CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k133519 B. Purpose for Submission: New device C. Measurand: Sodium, Potassium, Chloride, and Glucose D. Type of Test: Quantitative, Photometric and Ion Selective Electrode E. Applicant: Carolina Liquid Chemistries, Corp. F. Proprietary and Established Names: Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer Carolina Liquid Chemistries Glucose Reagent Carolina Liquid Chemistries ISE Calibrator Kit Carolina Liquid Chemistries ISE Kit G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JJE | I | 862.2160, analyzer, chemistry (photometric, discrete) for clinical use | 75-Chemistry | | JGS | II | 862.1665, Sodium Test System | 75-Chemistry | | CEM | II | 862.1600, Potassium Test System | 75-Chemistry | | CGZ | II | 862.1170, Chloride Test System | 75-Chemistry | | CFR | II | 862.1345, Glucose Test System | 75-Chemistry | | JIX | II | 862.1150, Calibrators | 75- Chemistry | {1} H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples. Carolina Liquid Chemistries Glucose Reagent The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma. Carolina Liquid Chemistries ISE Kit The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders. Carolina Liquid Chemistries ISE Calibrator Kit The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1, Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays. For in vitro diagnostic use only. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer {2} I. Device Description: Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer The Carolina Liquid Chemistries CLC 6410 is an automated clinical analyzer for in vitro diagnostic use in clinical laboratories. It is designed for in vitro quantitative determination of general clinical chemistries in serum and plasma samples. The device consists of the software, a carousel system for both reagents and samples, an internal cooling unit, a sampling/dispensing arm assembly, an incubation assembly, and a wash station. The CLC 6410 also includes an ISE Module. The ISE module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode, and accessory reagents available in the ISE Kit (ISE Buffer, ISE Internal Reference, and ISE Reference Solution). Carolina Liquid Chemistries Glucose Reagent The Carolina Liquid Chemistries Glucose reagent is ready to use. The composition of the Carolina Liquid Chemistries Glucose Hexokinase Reagent is as follows: G-6-PD (L. mesenteroides), 17000 U/L; Hexokinase (yeast), 850 U/L; ATP, 1.0 mmol/L: NAD, 1.5 mmol/L. Carolina Liquid Chemistries ISE Kit ISE kit contains the following ingredients: ISE Buffer: Tris ISE internal reference solution: Tris, Sodium Chloride, Potassium Chloride, and Calcium Chloride ISE Reference solution: Tris, Sodium Chloride, Potassium Chloride, and Calcium Chloride Carolina Liquid Chemistries ISE Calibrator Kit The ISE Calibrator Kit consists of two calibrator levels (level 1 and 2) and a Selectivity Check (Quality Control for the Calibration) with the following ingredients, respectively: Calibrator 1: Sodium Chloride, Potassium Dihydrogen Phosphate, and Sodium Bicarbonate Calibrator 2: Sodium Chloride, Potassium Dihydrogen Phosphate, and Sodium Bicarbonate Selectivity Check: Freeze-dried powder: Sodium Chloride, Potassium Dihydrogen Phosphate, Sodium Bicarbonate; Dissolved liquid: Albumin. Calibrator 1 and 2 are supplied ready for use. The Selectivity Check components require preparation. J. Substantial Equivalence Information: 1. Predicate device name(s): Olympus AU 400 Clinical Chemistry Analyzer Derma Media Lab Glucose Reagent Phoenix ISE Reagents for Olympus AU Series {3} 2. Predicate 510(k) number(s): K981743 K970664 K020148 3. Comparison to predicate Instrument comparison: | Items | Candidate Device: Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer | Predicate Device: Olympus AU 400 Clinical Chemistry Analyzer (K981743) | | --- | --- | --- | | Similarity/Difference | | | | Intended Use | For the quantitative measurements of Glucose, Na+ (Sodium), K+ (Potassium), and