SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

{0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171476 B. Purpose for Submission: New Device C. Measurand: Sodium, Potassium, Chloride D. Type of Test: Quantitative, ion selective electrode technology E. Applicant: Awareness Technology, Inc. F. Proprietary and Established Names: SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JGS | Class II | 21 CFR 862.1665 Sodium Test System | Clinical Chemistry (75) | | CEM | | 21 CFR 862.1600 Potassium Test System | | | CGZ | | 21 CFR 862.1170 Chloride Test System | | | JJE | Class I | 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry for Clinical Use | | H. Intended Use: 1. Intended use(s): See Indications for use below {1} 2. Indication(s) for use: The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in-vitro diagnostic use only. The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. 3. Special conditions for use statement(s): For in-vitro diagnostic use only For prescription use only Not for Point-of-Care Use 4. Special instrument requirements: SelectaLyte Electrolyte Analyzer, model #3910 I. Device Description: The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum, and lithium heparin venous whole blood. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen. The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. Each reagent pack contains the following reagents: - Cal Standard: 650mL (Na+ 150 mmol/L, K+ 5.0 mmol/L, Cl- 115 mmol/L) - SLOPE Standard: 125mL (Na+ 100 mmol/L, K+ 2.0 mmol/L, Cl- 70 mmol/L) - Reference Solution: 125 mL (KCl: 1.2 mol/L) {2} J. Substantial Equivalence Information: 1. Predicate device name(s): AVL 9180 Electrolyte Analyzer 2. Predicate 510(k) number(s): k961458 3. Comparison with predicate: | Similarities and Differences | | | | --- | --- | --- | | Item | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (Candidate Device k171476) | AVL 9180 Electrolyte Analyzer (Predicate Device k961458) | | Intended Use | For in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride. | Same | | Method Principle | Ion Selective Electrode with potentiometric method | Same | | Standardization | Na: Flame photometric with NIST reference standards K: Flame photometric method with NIST reference serum Cl: Coulometric method with NIST standards | Same | | Analytical Measuring Range: | Na: 40 – 205 mmol/L K: 1.5 – 15.0 mmol/L Cl: 50 – 200 mmol/L | Same | | Sample Type | whole blood, serum | whole blood, serum or plasma, urine | | Electrolytes Measured | Sodium (Na+), Potassium (K+), and Chloride (Cl-) | Sodium (Na+), Potassium (K+), Chloride (Cl-), Lithium(Li+), Calcium(Ca2+) | | Sample Volume | 85 μL | 95 μL | | Reagent Pack | Cal Standard: 650mL SLOPE Standard: 125mL Reference solution: 125 mL Waste bag | Standard A 350 mL Standard B 85 mL Reference Solution 85 mL Waste bag | K. Standard/Guidance Document Referenced (if applicable): - CLSI EP05-A2: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. {3} - CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. - CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline. - CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline. - CLSI EP 21-A: Evaluation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline. - CLSI GP 41-A6: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved standard. # L. Test Principle: The SelectaLyte Electrolyte Analyzer $(\mathrm{Na}^{+},\mathrm{K}^{+},\mathrm{Cl}^{-})$ measures sodium, potassium, and chloride in dialysate using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium electrode incorporates neutral carrier ionophore membranes which are highly selective for their respective ions. The chloride electrode contains an ionophore covalently bound to a substrate which is sensitive to negatively charged ions. The potential of each electrode is measured relative to a fixed, stable reference established by a silver/silver chloride electrode in concentrated salt solution. The measured potential varies with the concentration of the ion sensed by the electrode. # M. Performance Characteristics (if/when applicable): # 1. Analytical performance: # a. Precision/Reproducibility: Precision testing was performed in accordance with CLSI EP05-A2 guideline. Serum sample precision was evaluated by testing three levels of serum pools in two replicates per run, two runs per day for 20 days