EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT

{0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k080823 B. Purpose for Submission: New device C. Measurand: Amylase, Blood Urea Nitrogen (BUN), Glucose, Triglyceride, Uric Acid D. Type of Test: Amylase-enzymatic reaction Blood Urea Nitrogen (BUN)-kinetic reaction Glucose-enzymatic reaction Triglyceride-enzymatic reaction Uric acid E. Applicant: Medica Corporation F. Proprietary and Established Names: EasyRA Amylase Reagent EasyRA Blood Urea Nitrogen (BUN) Reagent EasyRA Glucose-Hexokinase Reagent EasyRA Triglyceride Reagent EasyRA Uric Acid Reagent G. Regulatory Information: | Device Classification Name | Device Classification | Regulation Number | Product Code | Panel | | --- | --- | --- | --- | --- | | Amylase | Class II | 21 CFR 862.1070 | JFJ | Chemistry (75) | | Urea Nitrogen | Class II | 21 CFR 862.1770 | CDQ | Chemistry (75) | | Hexokinase, glucose | Class II | 21 CFR 862.1345 | CFR | Chemistry (75) | | Triglyceride | Class I * | 21 CFR 862.1705 | CDT | Chemistry (75) | | Uric acid | Class I, reserved | 21 CFR 862.1775 | KNK | Chemistry (75) | *Meets limitations to exemption in 21 CFR 862.9(c)(4) {1} H. Intended Use: 1. Intended use(s): EasyRA Amylase Reagent The EasyRA amylase Reagent (AMY) is for the measurement of a-Amylase in serum using the “EasyRA chemistry analyzer”. Amylase measurements are used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For *in vitro* diagnostic use only. EasyRA Blood Urea Nitrogen (BUN) Reagent The EasyRA Blood Urea Nitrogen (BUN) Reagent is for the measurement of urea in serum using the “EasyRA chemistry analyzer”. Urea measurements in serum are used for the diagnosis and treatment of certain renal and metabolic diseases. For *in vitro* diagnostic use only. EasyRA Glucose-Hexokinase Reagent The EasyRA Glucose hexokinase (GLU-H) Reagent is for the measurement of glucose in serum using the “EasyRA chemistry analyzer”. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For *in vitro* diagnostic use only. EasyRA Triglyceride Reagent The EasyRA Triglyceride (TRIG) Reagent is for the measurement of triglycerides in serum using the “EasyRA chemistry analyzer”. Triglyceride measurements are used in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. For *in vitro* diagnostic use only. EasyRA Uric Acid Reagent The EasyRA Uric Acid (URIC) Reagent is for the measurement of uric acid in serum using the “EasyRA chemistry analyzer”. Uric Acid measurements are used in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. For *in vitro* diagnostic use only. 2. Indication(s) for use: See intended use(s) above. 3. Special conditions for use statement(s): For prescription use. 2 {2} 4. Special instrument requirements: Medica EasyRA chemistry analyzer I. Device Description: The EasyRA Amylase test is provided in 4 ready-to-use plastic wedges, each containing 39 mL of reagent. The reagent consists of a MES buffer with 2-chloro-4-nitrophenol-α-D-maltotrioside (CNPG3), sodium chloride, sodium acetate, calcium acetate, potassium thiocyanate, and sodium azide. The EasyRA BUN test is provided in 4 ready-to-use plastic wedges, each containing 39 mL of reagent. The reagent consists of buffer with alpha-ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate, NADH analog, stabilizers and preservatives. The EasyRA Glucose test is provided in 4 ready-to-use plastic wedges, each containing 39 mL of reagent. The reagent consists of buffer, nicotinamide adenine dinucleotide (NAD), adenosine triphosphate (ATP), magnesium, hexokinase, glucose-6-phosphate dehydrogenase, stabilizers, and preservatives. The EasyRA Triglycerides test is provided in 4 ready-to-use plastic wedges, each containing 37 mL of reagent. The reagent consists of buffer, magnesium (Mg++), p-chlorophenol, ATP, 4-aminoantipyrine, lipoprotein lipase, glycerol kinase, G-3-P oxidase, horseradish peroxidase, stabilizers and preservatives. The EasyRA Uric Acid test is provided in 4 ready-to-use plastic wedges, each containing 37 mL of reagent. The reagent consists of 3,5-dichloro-2-hydroxybenzene sulfonate (DHBS), 4-aminoantipyrine, horseradish peroxidase, uricase, stabilizers and preservatives. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Diagnostics α-Amylase Reagent Roche Diagnostics BUN Reagent Roche Diagnostics Glucose Reagent Roche Diagnostics Triglycerides Reagent Roche Diagnostics Uric Acid Reagent 2. Predicate K number(s): k933397, k011843, k002694, k961282, k961281, k961586 {3} 3. Comparison with predicate: | Amylase Similarities and Differences | | | | --- | --- | --- | | Item | Medica Amylase Reagent | Roche α-Amylase Reagent | | Intended Use | Clinical chemistry reagent used to provide a quantitative measurement of amylase in human serum, using the EasyRA chemistry analyzer. | Clinical chemistry reagent used to provide a quantitative measurement of amylase in human serum, using an automated chemical analyzer | | Test Methodology | An enzymatic reaction based on the catalytic activity of a serum based enzyme, which is quantified by monitoring the reaction rate. The chromogen absorbs light of specific wavelength, where the EasyRA measures absorbance according to Beer's law. | An enzymatic reaction based on the catalytic activity of a serum based enzyme, which is quantified by monitoring the reaction rate. The chromogen absorbs light of specific wavelength, where the COBAS-Mira measures absorbance according to Beer's law. | | Sample type | Serum | Serum | | Reagent type | Liquid ready-for-use | Liquid ready-for-use | | Linearity range | 2 – 1200 U/L | Up to 2000 U/L | | Wavelength | 405 nm | 405 nm | | Reaction type | Enzyme | Enzyme | | BUN Similarities and Differences | | | | --- | --- | --- | | Item | Medica EasyRA BUN | Roche BUN Reagent | | Intended Use | Clinical chemistry reagent used to provide a quantitative measurement of urea in human serum, using the EasyRA chemistry analyzer. | Clinical chemistry reagent used to provide a quantitative measurement of urea in human serum, using an automated chemical analyzer | | Test Methodology | An enzymatic reaction of Urea to L-glutamate with the concurrent reduction of NADH to NAD. The rate of change in absorption of the NADH chromogen is monitored with time on the EasyRA to establish the amount of urea | An enzymatic reaction of Urea to L-glutamate with the concurrent reduction of NADH to NAD. The rate of change in absorption of the NADH chromogen is monitored with time on the Cobas- | {4} | Gucose Similarities and Differences | | | | --- | --- | --- | | Item | Medica EasyRA Bln | Roche Bln Reagent | | | present. | Mira to establish the amount of urea present. | | Sample type | Serum | Serum | | Reagent type | Liquid ready-for-use | Liquid ready-for-use | | Linearity range | 1.0 – 70.0 mg/dL | Up to 80 mg/dL | | Wavelength | 340 nm | 340 nm | | Reaction type | Kinetic | Kinetic | | Reagent storage | 2 – 8 °C | 2 – 8 °C | | Glucose Similarities and Differences | | | | --- | --- | --- | | Item | Medica EasyRA Glu | Roche Glucose Reagent | | Intended Use | Clinical chemistry reagent used to provide a quantitative measurement of Glucose in human serum, using the EasyRA chemistry analyzer. | Clinical chemistry reagent used to provide a quantitative measurement of Glucose in human serum, using an automated chemical analyzer | | Test Methodology | An enzymatic reaction based on the complete oxidation of glucose in serum and the simultaneous reduction on NAD to NADH (chromogen). The chromogen absorbs light of specific wavelength, where the EasyRA measures absorbance according to Beer's law. | An enzymatic reaction based on the complete oxidation of glucose in serum and the simultaneous reduction on NAD to NADH (chromogen). The chromogen absorbs light of specific wavelength, where the COBAS-Mira measures absorbance