SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k053401 B. Purpose for Submission: New device C. Measurand: Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine, Alkaline Phosphatase, Total Bilirubin, Total Protein, AST (GOT), and ALT (GPT) D. Type of Test: Quantitative, Colorimetric Methodology E. Applicant: Arkray, Inc. F. Proprietary and Established Names: Arkray SpotChem II Chemistry Basic 1 Arkray SpotChem II Chemistry Basic 2 G. Regulatory Information: 1. Regulation section: | Chemistry Basic 1 | Calcium | Blood Urea Nitrogen | Glucose | Albumin | Creatinine | | --- | --- | --- | --- | --- | --- | | Device name | SpotChem II Chemistry Basic I test calcium | SpotChem II Chemistry Basic I test Blood Urea Nitrogen | SpotChem II Chemistry Basic I test Glucose | SpotChem II Chemistry Basic I test Albumin | SpotChem II Chemistry Basic I test Creatinine | | Trade name | SpotChem II Chemistry Basic 1 test Calcium | SpotChem II Chemistry Basic 1 test Blood Urea Nitrogen | SpotChem II Chemistry Basic 1 test Glucose | SpotChem II Chemistry Basic 1 test Albumin | SpotChem II Chemistry Basic 1 test Creatinine | | | | | | | | {1} | Chemistry Basic 1 | Calcium | Blood Urea Nitrogen | Glucose | Albumin | Creatinine | | --- | --- | --- | --- | --- | --- | | Common name | Calcium | Urea Nitrogen | Glucose | Albumin | Creatinine | | Classification name | Calcium test system | Urea Nitrogen Test System | Glucose Test System | Albumin Test System | Creatinine Test System | | Regulation Number | 21 CFR 862.1145 | 21 CFR 862.1770 | 21 CFR 862.1345 | 21 CFR 862.1035 | 21 CFR 862.1225 | | Panel | Chemistry | Chemistry | Chemistry | Chemistry | Chemistry | | Device Classification | II | II | II | II | II | | Product Code | CIC | JGZ | CGA | CIX | CGX | | Chemistry Basic 2 | ALP | Total Bilirubin | Total Protein | AST | ALT | | --- | --- | --- | --- | --- | --- | | Device name | SpotChem II Chemistry Basic I test ALP | SpotChem II Chemistry Basic I test Total Bilirubin | SpotChem II Chemistry Basic I test Total Protein | SpotChem II Chemistry Basic I test AST | SpotChem II Chemistry Basic I test ALT | | Trade name | SpotChem II Chemistry Basic I test ALP | SpotChem II Chemistry Basic I test Total Bilirubin | SpotChem II Chemistry Basic I test Total Protein | SpotChem II Chemistry Basic I test AST | SpotChem II Chemistry Basic I test ALT | | Common name | ALP | Total Bilirubin | Total Protein | AST | ALT | | Classification name | Alkaline Phosphatase or isoenzyme test system | Bilirubin (total or direct) test system | Total Protein test system | Aspartate amino transferase (AST/SGOT) test system | Alanine amino transferase (ALT/SGPT) test system | | Regulation Number | 21 CFR 862.1050 | 21 CFR 862.1110 | 21 CFR 862.1635 | 21 CFR 862.1100 | 21 CFR 862.1030 | | Panel | Chemistry | Chemistry | Chemistry | Chemistry | Chemistry | | Device Classification | II | II | II | II | II | | Product Code | CJE | CIG | CEK | CIS | CKA | # H. Intended Use: # 1. Intended use(s): Arkray SPOTCHEM II Chemistry Basic I is intended for the in vitro quantitative determination of calcium, BUN, glucose, albumin, creatinine concentration in {2} human serum, or human plasma from whole blood samples. This product is intended for use with the SPOTCHEM EZ analyzer (SP-4430). Arkray SPOTCHEM II Chemistry Basic II is intended for the in vitro quantitative determination of ALP, AST, and ALT activity and total bilirubin, and total protein concentration in human serum or human plasma from whole blood samples. This product is intended for use with the SPOTCHEM EZ analyzer (SP-4430). 