Cl- (Chloride) in serum and plasma samples. | Same | | Setting | Clinical laboratory use only | Same | | Power | 220V 50 Hz | AC 208 V 50/60 Hz | | Analytical Methods | Endpoint, fixed-time, kinetic | Same | | Calibration Methods | Linear calibration and nonlinear calibration | Same | | Throughput (Max) | 1600 photometric tests per hour; 1800 tests/hour with integrated ISE; 2200 or 2800 tests/hour with independent ISEs | Maximum 400 (800 including ISE) tests per hour; 200 samples/hour analyzing only ISE | | Calibration / QC | Automatic and Manual calibration / QC | Same | | Bar code | Yes | Optional | | Photometer wave length | 340-800 (13 wavelengths) | Same | | Linear Absorbance Range | 0-3.3 Absorbance | 0-3 Absorbance | | Reaction Cuvettes | Reusable rigid optical plastic cuvette | Square, glass cuvette | | Reaction Volume | 150-450 μl | 90-350 μl | | Sample type | Serum and plasma | Serum | {4} ISE reagent kit comparison: | Items | Candidate Device: Carolina Liquid Chemistries ISE Kit | Predicate Device: Phoenix ISE Reagents for Olympus AU Series (K020148) | | --- | --- | --- | | Similarity/Difference | | | | Intended Use | For the quantitative measurements of sodium, potassium and chloride in serum and plasma. | Same | | Sample size | 45ul | 20ul | | Measuring range | Na = 102 to 173 K = 3 to 10 Cl = 70 to 150 | Na = 100 to 180 K = 3 to 10 Cl = 70 to 150 | | Reagent Stability | Unopened: Unopened ISE Buffer, ISE Internal Reference Solution and ISE Reference Solution are stable until expiry date when stored at 10-30°C. On board, the reagents are stable for 12 days. | Unopened: date of expiry at 2-25°C. Internal Reference is stored at 15-25°C. Buffer and Reference solutions are stable for 90 days when opened and stored in the ISE compartment of the analyzer. After opening, Internal Reference Solution may be stored at 15-25 °C for up to 90 days. | ISE calibrator kit comparison: | Items | Candidate Device: Carolina Liquid Chemistries ISE Calibrator Kit | Predicate Device: Phoenix ISE Reagents for Olympus AU Series (K020148) | | --- | --- | --- | | Similarity/Difference | | | | Intended Use | For the calibration of sodium, potassium and chloride. | Same | | Calibrator Stability | Unopened calibrators and selectivity check are stable until expiration date when stored at 2-8°C. Once opened, Calibrator 1 and Calibrator 2 are stable for 12 days when stored at 2-8°C. The Selectivity Check is stable for 5 days when stored at 2-8°C. | Unopened calibrators and selectivity check are stable until expiry date when stored at 2-25°C. After opening, the Low serum standard, High serum standard, and the Na+/K+ | {5} 6 | | | Selectivity Check may be stored at 2-25°C for up to 90 days, provided the cap is replaced immediately after each use. | | --- | --- | --- | | Calibrator levels | 2-point; Calibrator 1 (low), Calibrator 2 (high) Selectivity Check (QC) | Same | Glucose reagent comparison: | Items | Candidate Device: Carolina Liquid Chemistries Glucose Reagent | Predicate Device: Derma Media Glucose Reagent (K970664) | | --- | --- | --- | | Similarity/Difference | | | | Intended Use | For the quantitative measurement of glucose in serum and plasma. | Same | | Test Principle | Hexokinase | Same | | Sample Type | Serum and Plasma | Serum | | Measuring range | 13 to 700 mg/dL | Same | # K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Statistical Approach; Approved Guideline CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition CLSI EP9-A2-IR: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition CLSI EP10-A2: Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures – Second Edition. CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline {6} L. Test Principle: Glucose measurement is based on the hexokinase method. Glucose is phosphorylated by hexokinase and 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 nm and is proportional to the amount of glucose present in the sample. Electrolytes (sodium, potassium, and chloride) are measured based on ion selective