according to Beer's law. | | Sample type | Serum | Serum | | Reagent type | Liquid ready-for-use | Liquid ready-for-use | | Linearity range | 2 – 600 mg/dL | Up to 800 mg/dL | | Wavelength | 340 nm | 340 nm | | Reaction type | End point | End point | | Reagent storage | 2 – 8 °C | 2 – 8 °C | {5} | Triglycerides Similarities and Differences | | | | --- | --- | --- | | Item | Medica EasyRA Trig | Roche Triglycerides | | Intended Use | Clinical chemistry reagent used to provide a quantitative measurement of triglycerides in human serum, using the EasyRA chemistry analyzer. | Clinical chemistry reagent used to provide a quantitative measurement of triglycerides in human serum, using an automated chemical analyzer | | Test Methodology | An enzymatic reaction based on the catalytic activity of a serum based enzyme, which is quantified by monitoring the reaction rate. The chromogen absorbs light of specific wavelength, where the EasyRA measures absorbance according to Beer's law. | An enzymatic reaction based on the catalytic activity of a serum based enzyme, which is quantified by monitoring the reaction rate. The chromogen absorbs light of specific wavelength, where the COBAS-Mira measures absorbance according to Beer's law. | | Sample type | Serum | Serum | | Reagent type | Liquid ready-for-use | Liquid ready-for-use | | Linearity range | 3 – 750 mg/dL | Up to 900 mg/dL | | Wavelength | 520/700 nm | 550 nm | | Reaction type | End point | End point | | Reagent storage | 2 – 8 °C | 2 – 8 °C | | Uric Acid Similarities and Differences | | | | --- | --- | --- | | Item | Medica Easy RA Uric Acid | Roche Uric Acid | | Intended Use | Clinical chemistry reagent used to provide a quantitative measurement of uric acid in human serum, using the EasyRA chemistry analyzer. | Clinical chemistry reagent used to provide a quantitative measurement of uric acid in human serum, using an automated chemical analyzer | | Test Methodology | An enzymatic reaction based on the oxidation of Uric Acid to produce hydrogen peroxide in the presence of uricase. The H2O2is further reduced to produce a chromogen. The chromogen absorption is | An enzymatic reaction based on the oxidation of Uric Acid to produce hydrogen peroxide in the presence of uricase. The H2O2is further reduced to produce a chromogen. The chromogen absorption is | {6} | Uric Acid Similarities and Differences | | | | --- | --- | --- | | Item | Medica Easy RA Uric Acid | Roche Uric Acid | | | measured by the EasyRA and is directly related to the Uric Acid concentration using Beer’s Law. | reduced to produce a chromogen. The chromogen absorption is measured by the Cobas-Mira and is directly related to the Uric Acid using Beer’s Law. | | Reagent type | Liquid ready-for-use | Liquid ready-for-use | | Linearity range | 0.11 – 12 mg/dL | Up to 20 mg/dL | | Wavelength | 520/600 nm | 550 nm | | Reaction type | End point | End point | | Reagent storage | 2 – 8 °C | 2 – 8 °C | ## K. Standard/Guidance Document Referenced (if applicable): Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (CLSI EP6-A) Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition (CLSI EP9-A2) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline- Second Edition (CLSI EP5-A2) ## L. Test Principle: The Medica EasyRA Amylase test involves the use of a chromogenic substrate, 2-chloro-4-nitrophenol-α-D-maltotrioside (CNPG3). The rate of hydrolysis of CNPG3 by α-amylase to release 2-Chloro-4-nitrophenol can be detected spectrophotometrically to give a direct measurement of α-amylase activity in the sample. For the Medica EasyRA BUN test, urea in the sample is first hydrolyzed by urease to give ammonia and carbon dioxide. The ammonia produced reacts with 2-oxoglutarate and stabilized NADH analog in the presence of glutamate dehydrogenase (GLDH) to form glutamate and NAD (II). The decrease in the concentration of the reduced cofactor (NADH), monitored at 340 nm is