2. Indication(s) for use: The SPOTCHEM II Chemistry Basic 1 Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The SPOTCHEM II Chemistry Basic 1 Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. The SPOTCHEM II Chemistry Basic 1 Glucose test is intended to measure the glucose concentration in serum, plasma and whole blood. 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. The SPOTCHEM II Chemistry Basic 1 Albumin test is intended to measure the albumin concentration in serum, plasma and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys. The SPOTCHEM II Chemistry Basic 1 Creatinine test is intended to measure the concentration of creatinine in serum, plasma and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The SPOTCHEM II Chemistry Basic 2 ALP test is intended to measure ALP activity in serum, plasma and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. 3 {3} The SPOTCHEM II Chemistry Basic 2 Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block. The SPOTCHEM II Chemistry Basic 2 Total Protein test is intended to measure total protein in serum, plasma and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders. The SPOTCHEM II Chemistry Basic 2 AST test is intended to measure AST activity in serum, plasma and whole blood. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. The SPOTCHEM II Chemistry Basic 2 ALT test is intended to measure ALT activity in serum, plasma and whole blood. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. 3. Special conditions for use statement(s): For Prescription use only. 4. Special instrument requirements: Arkray SPOTCHEM EZ Analyzer (SP-4430) (Previously cleared under k040332) I. Device Description: The SPOTCHEM II Chemistry Basic 1 and Chemistry Basic 2 tests are in vitro diagnostic procedures intended to measure calcium, blood urea nitrogen, glucose, albumin and creatinine; and total bilirubin, total protein, ALP, AST, and ALT quantitatively in human serum and plasma (whole blood) on the SPOTCHEM EZ Analyzer (SP-4430). Note: Although the whole blood is placed on the instrument, the measurement is from plasma because there is a centrifuge on the SPOTCHEM EZ (SP-4430) that separates the whole blood, and the plasma is then analyzed. The SPOTCHEM II Chemistry Basic 1 and Chemistry Basic 2 Reagent Strips are composed of a plastic strip to which five multi-layered test fields were affixed. The layers consist of a sample-retention layer, a layer containing the reagents and a support layer. 4 {4}   A fixed amount of serum or plasma is placed on the test field of the reagent strip and spreads in a uniform fashion across the entire surface of the sample retention layer. The serum or plasma then permeates into the reagent layer where the reaction is initiated. ## J. Substantial Equivalence Information: 1. Predicate device name(s): - SPOTCHEM II ALT: k040332 - SPOTCHEM EZ (SP-4430) Chemistry Analyzer: k040332 - SPOTCHEM II Glucose, AST: k041427 - SPOTCHEM II Calcium, BUN: k050077 - SPOTCHEM II Creatinine, ALP: k050652 - SPOTCHEM II Total Bilirubin, Total Protein, Albumin: k051432 2. Predicate 510(k) number(s): See Predicate device name(s) above. 3. Comparison with predicate: | Chemistry Basic 1 | Calcium | BUN | Glucose | Albumin | Creatinine | | --- | --- | --- | --- | --- | --- | | Predicate Methodology | colorimetric k50077 | Colorimetric k050077 | Colorimetric k041427 | Colorimetric k051432 | Colorimetric k050652 | | Test Methodology | colorimetric | colorimetric | colorimetric | Colorimetric | colorimetric | | Predicate Reagent Storage | 2-8°C | 2-8°C | 2-8°C | 2-8°C | 2-8°C | | Test Reagent Storage | 2-8°C | 2-8°C | 2-8°C | 2-8°C | 2-8°C | | Predicate Sample types | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | | Test Sample Types | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | | Correlation