electrodes principles. The Carolina Liquid Chemistries ISE module employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. An electrical potential is developed according the Nernst Equation for a specific ion. When compared to a reference, this electrical potential is translated into voltage and then into the ion concentration of the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run precision was evaluated using four levels of serum based controls (commercially available) and tested in one run with 20 replicates. Total precision was evaluated over a total of twenty days, 20 replicates per run and two separate runs per day for a total of 800 measurements. Within-run and total precision results are summarized in the below tables. Precision Performance: Glucose Serum Measurements (mg/dL) | Analyte | | Within Run | | | Total Precision | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Glucose | Sample | Mean | SD | %CV | Mean | SD | %CV | | | Control 1 | 66.2 | 0.77 | 1.2 | 66.4 | 1.7 | 2.6 | | | Control 2 | 99.4 | 1.02 | 1.0 | 102.7 | 3.46 | 3.4 | | | Control 3 | 364.2 | 4.48 | 1.2 | 363.5 | 6.39 | 1.8 | | | Control 4 | 563.2 | 5.88 | 1.0 | 561.3 | 9.08 | 1.6 | Precision Performance: ISE-Serum Sodium (Na⁺, mmol/L) | Analyte | | Within Run | | | Total Precision | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Na+ | Sample | Mean | SD | %CV | Mean | SD | %CV | | | Control 1 | 146.6 | 0.70 | 0.5 | 145.9 | 1.04 | 0.7 | {7} 8 | | Control 2 | 135.7 | 0.66 | 0.5 | 136.1 | 0.92 | 0.7 | | --- | --- | --- | --- | --- | --- | --- | --- | | | Control 3 | 119.5 | 2.84 | 2.4 | 123.7 | 1.85 | 1.5 | | | Control 4 | 158.9 | 0.39 | 0.2 | 159.0 | 1.15 | 0.7 | Precision Performance: ISE-Serum Potassium (K⁺, mmol/L) | Analyte | | Within Run | | | Total Precision | | | | --- | --- | --- | --- | --- | --- | --- | --- | | K+ | Sample | Mean | SD | %CV | Mean | SD | %CV | | | Control 1 | 3.03 | 0.06 | 2.0 | 2.96 | 0.08 | 2.6 | | | Control 2 | 4.68 | 0.03 | 0.5 | 4.60 | 0.06 | 1.2 | | | Control 3 | 5.84 | 0.11 | 2.0 | 5.98 | 0.09 | 1.6 | | | Control 4 | 6.63 | 0.05 | 0.7 | 6.71 | 0.12 | 1.7 | Precision Performance: ISE-Serum Chloride (Cl⁻, mmol/L) | Analyte | | Within Run | | | Total Precision | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Cl⁻, | Sample | Mean | SD | %CV | Mean | SD | %CV | | | Control 1 | 100.3 | 0.61 | 0.6 | 100.3 | 0.66 | 0.7 | | | Control 2 | 94.7 | 058 | 0.6 | 94.2 | 0.65 | 0.7 | | | Control 3 | 84.7 | 2.07 | 2.4 | 86.1 | 0.95 | 1.1 | | | Control 4 | 118.0 | 0.35 | 0.3 | 118.2 | 1.37 | 1.2 | b. Linearity/assay reportable range: **Glucose:** A linearity range from 13 to 721 mg/dL (8 levels) was analyzed using commercially available linearity standards with five replicates of each level on the Carolina Liquid Chemistries CLC 6410. Results were analyzed by the Least Squares Statistical Method using EP evaluator (see table below). **Sodium:** A linearity range from 102-173 mmol/L (5 levels) was analyzed using commercially available linearity standards with five replicates of each level on the Carolina Liquid Chemistries CLC 6410. Results were analyzed by the Least Squares Statistical Method using EP evaluator (see table below). **Chloride:** A linearity range from 58 -167 mmol/L (5 levels) was analyzed using commercially available linearity standards with five replicates of each level on the Carolina Liquid Chemistries CLC 6410. Results were analyzed by the Least Squares Statistical Method using EP evaluator (see table below). **Potassium:** A linearity range from 1.8 -12.6 mmol/L (5 levels) was analyzed using commercially available linearity standards with five replicates of each level on the Carolina Liquid Chemistries CLC 6410. Results were analyzed by the Least Squares Statistical Method using EP evaluator (see table below). {8} Linearity Results: | Measurand | Slope | Intercept | R² | Sample Range Tested | Claimed Measuring Range | | --- | --- | --- | --- | --- | --- | | Glucose (mg/dL) | 1.010 | 1.26 | 1.000 | 13 to 721 | 13-700 | | Sodium (mmol/L) | 0.976 | 2.67 | 0.987 | 102-173 | 102-173 | | Chloride (mmol/L) | 0.997 | 0.15 | 1.000 | 58 -167 | 70-150 | | Potassium (mmol/L) | 0.990 | 0.043 | 0.994 | 1.8 -12.6 | 3-10 | c. Traceability, Stability, Expected values (controls, calibrators, or methods): # ISE Calibrators and Selectivity Check Traceability: Carolina Liquid Chemistries ISE calibrators and Selectivity Check are traceable to NIST SRM 956C. Stability: Real time stability studies were performed. The study protocol and acceptance criteria were found acceptable. Results of the study support the shelf life of 12 months at $2 - 8^{\circ}\mathrm{C}$ . Once opened, Calibrator 1 and 2 are stable for 12 days when stored on-board at $2^{\circ}\mathrm{C}$ to $8^{\circ}\mathrm{C}$ . The Selectivity Check is stable for 5 days when stored on-board at $2^{\circ}\mathrm{C}$ to $8^{\circ}\mathrm{C}$ . Value assignment for the ISE calibrators: Each calibrator is value assigned using the average of 10 measurements following internal protocols. Target values and ranges: | | Target Value | | | | --- | --- | --- | --- | | Item | Calibrator 1 | Calibrator 2 | Selectivity Check | | Na+ (mmol/L) | 120 | 160 | 138 ± 1 | | K+ (mmol/L) | 3 | 7 | 4.1 ± 0.1 | | Cl- (mmol/L) | 80 | 120 | 102 ± 1 | # Glucose Traceability: Carolina Liquid Chemistries Glucose assay is traceable to NIST 917b. The sponsor recommends the use of Carolina Liquid Chemistries CLC 720 serum calibrator (previously cleared under in k053153) for the calibration of the glucose assay. {9} # d. Detection limit: Refer to the linearity study data above in M. 2.b. for the linearity results used to support the measuring range of all analytes. In addition, the sponsor conducted a Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) for Glucose assay according to the CLSI EP-17A guideline. Results are summarized in the table below. | Measurand | LoB | LoD | LoQ | | --- | --- | --- | --- | | Glucose (Serum) (mg/dL) | 0.8 | 1.4 | 1.4 | The sponsor claims the following measuring ranges: | Measurand | Measuring range | | --- | --- | | Glucose (mg/dL) | 13-700 | | Sodium (mmol/L) | 102-173 | | Chloride (mmol/L) | 70-150 | | Potassium (mmol/L) | 3-10 | # e. Analytical specificity: Effects of common endogenous substances including bilirubin, hemoglobin and triglycerides were evaluated by spiking serum pools with increasing amounts of interferents at two analyte levels. In addition, chemical additives, including Ascorbic acid and lithium heparin was evaluated for potential interference. The effect of drugs were not tested and has been referenced in the product insert to the "Young, D.S., Effects of Drugs on Clinical Laboratory Tests, 3rd ed. AACC Press, Washington, D.C., 1990, p.3 168, p. 3-180." The sponsor defined significant interference as a bias of $>10\%$ between the spiked and unspiked sample. The tested results are summarized below: # Glucose No significant interference was observed with Triglycerides up to $425\mathrm{mg / dL}$ , Bilirubin levels at $25\mathrm{mg / dL}$ , Hemoglobin levels at $500\mathrm{mg / dL}$ and Ascorbic Acid levels at $30\mathrm{mg / L}$ for either the normal glucose level or abnormal glucose level. No significant interference was observed with Lithium Heparin levels or EDTA levels up to $80\mathrm{U / mL}$ for either the normal or abnormal glucose level. # Sodium No significant interference was observed with Triglycerides up to $537.8\mathrm{mg / dL}$ , Bilirubin levels at $25\mathrm{mg / dL}$ , Hemoglobin levels at $500\mathrm{mg / dL}$ , and Ascorbic Acid levels at $30\mathrm{mg / dL}$ for either the normal or abnormal sodium levels. No significant {10} interference was observed with Lithium Heparin levels up to 80 U/mL for either the normal or abnormal sodium level. ## Chloride No significant interference was observed with Triglycerides up to 537.8 mg/dL, Bilirubin levels at 25 mg/dL, Hemoglobin levels at 500 mg/dL, and Ascorbic Acid levels at 30 mg/dL for either the normal or abnormal chloride levels. No significant