 118.75 | 1.91 | 101.50% | | 9204 | 145.5 | 145.0 | 144.0 | 145.0 | 145.0 | 144.75 | 1.00 | 99.48% | | 9205 | 174.0 | 177.0 | 175.0 | 176.0 | 175.0 | 175.75 | 1.91 | 101.01% | | | | | | | Avg. Recovery | | | 101.10% | c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability information for the assays was reviewed under k880236 for Glucose, k880078 for BUN and k000926 for Sodium, Potassium and Chloride. d. Detection limit: Glucose A calibration factor of approximately 750 was obtained, which is equivalent to {7} an analytical sensitivity of 1.33 $\Delta$mAbs per mg/dL. ## Limit of Detection: 10 samples containing no analyte were measured and the LoD calculated. The Limit of Detection for Glucose was found to be 3 mg/dL. ## Limit of Quantitation: 40 samples containing known low amount of analyte were measured. Precision was evaluated, with a maximum C.V. (%) of 20% allowed. The Limit of Quantitation for Glucose was found to be 3 mg/dL. ## BUN A calibration factor of approximately 796 was obtained, which is equivalent to a sensitivity of 1.26 $\Delta$mAbs per mg/dL. ## Limit of Detection: 10 samples containing no analyte were measured and the LoD calculated. The Limit of Detection for BUN was found to be 4 mg/dL. ## Limit of Quantitation: 40 samples containing known low amount of analyte were measured. Precision was evaluated, with a maximum C.V. (%) of 20% allowed. The Limit of Quantitation for BUN was found to be 4 mg/dL. ## ISE The calibration factor for each assay is 1000, which gives a sensitivity of 1.00 $\Delta$mAbs per mmol/dL. The ISE measurable range is based on linearity studies only. ## e. Analytical specificity: ### Glucose **Hemoglobin:** Hemolyzed sample (>200 mg/dL hemoglobin) will interfere with this assay. **Bilirubin:** No significant interference (±10%) from bilirubin up to 6.0 mg/dL. **Lipemia:** Lipemic samples (>275 mg/dL) measured as triglycerides will interfere with this assay. ### BUN **Hemoglobin:** No significant interference (±10%) from hemoglobin up to 200 mg/dL. **Bilirubin:** Samples with high Bilirubin (>3.5 mg/dL) will interfere with this assay. **Lipemia:** 8 of 10 {8} No significant interference $(\pm 10\%)$ from triglyceride up to $250~\mathrm{mg/dL}$. ISE Hemoglobin: Hemoglobin shows interference with potassium. Do not use hemolyzed samples for potassium. No significant interference from hemoglobin on sodium and chloride up to $2000\mathrm{mg/dL}$. Lipemia: No significant interference from lipemia up to $1000\mathrm{mg/dL}$ measured as triglycerides on sodium, potassium or chloride. Bilirubin: No significant interference from Bilirubin up to $31\mathrm{mg/dL}$ on sodium, potassium or chloride. For a comprehensive review of drug interference see Young, et al$^{1}$. f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: A method comparison was performed between the SDI CA480 and the predicate Ciba Corning Express 550 (for BUN and Glucose) and Ciba Corning 664 (for Na, K, and Cl) according to CLSI protocols across the claimed assay ranges. Linear regression results are summarized below: | Analyte | n | r | y = | Range | | --- | --- | --- | --- | --- | | BUN | 60 | 0.9988 | y = 0.933x + 0.94 | 4 - 105 | | Glucose | 67 | 0.9998 | y = 0.981x + 0.99 | 4 - 559 | | Sodium | 60 | 0.9905 | y = 0.998x -1.26 | 86 - 173 | | Potassium | 60 | 0.9946 | y = 0.977x + 0.06 | 1.6 - 7.1 | | Chloride | 60 | 0.9761 | y = 1.019x -2.34 | 64 - 125 | 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 $^{1}$ Young, D.S., et al, Clin. Chem. 21:1D (1975) {9} 5. Expected values/Reference range: Glucose: 70 - 105 mg/dL BUN: 7 - 18 mg/dL Sodium: 136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L References from Tietz, N.W., Fundamentals of Clinical Chemistry, 2nd ed., .B. Saunders Co., Philadelphia, p. 2190, (1994) N. Instrument Name: Hemodiagnostica, SDI CA480 Chemistry Analyzer O. System Descriptions: 1. Modes of Operation: Random Access or STAT modes 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X or No ☐ 3. Specimen Identification: Manual entry, Worklist downloads and Bar Code 4. Specimen Sampling and Handling: Direct primary tube sampling or sample cups 5. Calibration: Photometric Calibration curves: Factor, Linear, Logit-log 1, Logit-log 2, Spline, Exponential, and Polynomial ISE Potentiometric Calibrant A and B, every 30 minutes and by request. One point calibration done on every sample. 6. Quality Control: Analyzer has a Quality Control program to monitor assay trends. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: None Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 10 of 10