with Predicate device | N = 40. Samples spanned from 5.1 to 15.2 | N = 40. Samples spanned from 7 mg/dL to 92 | N = 40. Samples spanned from 30 mg/dL to | N = 40. Samples spanned from 1.9 g/dL to 5.8 | N = 40. Samples spanned from 0.7 mg/dL to | {5} | Chemistry Basic 1 | Calcium | BUN | Glucose | Albumin | Creatinine | | --- | --- | --- | --- | --- | --- | | | mg/dL. The regression equation was y = 0.97x + 0.14 and r = 0.993. | mg/dL. The regression equation was y = 1.08x - 0.43 and r = 0.997. | 406 mg/dL. The regression equation was y = 1.07x - 7.19 and r = 0.997. | g/dL. The regression equation was y = 0.99x + 0.07 and r = 0.976. | 15.3 mg/dL. The regression equation was y = 1.07x - 0.00 and r = 0.997. | | Chemistry Basic 2 | Total Bilirubin | Total Protein | ALP | AST | ALT | | Predicate Methodology | colorimetric k051432 | colorimetric k051432 | colorimetric k050652 | Colorimetric k041427 | colorimetric k040332 | | Test Methodology | colorimetric | colorimetric | colorimetric | Colorimetric | colorimetric | | Predicate Reagent Storage | 2-8°C | 2-8°C | 2-8°C | 2-8°C | 2-8°C | | Test Reagent Storage | 2-8°C | 2-8°C | 2-8°C | 2-8°C | 2-8°C | | Predicate Sample types | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | | Test Sample Types | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | | Correlation with Predicate device | N = 40. Samples spanned from 0.3 mg/dL to 8.7 mg/dL. The regression equation was y = 1.00x - 0.09 and r = 0.999. | N = 40. Samples spanned from 3.3 g/dL to 10.4 g/dL. The regression equation was y = 0.98x - 0.03 and r = 0.986. | N = 40. Samples spanned from 62 IU/L to 685 IU/L. The regression equation was y = 1.04x - 9.34 and r = 0.998. | N = 40. Samples spanned from 11 IU/L to 267 IU/L. The regression equation was y = 0.95x + 2.62 and r = 0.999. | N = 40. Samples spanned from 12 IU/L to 738 IU/L. The regression equation was y = 1.03x - 1.65 and r = 0.998. | # K. Standard/Guidance Document Referenced (if applicable): None referenced # L. Test Principle: Chemistry Basic 1, Calcium: Calcium in the sample is combined with $o$ -cresolphthalein complexone (OCPC) under strong alkaline conditions to form a purple chelate. $$ \mathrm {C a} ^ {2 +} + \mathrm {O C P C} \xrightarrow {\mathrm {O H}} \text {b l u e - p u r p l e c h r o m a g e n} $$ {6} The intensity of the blue chromagen as measured at 575 nm by reflectance spectrophotometry is directly proportional to the concentration of calcium in the patient sample. **Chemistry Basic 1, BUN:** Urea in the sample reacts with *o*-phthalaldehyde to produce 1,3-dihydroxyisoindoline (DHI). The carbonium ion of DHI reacts with *N*-1-naphthyl-*N*’-diethylethylenediamineoxalic acid under strong acidic conditions to form a blue purple color. Urea + *o*-phthalaldehyde + *N*-1-naphthyl-*N*’-diethylethylenediamineoxalic acid $\xrightarrow{\mathrm{H}^{+}}$ blue-purple chromagen The intensity of the blue chromagen as measured at 610 nm by reflectance spectrophotometry is directly proportional to the concentration of blood urea nitrogen in the patient sample. **Chemistry Basic 1, Glucose:** Glucose in the sample is oxidized in a concentration-dependent manner by glucose oxidase (GOD) found in the reagent layer. GOD oxidizes the glucose with the quantitative production of hydrogen peroxide. The hydrogen peroxide oxidizes and condenses 4-aminoantipyrine (4AAP) and 1-naphthol-3, 6-disulfonic acid disodium (NDD) by the catalytic action of peroxidase to form a reddish-purple color. $$ \begin{array}{l} \mathrm{Glucose} + \mathrm{O}_{2} + \mathrm{H}_{2}\mathrm{O} \xrightarrow{\mathrm{GOD}} \mathrm{D}\text{-gluconic acid} + \mathrm{H}_{2}\mathrm{O} \\ \mathrm{H}_{2}\mathrm{O}_{2} + 4\mathrm{AAP} + \mathrm{NDD} \xrightarrow{\mathrm{POD}} \text{reddish-purple chromagen} + \mathrm{H}_{2}\mathrm{O} \\ \end{array} $$ The intensity of the reddish-purple color measured at 550 nm by reflectance spectrophotometry is proportional to the concentration of glucose in the patient sample. **Chemistry Basic 1, Albumin:** Albumin in the sample is combined with bromcresol green (BCG) in acidic conditions to form a blue-green complex. $$ \mathrm{Albumin} + \text{bromcresol green} \xrightarrow{\mathrm{H}^{+}} \text{blue-green chromagen} $$ The intensity of the blue-green color, as measured at 610 nm by reflectance spectrophotometry, is proportional to the concentration of albumin in the patient sample. {7} Chemistry Basic 1, Creatinine: Creatinine in the sample is combined with 3, 5-dinitrobenzoic acid under alkaline conditions to form a red chromagen. $$ \text{Creatinine} + 3,5\text{-dinitrobenzoic acid} \xrightarrow{\text{OH}} \text{red chromagen} $$ The intensity of the red chromagen as measured at $550~\mathrm{nm}$ by reflectance spectrophotometry is directly proportional to the concentration of creatinine in the patient sample. Chemistry Basic 2, Total Bilirubin: Both indirect and direct bilirubin in the sample react with diazonium salt in the presence of dyphylline and an acidic buffer to form a red azobilirubin as a final product. $$ \text{Total bilirubin} + \text{sulfanilic acid} + \text{nitrite} \xrightarrow{\text{dyphylline}} \text{red azobilirubin} $$ The intensity of the red color, as measured at $550~\mathrm{nm}$ by reflectance spectrophotometry, is proportional to the concentration of total bilirubin in the patient sample. Chemistry Basic 2, Total Protein: Protein in serum or plasma reacts with copper ion at high pH to form a blue-purple color. $$ \text{Total protein} + \text{copper sulphate} \xrightarrow{\text{OH}} \text{blue-purple chromagen} $$ The intensity of the blue-purple color, as measured at $550~\mathrm{nm}$ by reflectance spectrophotometry, is proportional to the concentration of total protein in the patient sample. Chemistry Basic 2, ALP: ALP in the sample reacts with $p$-nitrophenylphosphate and hydrolyzes it to form $p$-nitrophenyl and phosphate. $$ p\text{-nitrophenylphosphate} + \mathrm{H_2O} \xrightarrow{\mathrm{ALP}} \text{phosphate} + p\text{-nitrophenyl} $$ The rate, at which the yellow color is generated, as measured at $405~\mathrm{nm}$ by reflectance spectrophotometry, is directly proportional to the ALP activity in the patient sample. Chemistry Basic 2, AST: AST in the sample transfers amino group of L-aspartic to $\alpha$-ketoglutaric acid to produce L-glutamic acid and oxalacetic acid. The pyruvic acid, in the presence of magnesium ion and thiamine pyrophosphoric acid, is oxidized by the catalytic action of pyruvate oxidase to produce hydrogen peroxide. The hydrogen {8} peroxide oxidizes and condenses 4-aminoantipyrine (4AAP) and DAOS by the catalytic action of peroxidase to form a blue color. $$ \begin{array}{l} \text{(absorbic acid + 1/2 O}_2 \xrightarrow{\text{AsOD}} \text{dehydroascorbic acid + H}_2\text{O} \\ \quad : \text{removal of ascorbic acid interference)} \end{array} $$ $$ \text{L-aspartic acid + α-ketoglutaric acid} \xrightarrow{\text{AST}} \text{L-glutamic acid + oxalacetic acid} $$ $$ \text{Oxalacetic acid} \xrightarrow{\text{OAC}} \text{pyruvate + CO}_2 $$ $$ \text{Pyruvic + phosphate + O}_2 \xrightarrow[\text{Mg}^{2+}]{\text{POP, TPP}} \text{acetylphosphoric acid + H}_2\text{O}_2 + \text{CO}_2 $$ $$ \text{H}_2\text{O}_2 + 4\text{AAP} + \text{DAOS} \xrightarrow{\text{POD}} \text{blue chromagen + H}_2\text{O} $$ The rate at which the blue color is generated in this