interference was observed with Lithium Heparin levels up to 80 U/mL for either the normal or abnormal chloride level. ## Potassium No significant interference was observed with Triglycerides up to 537.8 mg/dL, Bilirubin levels at 25 mg/dL, and Ascorbic Acid levels at 30 mg/dL for either the normal or abnormal potassium levels. No significant interference was observed with Lithium Heparin levels up to 80 U/mL for either the normal or abnormal potassium level. Because of the known interference of hemolysis on potassium, sponsor has the following limitation stated in the labeling: "Hemolyzed samples should not be used with this assay." In addition, sponsor also states that grossly lipemic samples should not be used with this assay. f. Assay cut-off: Not applicable. ## 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were conducted following CLSI EP9- A2. Separate comparison studies were performed for both serum and li-heparin plasma samples. Samples were analyzed on the Carolina Liquid Chemistries CLC 6410 versus the Olympus AU 400 Clinical Chemistry Analyzer. Some samples were altered (spiked or diluted) in order to span the entire claimed measuring range. The study result are summarized in the below table. | Test | Sample type | Total # samples | Sample Range tested | Claimed measuring range | Slope | Intercept | r | | --- | --- | --- | --- | --- | --- | --- | --- | | Glu mg/dL | Serum | 66 | 14-638 | 13-700 | 0.977 | 3.50 | 0.9989 | | | Plasma | 60 | 17-675 | 13-700 | 0.996 | -0.09 | 0.9998 | | Na+ | Serum | 60 | 109-171 | 102-173 | 0.992 | 1.04 | 0.9963 | {11} | mmol/L | Plasma | 60 | 106-170 | 102-173 | 0.988 | 1.88 | 0.9896 | | --- | --- | --- | --- | --- | --- | --- | --- | | K+ mmol/L | Serum | 60 | 3.0-9.5 | 3-10 | 1.008 | -0.025 | 0.9990 | | | Plasma | 60 | 3.0-9.9 | 3-10 | 0.987 | 0.032 | 0.9995 | | Cl- mmol/L | Serum | 66 | 73-140 | 70-150 | 0.941 | 5.69 | 0.9917 | | | Plasma | 60 | 73-147 | 70-150 | 0.988 | 0.83 | 0.9945 | b. Matrix Comparison: Matrix effect has been evaluated through separate method comparison studies using both serum and Li-heparin plasma samples. Please see item above in M. 2.a. The sponsor concluded that Lithium heparin plasma is acceptable to be used with the ISE and glucose assays. 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: The sponsor has provided the following Expected Values in the labeling: Glucose: Serum/Plasma 74-106 mg/dL Sodium: Serum/Plasma 136.0-145.0 mmol/L Chloride: Serum/Plasma 98.0-107 mmol/L Potassium: Serum 3.5-5.1 mmol/L; Plasma- (Male):3.5-4.5 mmol/L, (Female): 3.4-4.4 mmol/L References: Tietz NW, editor: Fundamentals of Clinical Chemistry, 6th ed., WB Saunders Co., PA, 2008. {12} N. Instrument Name: Carolina Liquid Chemistries CLC6410 Chemistry Analyzer O. System Descriptions: 1. Modes of Operation: Random access instrument with ISE Module. 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: Bar code identification 4. Specimen Sampling and Handling: Random access and stat mode operation. Samples are loaded on sample disk. 5. Calibration: Glucose An on-board calibration stability was performed on the Glucose Assay. The result supports 30 days without recalibration or adding new reagent. ISE Calibration should be performed every day and with each new lot of reagent. 6. Quality Control: The sponsor recommends on their labeling that “The validity of the reaction should be monitored by use of control samples with known normal and abnormal values. These controls should be run after each calibration and with every working shift in which assays are performed. It is recommended that each laboratory establish their own frequency of control. Each user should follow the state and local guidelines regarding the quality control procedures”. 13 {13} P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: A carry-over study has been performed and found to be acceptable. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10, and 21 CFR 801.109(b)(1). R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 14