on two instruments by multiple operators. Whole blood sample precision was evaluated by testing three levels of whole blood samples on two instruments with calibrations after 10 consecutive replicates to obtain a total of 40 results per sample. The data obtained from two instruments are very similar and a representative data set is shown in the tables below: Precision results for Sodium Matrix: Serum | Sample | N | Mean (mmol/L) | Within Run | | Within Lab | | | --- | --- | --- | --- | --- | --- | --- | | | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | | Serum 1 | 80 | 95.2 | 0.27 | 0.29% | 0.78 | 0.82% | | Serum 2 | 80 | 134.7 | 0.33 | 0.25% | 0.72 | 0.54% | | Serum 3 | 80 | 178.8 | 0.28 | 0.16% | 1.51 | 0.84% | {4} Precision results for Potassium Matrix: Serum | Sample | N | Mean (mmol/L) | Within Run | | Within Lab | | | --- | --- | --- | --- | --- | --- | --- | | | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | | Serum 1 | 80 | 2.77 | 0.02 | 0.64% | 0.02 | 0.79% | | Serum 2 | 80 | 4.01 | 0.02 | 0.52% | 0.03 | 0.78% | | Serum 3 | 80 | 6.59 | 0.02 | 0.24% | 0.06 | 0.97% | Precision results for Chloride Matrix: Serum | Sample | N | Mean (mmol/L) | Within Run | | Within Lab | | | --- | --- | --- | --- | --- | --- | --- | | | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | | Serum 1 | 80 | 63.2 | 0.29 | 0.46% | 0.58 | 0.91% | | Serum 2 | 80 | 90.1 | 0.31 | 0.34% | 0.74 | 0.82% | | Serum 3 | 80 | 114.4 | 0.3 | 0.26% | 1.06 | 0.93% | Precision results for Sodium Matrix: Whole Blood | Sample | N | Mean (mmol/L) | Within Run | | Within Lab | | | --- | --- | --- | --- | --- | --- | --- | | | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | | Whole blood 1 | 40 | 98.9 | 0.69 | 0.70% | 0.42 | 0.43% | | Whole blood 2 | 40 | 136.8 | 0.58 | 0.42% | 0.32 | 0.24% | | Whole blood 3 | 40 | 161.0 | 0.35 | 0.22% | 0.23 | 0.14% | Precision results for Potassium Matrix: Whole Blood | Sample | N | Mean (mmol/L) | Within Run | | Within Lab | | | --- | --- | --- | --- | --- | --- | --- | | | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | | Whole blood 1 | 40 | 2.14 | 0.03 | 1.33% | 0.03 | 1.27% | | Whole blood 2 | 40 | 3.29 | 0.07 | 2.03% | 0.07 | 2.07% | | Whole blood 3 | 40 | 7.78 | 0.06 | 0.79% | 0.08 | 1.07% | Precision results for Chloride Matrix: Whole Blood | Sample | N | Mean (mmol/L) | Within Run | | Within Lab | | | --- | --- | --- | --- | --- | --- | --- | | | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | | Whole blood 1 | 40 | 69.5 | 0.88 | 1.26% | 0.57 | 0.81% | | Whole blood 2 | 40 | 104.4 | 0.95 | 0.91% | 0.52 | 0.50% | | Whole blood 3 | 40 | 129.9 | 0.7 | 0.54% | 0.53 | 0.40% | b. Linearity/assay reportable range: The linearity studies were performed following the CLSI EP06-A guideline. For the three electrolytes, ten to eleven equally spaced concentrations covering the measurement range were prepared by mixing high and low concentration samples. {5} Four replicates were measured for each sample. The observed values were plotted against the expected values and linear regression analysis was performed. The summary results are provided in the table below. | Analyte in Serum | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | r | | --- | --- | --- | --- | --- | --- | | Sodium | 40 to 205 | 35.9 - 203.5 | 0.988 | -3.81 | 0.9988 | | Potassium | 1.5 to 15.0 | 1.26 - 19.62 | 1.010 | -0.14 | 0.9999 | | Chloride | 50 to 200 | 30.1 - 202.3 | 0.999 | -1.32 | 0.9999 | | Analyte in Whole Blood | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | r | | Sodium | 40 to 205 | 33 - 217.5 | 1.006 | -4.28 | 0.9995 | | Potassium | 1.5 to 15.0 | 1.45 - 18.49 | 1.008 | -0.41 | 0.9993 | | Chloride | 50 to 200 | 33.4 - 214.6 | 1.000 | 0.35 | 1.0000 | The results of the linearity study support the sponsor's claimed measuring ranges (as described in the table above). c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The SelectaLyte Na assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST). The SelectaLyte K assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the NIST. The SelectaLyte Cl assay is traceable to a coulometric reference method, which uses reference materials from the NIST. d. Detection limit: Reportable ranges were determined based on the linearity studies (see above, M.1.b). e. Analytical specificity: Interference studies were performed according to CLSI EP07-A2 