detection layer as measured at $610\,\mathrm{nm}$ by reflectance spectrophotometry is proportional to the AST activity in plasma. **Chemistry Basic 2, ALT**: ALT in the sample transfers amino group of L-alanine to $\alpha$-ketoglutaric acid and produces L-glutamic acid and pyruvic acid. The pyruvic acid, in the presence of magnesium ion and thiamine pyrroline, is oxidized by the catalytic action of pyruvic acid oxidase, to produce hydrogen peroxide. The hydrogen peroxide oxidizes and condenses 4-aminoantipyrine (4AAP) and DAOS by the catalytic action of peroxidase to form a blue color. $$ \text{(absorbic acid + 1/2 O}_2 \xrightarrow{\text{AsOD}} \text{dehydroascorbic acid + H}_2\text{O}: $$ $$ \text{removal of ascorbic acid interference} $$ $$ \text{L-alanine + α-ketoglutaric acid} \xrightarrow{\text{ALT}} \text{L-glutamic acid + pyruvic acid} $$ $$ \text{Pyruvic acid + phosphate + O}_2 \xrightarrow[\text{Mg}^{2+}]{\text{POP, TPP}} \text{acetylphosphoric acid + H}_2\text{O}_2 + \text{CO}_2 $$ $$ \text{H}_2\text{O}_2 + 4\text{AAP} + \text{DAOS} \xrightarrow{\text{POD}} \text{blue chromagen + H}_2\text{O} $$ The rate at which the blue color is generated in this detection layer as measured at $610\,\mathrm{nm}$ by reflectance spectrophotometry is proportional to the ALT activity in plasma. After the completion of the measurement, the SPOTCHEM EZ SP-4430 Analyzer calculates the concentration of analyte [D] as follows: {9} $$ D = a \cdot (K / S) ^ {3} + b \cdot (K / S) ^ {2} + c \cdot (K / S) + d $$ Where (K/S) is the Kubelka-Munk value for reflectance and a, b, c and d are coefficients derived from the calibration curve. # M. Performance Characteristics (if/when applicable): # 1. Analytical performance: # a. Precision/Reproducibility: # Intra assay Precision Intra assay precisions (within run) were assessed by twenty replicates of the same sample within one analytical run with three levels evaluated. The mean, standard deviation (SD) and coefficient of variation (CV) in percent were also calculated. The data are presented in the Tables below. Intra Assay Precision for Chemistry Basic 1 | Analyzer SPOTCHEM EZ | | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | --- | | Analyte | n | 20 | 20 | 20 | | Calcium (mg/dL) | Mean | 8.00 | 10.46 | 12.41 | | | SD | 0.290 | 0.404 | 0.554 | | | %CV | 3.6% | 3.9% | 4.5% | | BUN (mg/dL) | Mean | 15.3 | 23.4 | 69.4 | | | SD | 0.47 | 0.67 | 2.30 | | | %CV | 3.1% | 2.9% | 3.3% | | Glucose (mg/dL) | Mean | 64.3 | 107.3 | 267.0 | | | SD | 0.73 | 2.49 | 8.71 | | | %CV | 1.1% | 2.3% | 3.3% | | Albumin (mg/L) | Mean | 2.47 | 4.90 | 5.30 | | | SD | 0.073 | 0.147 | 0.103 | | | %CV | 3.0% | 3.0% | 1.9% | | Creatinine (mg/dL) | Mean | 1.23 | 1.51 | 4.45 | | | SD | 0.055 | 0.060 | 0.076 | | | %CV | 4.5% | 4.0% | 1.7% | Intra Assay Precision for Chemistry Basic 2 | Analyzer SPOTCHEM EZ | | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | --- | | N | | 20 | 20 | 20 | | Total Bilirubin (mg/dL) | Mean SD %CV | 0.69 | 1.68 | 6.5 | | | | 0.031 | 0.062 | 0.266 | | | | 4.5% | 3.7% | 4.1% | | Total Protein (mg/L) | Mean SD %CV | 5.19 | 7.57 | 9.49 | | | | 0.107 | 0.232 | 0.290 | | | | 2.1% | 3.1% | 3.1% | {10} 11 | Analyzer SPOTCHEM EZ | | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | --- | | ALP (IU/L) | Mean | 59.7 | 223.6 | 431.2 | | | SD | 1.95 | 7.95 | 14.12 | | | %CV | 3.3% | 3.6% | 3.3% | | AST (IU/L) | Mean | 24.3 | 106.0 | 188.5 | | | SD | 0.97 | 3.65 | 6.53 | | | %CV | 4.0% | 3.4% | 3.5% | | ALT (IU/L) | Mean | 19.9 | 99.6 | 180.0 | | | SD | 0.99 | 2.72 | 3.46 | | | %CV | 5.0% | 2.7% | 1.9% | ## Intra assay Precision, Whole blood samples Intra assay precisions (within run) were assessed using a whole blood