proportional to the concentration of the Urea in the sample. For the Medica EasyRA GLU-H test, glucose is phosphorylated to form glucose-6-phosphate (G-6-P). G-6-P is then oxidized by glucose-6-phosphate dehydrogenase in the presence of NAD producing 6-phosphogluconate and NADH. The formation of {7} NADH causes an increase in absorbance at 340 nm, which is proportional to the concentration of the glucose in the sample. For the Medica EasyRA TRIG test, serum triglycerides are hydrolyzed to glycerol and free fatty acids by lipase. In the presence of ATP and glycerol kinase (GK), the glycerol is phosphorylated to glycerol-1-phosphate, which is then oxidized by glycerol phosphate oxidase (GPO) to produce hydrogen peroxide. The hydrogen peroxide causes oxidative coupling of p-chlorophenol and 4 amino-antipyrine, which produces a red colored quinoneimine dye complex. The absorbance of the dye at 520 nm is proportional to the concentration of triglyceride in the sample. For the Medica EasyRA Uric acid test, hydrogen peroxide is formed by the action of uricase on uric acid. The hydrogen peroxide is then reacted with 3,5-dichloro-2-hydroxybenzene sulfonate (DHBS) and 4-aminoantipyrine forming a red colored quinoneimine dye, with maximum absorbance at 520 nm. ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: #### a. Precision/Reproducibility: Within Run and Total precision were determined following CLSI EP-A2. Three levels of commercial serum-based Quality Control material were tested on one EasyRA analyzer twice a day over a twenty-day period. The data is summarized below. Additionally, to verify precision in the extended measuring range of each test (see section 1.b. below), one sample was diluted 1:2 with saline on board the analyzer and assayed twenty times (n=20) in one assay run. Amylase | | Level 1 | Level 2 | Level 3 | Diluted | | --- | --- | --- | --- | --- | | Mean (U/L) | 45 | 85 | 296 | 1781 | | Within Run Precision: | | | | | | Std. Dev. | 0.8 | 0.7 | 1.9 | | | CV % | 1.8 | 0.8 | 0.6 | 0.9 | | Total Precision: | | | | | | Std. Dev. | 0.9 | 0.9 | 2.9 | | | CV% | 1.9 | 1.1 | 1.0 | | {8} BUN | | Level 1 | Level 2 | Level 3 | Diluted | | --- | --- | --- | --- | --- | | Mean (mg/dL) | 15.2 | 21.3 | 55.0 | 96.2 | | Within Run Precision: | | | | | | Std. Dev. | 0.19 | 0.33 | 0.41 | | | CV% | 1.28 | 1.55 | 0.74 | 1.4 | | Total Precision: | | | | | | Std. Dev. | 0.29 | 0.39 | 0.68 | | | CV% | 1.93 | 1.90 | 1.24 | | Glucose Hexokinase | | Level 1 | Level 2 | Level 3 | Diluted | | --- | --- | --- | --- | --- | | Mean (mg/dL) | 61 | 111 | 270 | 805 | | Within Run Precision: | | | | | | Std. Dev. | 0.7 | 0.7 | 1.1 | | | CV% | 1.1 | 0.6 | 0.4 | 1.98 | | Total Precision: | | | | | | Std. Dev. | 0.9 | 1.5 | 2.6 | | | CV% | 1.5 | 1.4 | 1.0 | | Triglycerides | | Level 1 | Level 2 | Level 3 | Diluted | | --- | --- | --- | --- | --- | | Mean (mg/dL) | 78 | 90 | 252 | 1324 | | Within Run Precision: | | | | | | Std. Dev. | 0.7 | 0.6 | 1.3 | | | CV% | 0.9 | 0.6 | 0.5 | 1.98 | | Total Precision: | | | | | | Std. Dev. | 1.6 | 1.0 | 2.8 | | | CV% | 2.0 | 1.2 | 1.1 | | Uric Acid | | Level 1 | Level 2 | Level 3 | Diluted | | --- | --- | --- | --- | --- | | Mean (mg/dL) | 4.37 | 4.16 | 9.70 | 31.9 | | Within Run Precision: | | | | | | Std. Dev. | 0.04 | 0.05 | 0.07 | | | CV% | 0.94 | 1.30 | 0.70 | 0.51 | | Total Precision: | | | | | | Std. Dev. | 0.19 | 0.18 | 0.23 | | | CV% | 4.36 | 4.36 | 2.35 | | 9 {9} b. Linearity/assay reportable range: Linearity studies were performed following the CLSI protocol EP6-A. Commercially available linearity standards were used unless noted otherwise. Amylase For the Amylase assay, the concentrations of samples tested ranged from 1 to 1360 U/L. The data was analyzed using linear regression as well as second and third order non-linear fitted polynomial regression. The third order model fit the data better than the linear and second order models. However, for