guideline to determine the effects from potential interferents on the ISE assays. Various concentrations of interferents were spiked into two levels (low and high) of each analyte in serum or whole blood. Testing was performed in four replicates per level using one reagent lot on one instrument. The sponsor states that interference is considered to be non-significant if the bias between the tested and control samples are within 4.0, 0.20 and $3.1\mathrm{mmol / L}$ for $\mathrm{Na^{+}}$, $\mathrm{K^{+}}$ and $\mathrm{Cl^{-}}$, respectively. {6} The results of the interference study for serum samples are summarized below: | Analyte | Interferent | Highest concentration tested that did not show significant interference | | --- | --- | --- | | Serum Sodium | Bilirubin Conjugate | 1000.0 mg/dL | | | Cholesterol | 503.1 mg/dL | | | Hemoglobin | 200.0 mg/dL | | | Isoniazid | 4.0 mg/dL | | | Lithium Acetate | 21.1 mg/dL | | | Magnesium Acetate | 213.6 mg/dL | | | Metronidazole | 12.0 mg/dL | | Serum Potassium | Bilirubin Conjugate | 1000.0 mg/dL | | | Cholesterol | 503.1 mg/dL | | | Hemoglobin | 200.0 mg/dL | | | Isoniazid | 4.0 mg/dL | | | Lithium Acetate | 21.1 mg/dL | | | Magnesium Acetate | 213.6 mg/dL | | | Metronidazole | 12.0 mg/dL | | | Sodium Fluoride | 0.33 mg/dL | | | Sodium Heparin | 3000.0 U/L | | | Sodium Iodide* | 5.6 mg/dL | | | Triglycerides | 2364.3 mg/dL | | | Vancomycin | 10.3 mg/dL | | Serum Chloride | Acetylcysteine | 166.5 mg/dL | | | Acetylsalicylic Acid | 65.2 mg/dL | | | Ampicillin | 5.3 mg/dL | | | Bilirubin Conjugate | 1000.0 mg/dL | | | Cefoxitin | 69.5 mg/dL | | | Cholesterol | 200.0 mg/dL | | | Doxycycline | 3.2 mg/dL | | | EDTA | 0.13 mg/dL | | | Hemoglobin | 200.0 mg/dL | | | Ibuprofen | 55.4 mg/dL | | | Isoniazid | 4.0 mg/dL | | | Lithium Acetate | 21.1 mg/dL | | | Magnesium Acetate | 213.6 mg/dL | | | Metronidazole | 12.0 mg/dL | | | Paracetamol | 20.0 mg/dL | | | pH (High) | ~8.0 | | | Potassium Thiocyanate | 25.1 mg/dL | | | Rifampicin | 6.4 mg/dL | | | Sodium Bicarbonate | 294.0 mg/dL | | | Sodium Bromide* | 24.1 mg/dL | | | Sodium Fluoride | 0.33 mg/dL | | | Sodium Heparin | 3000.0 U/L | {7} 8 | Analyte | Interferent | Highest concentration tested that did not show significant interference | | --- | --- | --- | | | Sodium Iodide | 5.6 mg/dL | | | Triglycerides | 2364.3 mg/dL | | | Vancomycin | 10.3 mg/dL | *Continued Interference Serum Interference Observations: - Cholesterol showed interference with Chloride assay at concentrations 503 mg/dL, 377 mg/dL, 251 mg/dL with a bias greater than 3.4 mmol/L. - Potassium Thiocyanate showed interference with Chloride assay at concentrations 66.9 mg/dL, 33.4 mg/dL, with a bias greater than 4.3 mmol/L. - Sodium Bromide showed interference with Chloride assay at all concentrations tested with a bias greater than 4.5 mmol/L. - Sodium Fluoride showed interference with Chloride and Potassium assays at concentration 0.44 mg/dL with a bias of 12.4 mmol/L for chloride and 0.64 mmol/L for potassium. - Sodium Iodide showed interference with Chloride and Potassium assays at concentration 44.8 mg/dL, 22.5 mg/dL, 11.2 mg/dL, with a bias of 3.3 mmol/L for chloride and continued interference for potassium with a bias greater than 0.24 mmol/L. The interference study for whole blood samples are summarized below: | Analyte | Interferent | Highest concentration tested that did not show significant interference | | --- | --- | --- | | Whole Blood Sodium | Acetone | 69.7 mg/dL | | | Acetylsalicylic Acid | 59.1 mg/dL | | | Benzalkonium Chloride | 0.67 mg/dL | | | Bilirubin Conjugate | 1000.0 mg/dL | | | Bilirubin, Total | 20.0 mg/dL | | | Cholesterol | 503.1 mg/dL | | | Creatinine | 5.0 mg/dL | | | Ethanol | 399.9 mg/dL | | | Hemoglobin | 200.0 mg/dL | | | Potassium Thiocyanate | 66.9 mg/dL | | | Salicylic Acid | 59.9 mg/dL | | Whole Blood Potassium | Acetone | 69.7 mg/dL | | | Acetylsalicylic Acid | 59.1 mg/dL | | | Bilirubin Conjugate | 1000.0 mg/dL | | | Bilirubin, Total | 10.0 mg/dL | | | Cholesterol | 503.1 mg/dL | | | Creatinine | 5.0 mg/dL | | | Ethanol | 399.9 mg/dL | {8} | Analyte | Interferent | Highest concentration tested that did not show significant interference | | --- | --- | --- | | | Hemoglobin | 150.0 mg/dL | | | Salicylic Acid | 15.0 mg/dL | | | Sodium Bromide | 48.2 mg/dL | | Whole Blood Chloride | Acetone | 69.7 mg/dL | | | Acetylsalicylic Acid | 59.1 mg/dL | | | Bilirubin Conjugate | 1000.0 mg/dL | | | Bilirubin, Total | 20.0 mg/dL | | | Cholesterol | 251.6 mg/dL | | | Creatinine | 5.0 mg/dL | | | Ethanol | 399.9 mg/dL | | | Hemoglobin | 200.0 mg/dL | | | Potassium Thiocyanate* | 8.4 mg/dL | | | Salicylic Acid | 45.0 mg/dL | | | Sodium Bromide* | 24.1 mg/dL | | | Sodium Iodide | 11.3 mg/dL | *Continued Interference Whole Blood Interference Observations: - Bilirubin, Total showed interference with Potassium assay at concentrations 20 mg/dL, 15 mg/dL, with a bias greater than 0.22 mmol/L. - Cholesterol showed interference with Chloride assay at concentrations 503 mg/dL, 377 mg/dL, with a bias greater than 3.6 mmol/L. - Hemoglobin showed interference with Potassium assay at concentrations 200 mg/dL, 377 mg/dL, 251 mg/dL with a bias greater than 0.27 mmol/L. - Potassium Thiocyanate showed interference with Chloride assay at all concentrations tested with a bias greater than 4.7 mmol/L. - Salicylic Acid showed interference with Chloride assay at concentration 60 mg/dL with a bias greater than 8.5 and Potassium assay at concentrations 60 mg/dL, 45 mg/dL, 29 mg/dL, 22.5 mg/dL with a bias greater than 0.24 mmol/L. - Sodium Bromide showed interference with Chloride assay at all concentrations tested with a bias greater than 22.1 and Potassium assay at concentrations 386 mg/dL, 193 mg/dL, 93.5 mg/dL, 22.5 mg/dL with a bias greater than 0.32 mmol/L. - Sodium Iodide showed interference with Chloride assay at concentration 44.8 mg/dL with a bias of 8.2 mmol/L. - Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium. f. Assay cut-off: Not Applicable {9} 10 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were performed following CLSI EP09-A3. One hundred patient samples for each sample matrix type were run in singlet on one SelectaLyte Electrolyte Analyzer and the results were compared to those obtained on the predicate device (AVL 9180 Electrolyte Analyzer). Among the samples tested for each analyte, 10% of the samples were spiked or diluted to fully span the claimed measuring range of each analyte. The ordinary linear regression analyses for the three electrolytes are summarized below: | Analyte in Serum | Slope | Intercept | r² | N | Range tested (mmol/L) | | --- | --- | --- | --- | --- | --- | | Sodium | 0.971 | 2.79 | 0.9869 | 100 | 43.3-194.2 | | Potassium | 1.014 | -0.17 | 0.9959 | 100 | 1.51-14.72 | | Chloride | 0.950 | 6.14 | 0.9854 | 100 | 55-192.6 | | Analyte in Whole Blood | Slope | Intercept | r² | N | Range tested (mmol/L) | | Sodium | 1.002 | -1.60 | 0.9865 | 100 | 43.3-204.6 | | Potassium | 1.028 | -0.21 | 0.9946 | 100 | 1.58-14.84 | | Chloride | 0.953 | 4.92 | 0.9806 | 100 | 53-192.2 | 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 {10} 5. Expected values/Reference range: Reference ranges of Na⁺, K⁺, and Cl⁻ are cited from literature¹: Sodium: 136 – 145 mmol/L Potassium: 3.5 – 5.0 mmol/L Chloride: 98 – 106 mmol/L ¹Mosby's Diagnostic and Laboratory Test Reference 8ed. 2017 N. Instrument Name: SelectaLyte Electrolyte Analyzer (Na⁺, K⁺, Cl⁻), model #3910 O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ☐ or No ☑ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ☐ or No ☑ 2. Software: The software for the SelectaLyte Electrolyte Analyzer system is determined to have a moderate level of concern. FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☑ or No ☐ 3. Specimen Identification: Manual entry 4. Specimen Sampling and Handling: A sample probe in the SelectaLyte Electrolyte Analyzer aspirates 85 μL samples directly from sample tubes. 11 {11} 5. Calibration: The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) performs a 2-point calibration every 4 hours or by request with a known fluid from the SelectaLyte Reagent Pack. A 1-point calibration is performed automatically during each measurement. 6. Quality Control: The sponsor recommends on their labeling that “Use only Selectalyte Quality Control Kit Tri Level for monitoring performance.” and “Follow government regulations or accreditation requirements for quality control frequency. At least once each day of use, analyze 2 levels (low and high) of commercially available quality control (QC) material with known Na, K, Cl concentrations.” P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable 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.