sample with ten replicates of the same sample within one analytical run. The mean, standard deviation (SD) and coefficient of variation (CV) in percent were calculated. The data are presented in the Table below. ## Intra Assay Precision with whole blood sample, N = 10 | Analyzer SPOTCHEM EZ | Mean | SD | %CV | | --- | --- | --- | --- | | Chemistry Basic 1, Calcium (mg/dL) | 11.52 | 0.220 | 1.9% | | Chemistry Basic 1, BUN (mg/dL) | 32.9 | 0.99 | 3.0% | | Chemistry Basic 1, Glucose (mg/dL) | 126.8 | 3.58 | 2.8% | | Chemistry Basic 1, Albumin (g/dL) | 5.37 | 0.263 | 4.9% | | Chemistry Basic 1, Creatinine (mg/dL) | 2.47 | 0.116 | 4.7% | | Chemistry Basic 2, Total Bilirubin (mg/dL) | 4.09 | 0.166 | 4.1% | | Chemistry Basic 2, Total Protein (g/dL) | 8.92 | 0.326 | 3.7% | | Chemistry Basic 2, ALP (IU/L) | 242.8 | 11.26 | 4.6% | | Chemistry Basic 2, AST (IU/L) | 49.7 | 1.49 | 3.0% | | Chemistry Basic 2, ALT (IU/L) | 69.8 | 3.26 | 4.7% | ## Inter Assay Precision Inter assay (between run) precisions were determined by analyzing duplicates of three different samples in each of ten different runs over ten different occasions. The data are presented in the Table below. ## Inter Assay Precision for Chemistry Basic 1 | Analyzer SPOTCHEM EZ | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | | Days | 5 | 5 | 5 | | N | 20 | 20 | 20 | {11} 12 | Analyzer SPOTCHEM EZ | | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | --- | | Calcium (mg/dL) | Mean | 7.88 | 10.08 | 12.30 | | | SD | 0.346 | 0.309 | 0.453 | | | %CV | 4.4% | 3.1% | 3.7% | | BUN (mg/dL) | Mean | 14.9 | 23.3 | 67.5 | | | SD | 0.45 | 0.85 | 1.88 | | | %CV | 3.0% | 3.7% | 2.8% | | Glucose (mg/dL) | Mean | 63.0 | 106.2 | 261.8 | | | SD | 1.52 | 3.91 | 9.45 | | | %CV | 2.4% | 3.7% | 3.6% | | Albumin (mg/L) | Mean | 2.45 | 4.84 | 5.31 | | | SD | 0.061 | 0.135 | 0.112 | | | %CV | 2.5% | 2.8% | 2.1% | | Creatinine (mg/dL) | Mean | 1.29 | 1.50 | 4.40 | | | SD | 0.091 | 0.069 | 0.110 | | | %CV | 7.1% | 4.6% | 2.5% | ## Inter Assay Precision for Chemistry Basic 2 | Analyzer SPOTCHEM EZ | | Level 1 | Level 2 | Level 3 | | --- | --- | --- | --- | --- | | | Days N | 5 | 5 | 5 | | | | 20 | 20 | 20 | | Total Bilirubin (mg/dL) | Mean SD %CV | 0.70 | 1.64 | 6.28 | | | | 0.000 | 0.088 | 0.231 | | | | 0.0% | 5.4% | 3.7% | | Total Protein (mg/L) | Mean SD %CV | 5.11 | 7.47 | 9.49 | | | | 0.137 | 0.237 | 0.323 | | | | 2.7% | 3.2% | 3.4% | | ALP (IU/L) | Mean SD %CV | 58.7 | 222.4 | 425.9 | | | | 1.79 | 5.65 | 16.60 | | | | 3.0% | 2.5% | 3.9% | | AST (IU/L) | Mean SD %CV | 24.8 | 107.0 | 180.4 | | | | 2.17 | 2.79 | 6.23 | | | | 8.8% | 2.6% | 3.5% | | ALT (IU/L) | Mean SD %CV | 20.6 | 103.2 | 173.2 | | | | 0.88 | 6.22 | 3.90 | | | | 4.3% | 6.0% | 2.3% | ## b. Linearity/assay reportable range: ### Linearity Studies The linearity/calibration curve fit data were generated for a pool that {12} spanned the linear range of the test. Serial dilution sets were prepared using 7% BSA and made up fresh and assayed with each of three calibrated runs. The results at each level of analyte were averaged and the linear fit was assessed. The sponsor claims that the linearity was based on a percent deviation of ≤ 5% at the two highest analyte concentrations. ## Chemistry Basic 1 Calcium: Calcium was found to be linear up to 16.9 mg/dL. The linear fit yielded a regression equation of Y = 1.20X - 1.33, R² = 0.991. BUN: BUN was found to be linear up to 169.7 mg/dL. The linear fit yielded a regression equation of Y = 1.03X - 1.18, R² = 0.9968. Glucose: Glucose was found to be linear up to 438 mg/dL. The linear fit yielded a regression equation of Y = 1.00X + 3.78, R² = 0.9987. Albumin: Albumin was found to be linear up to 6.6 g/dL. The