all dilution points the relative differences between the linear and third order models were within ±15% or below the medical decision point of 100 U/L ±15 U/L. The results are summarized below. Fitted regression models are: Linear: y = 1.0007x + 1.2297, Std. Error=16.487 Second order: y = 2E-05x² + 0.9733x + 4.0426, Std. Error 16.559 Third order: y = 1E-07x³ - 0.0002x² + 1.0785x - 0.1589, Std. Error=15.434 The results of this study support the sponsor's claim that the device is linear from 2 U/L to 1200 U/L. The extended measuring range (1201 to 2400 U/L) was evaluated with four standards with target values ranging from 1100 to 2400 U/L. Recovery with the Easy RA on-board dilution was compared to manual dilutions. Recoveries ranged from 99% to 103%. BUN For the BUN assay, the concentrations of samples tested ranged from 0.9 to 73.7 mg/dL. A BUN stock solution was prepared gravimetrically from commercially available material. Dilutions of varying BUN concentration were then prepared using saline and tested. The data was analyzed using linear regression as well as second and third order non-linear fitted polynomial regression. The third order model fit the data better than the linear and second order models. However, for all dilution points the relative differences between the first and third order models were within ±4.5% or ±1.22 mg/dL at or below the medical decision point of 27 mg/dL. The results are summarized below. Fitted regression models are: Linear: y = 0.9593 x + 0.5657, Std. Error=0.715 Second order: y = -0.0011x² + 1.0329 x + 0.0669, Std. Error=0.494 Third order: y = -1E-05x³ - 0.0004x² + 0.9923x - 0.2103, Std. Error=0.493 {10} The results of this study support the sponsor’s claim that the device is linear from 1 mg/dL to 70 mg/dL. The extended measuring range (71 to 140 mg/dL) was evaluated with four standards with values ranging from 90 to 130 mg/dL. Recovery with the Easy RA on-board dilution was compared to manual dilutions. Recoveries ranged from 99% to 102%. ## Glucose-hexokinase For the Glucose assay, the concentrations of samples tested ranged from 2 to 716 mg/dL. The data was analyzed using linear regression as well as second and third order non-linear fitted polynomial regression; however, the first order regression had the best fit. The analysis yielded the following equation: Linear: $y = 0.9898x + 1.39$, Std. Error=3.451 The results of this study support the sponsor’s claim that the device is linear from 2 mg/dL to 600 mg/dL. The extended measuring range (601 to 1200 mg/dL) was evaluated with three standards with values ranging from 675 to 1062 mg/dL. Recovery with the Easy RA on-board dilution was compared to manual dilutions. Recoveries ranged from 98% to 99%. ## Triglycerides For the Triglycerides assay, the concentrations of samples tested ranged from 2 to 852 mg/dL. The data was analyzed using linear regression as well as second and third order non-linear fitted polynomial regression. The third order model fit the data better than the linear and second order models. However, for all dilution points the relative differences between the first and third order models were within ±12.5% or ±20 mg/dL below the medical decision point of 160 mg/dL. The results are summarized below. Fitted regression models are: Linear: $y = 0.9794x + 2.085$, Std. Error=4.094 Second order: $y = -7E - 05x^2 + 1.03x - 1.6287$, Std. Error=1.825 Third order: $y = -6E - 08x^3 - 8E - 06x^2 + 1.007x - 0.9432$ Std. Error= 1.651 The results of this study support the sponsor’s claim that the device is linear from 3 mg/dL to 750 mg/dL. The extended measuring range (751 to 1400 mg/dL) was evaluated with three standards with values ranging from 798 to 1228 mg/dL. Recovery with the Easy RA on-board dilution was compared to manual dilutions. Recoveries ranged from 101-102%. 11 {11} 12 # Uric Acid For the uric acid assay, the concentrations of samples tested ranged from 0.11 to 23.46 mg/dL. The data was analyzed using linear regression as well as second and third order non-linear fitted polynomial regression. The third order model fit the data better than the linear and second order models. However, for all dilution points the relative differences between the first and third order models were within ±8.5% or ±0.51 mg/dL, whichever is greater. The results are summarized below. Fitted regression models are: Linear: y = 1.0336 x - 0.173, Std. Error=0.279 Second order: y = 0.005x² + 0.9246 x + 0.0315, Std. Error=0.093 Third order: y = -0.0002x³ + 0.0017x² + 0.867x + 0.0827, Std. Error=0.076 The results of this study support a claimed assay range of 0.11 to 12 mg/dL. The extended measuring range (12 to 24 mg/dL) was evaluated with two standards with values 19.6 and 25 mg/dL. Recovery with the Easy RA on-board dilution was compared to manual dilutions. Recoveries were 98% for each standard tested. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Calibrators and controls were reviewed under a separate 510(k) and are sold separately. d. Detection limit: To determine the limit of blank (LoB) for each EasyRA test (Amylase, BUN, Glucose, Triglyceride, Uric Acid) deionized water was assayed twenty (20) times on each of three Easy RA analyzers for a total of sixty (60) replicates. The data were analyzed following the recommendations in CLSI EP 17. To determine the limit of detection (LoD) for each test a serum sample with low analyte concentration was prepared and analyzed 20 times on each of three EasyRA analyzers. The results for LoB and LoD are summarized in the following table: | Device | LoB | LoD | | --- | --- | --- | | Amylase | 0.78 U/L | 1.04 U/L | | BUN | 0.68 mg/dL | 1.0 mg/dL | | Glucose | 0.56 mg/dL | 1.0 mg/dL | | Triglycerides | 1.35 mg/dL | 2.16 mg/dL | | Uric Acid | 0.065 mg/dL | 0.11 mg/dL | {12} e. Analytical specificity: Evaluation of interfering substances was based on CLSI EP-7A and performed at two concentrations of analyte. Samples with increasing amounts of hemoglobin, bilirubin or triglycerides (Intralipid®) were tested and compared to the same sample without added interferent, unless otherwise noted. Studies to evaluate potential lipid interference in the Glu-H test were performed using LipoClear lipid clearing reagent. The sponsor defined interference as the highest level tested that does not cause >10% change in analytical result. The results are summarized in the table below. | | Analyte level tested | No interference up to | | --- | --- | --- | | Amylase | | | | Hemoglobin | 68 U/L, 92 U/L | 125 mg/dL | | | | | | Triglyceride | 57 U/L, 97 U/L | 1374 mg/dL | | | | | | Bilirubin | 86 U/L, 93 U/L | 25 mg/dL | | | | | | BUN | | | | Hemoglobin | 16.2 mg/dL, 28 mg/dL | 300 mg/dL | | | | | | Triglyceride | 18.1 mg/dL, 31.6 mg/dL | 811 mg/dL | | | | | | Bilirubin | 19.6 mg/dL, 30 mg/dL | 20 mg/dL | | | | | | Glu-H | | | | Hemoglobin | 42 mg/dL, 94 mg/dL | 31 mg/dL | | | | | | Triglyceride | 150 mg/dL, 250 mg/dL | 450mg/dL | | | | | | Bilirubin | 45 mg/dL, 82 mg/dL | 10 mg/dL | | | | | {13} | Triglycerides | | | | --- | --- | --- | | Hemoglobin | 136 mg/dL, 149 mg/dL | 500 mg/dL | | | | | | Bilirubin | 122 mg/dL, 298 mg/dL | 5.5 mg/dL | | Uric Acid | | | | Hemoglobin | 3.35 mg/dL, 5.53 mg/dL | 52 mg/dL | | | | | | Triglyceride | 3.84 mg/dL, 5.8 mg/dL | 400 mg/dL | | | | | | Bilirubin | 2.24 mg/dL, 4.82 mg/dL | 25 mg/dL | The labeling for all tests contains precautionary language that hemolyzed samples should not be used. For glucose and triglycerides, there is an additional warning that icteric samples should not be used. The sponsor did not perform any studies to investigate the effect of exogenous substances however a literature reference is included to alert users that potential interferences from substances such as common over-the-counter and prescription pharmaceuticals should be checked. The sponsor cites the following references for exogenous interference in the labeling. Young DS. Effects of Drugs on Clinical Laboratory Tests 4th ed. Washington, DC: AACC Press; 1995. Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests. 2nd ed. Washington, DC. AACC Press; 1997. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Studies were performed using CLSI EP9-A2 as a guide. Amylase {14} A total of 99 serum samples were tested with the Medica EasyRA amylase test system and with the Roche Amylase reagent on the COBAS MIRA test system. Of these sera, seven (7) were either spiked with amylase to create samples with high amylase concentration or diluted to create low level samples. Samples ranged in value from 2 to $1150\mathrm{U/L}$ amylase and were tested in singlicate on the Medica test system and in duplicate on the Roche test system. The comparison resulted in a slope of 1.025, an intercept of 6.11, and a correlation coefficient of $\mathbb{R}^2 = 0.996$. ## BUN A total of 60 serum samples were tested with the Medica EasyRA BUN test system and with the Roche BUN reagent on the COBAS MIRA test system. Of these sera, three (3) were spiked with BUN to create samples with high BUN concentration. Samples ranged in value from 5.4 to $65.5\mathrm{mg/dL}$ BUN and were tested in singlicate on the Medica test system and in duplicate on the Roche test system. The comparison resulted in a slope of 1.04, an intercept of 1.04, and a correlation coefficient of $\mathbb{R}^2 = 0.995$. ## Glucose A total of 60 serum samples were tested with the Medica EasyRA Glu-H test system and with the Roche Glu-H reagent on the COBAS MIRA test system. Of these sera three (3) were either spiked with glucose to create samples with high glucose concentration or diluted. Samples ranged in value from 3 to $579\mathrm{mg/dL}$ and were tested in singlicate on the Medica test system and in duplicate on the Roche test system. The comparison resulted in a slope of 0.999, an intercept of -4.02, and a correlation coefficient of $\mathbb{R}^2 = 0.997$. ## Triglycerides A total of 60 serum samples were tested with the Medica EasyRA Triglycerides test system and with the Roche Triglycerides reagent on the COBAS MIRA test system. Of these sera three (3) were spiked to create samples with high triglycerides concentration. Samples ranged in value from 3 to $726\mathrm{mg/dL}$ and were tested in singlicate on the Medica test system and in duplicate on the Roche test system. The comparison resulted in a slope of 0.994, an intercept of 8.01, and a correlation coefficient of $\mathbb{R}^2 = 0.998$. ## Uric Acid A total of 48 serum samples were tested with the Medica EasyRA Uric Acid test system and with the Roche Uric Acid reagent on the COBAS MIRA test system. Of these sera five (5) were spiked to create samples with high uric acid concentration. Samples ranged in value from 1.49 to $12\mathrm{mg/dL}$ and were tested in singlicate on the Medica test system and in duplicate on the Roche test system. The comparison resulted in a slope of 1.04, an intercept of -0.19, and a correlation coefficient of $\mathbb{R}^2 = 0.991$. 15 {15} 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): 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The following reference is listed in the package insert: Tietz NW. Textbook of Clinical Chemistry, 3rd ed. WB Saunders and Co., Philadelphia, PA, p. 831-832 (1994). Reference ranges for analytes in this review are as follows: | | Normal Range | | --- | --- | | Amylase | 25-94 U/L | | BUN | 11-37 mg/dL | | Glucose | 70-105 mg/dL | | Triglycerides | 40-160 mg/dL (Men) | | | 35-135 mg/dL (Women) | | Uric Acid | 3.5-7.2 mg/dL (Men) | | | 2.6-6.0 mg/dL (Women) | The labeling contains recommendations that each laboratory should establish their own range of expected values. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. {16} O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 17