linear fit yielded a regression equation of Y = 1.02X - 0.06, R² = 0.9956. Creatinine: Creatinine was found to be linear up to 37.9 mg/dL. The linear fit yielded a regression equation of Y = 0.98X - 0.06, R² = 0.9988. ## Chemistry Basic 2 ALP: ALP was found to be linear up to 859.3 IU/L. The linear fit yielded a regression equation of Y = 1.03X - 2.33, R² = 0.9988. Total Bilirubin: Total Bilirubin was found to be linear up to 16.4 g/dL. The linear fit yielded a regression equation of Y = 1.03X - 0.02, R² = 0.9973. Total Protein: Total Protein was found to be linear up to 10.7 g/dL. The linear fit yielded a regression equation of Y = 0.99X - 0.00, R² = 0.9964. AST: AST was found to be linear up to 733.7 IU/L. The linear fit yielded a regression equation of Y = 0.98X + 3.66, R² = 0.9975. ALT: ALT was found to be linear up to 860.3 IU/L. The linear fit yielded a regression equation of Y = 1.03X - 1.76, R² = 0.9995. c. Traceability, Stability, Expected values (controls, calibrators, or methods): ## Calibration The calibration set points are fixed by the manufacturer and are unique with each reagent lot and stored on a magnetic card provided with each kit lot. The principle of the calibration is to fix a two-point calibration curve for a given lot into the memory of the instrument. The sample absorbances are then read off this fixed curve by the instrument and the concentration is calculated and the results are provided by the software. 13 {13} 14 # Stability Summary The sponsor's stability claim was determined by an internal stability study SOP. Accordingly the initial shelf-life determinations were conducted by accelerated aging studies and backed up with real time aging studies. The shelf life of the test strip was conducted after exposure to real shipping conditions and labeled (standard) storage conditions. The sponsor's real time studies were conducted after performing baseline testing and study points were initiated at appropriate intervals during real time aging under labeled standard storage conditions, or to the nearest time point that is 25% beyond the claimed or desired shelf-life. The sponsor concluded from these studies that the reagent strips are stable through the labeled expiration date when stored at 2-8°C. ## d. Detection limit: The sponsor determined the minimum detectable value with an acceptable level of precision by diluting a pool to 10 different concentrations below the lower limit of the normal test range for each analyte. Each dilution was then assayed in replicates of ten. The mean, standard deviation and percent coefficient of variation were calculated for the ten replicates of each dilution. The defined results for each test are summarized below: | Test | Sensitivity | %CV | | --- | --- | --- | | Calcium | 4.9 mg/dL | 3.3% | | BUN | 6.6 mg/dL | 7.8% | | Glucose | 27 mg/dL | 0.0% | | Albumin | 0.6 g/dL | 0.0% | | Creatinine | 0.66 mg/dL | 7.8% | | ALP | 25.4 IU/L | 2.8% | | Total Bilirubin | 0.3 mg/dL | 0.0% | | Total Protein | 2.7 g/dL | 2.5% | | AST | 10 IU/L | 0.0% | | ALT | 12 IU/L | 6.7% | ## e. Analytical specificity: ### Interference substances studies The sponsor's acceptance criteria for determining common interference substances were that the acceptable established analyte recovery should not vary from the base recovery by less or more than 10%. The interfering {14} substances were evaluated in serum pools that had target analyte levels below normal, in the normal range, and above the normal range. A summary of the data for known interferents appears in the table below. ## Chemistry Basic 1 Interfering Substances | | Calcium* | BUN | Glucose | Albumin | Creatinine | | --- | --- | --- | --- | --- | --- | | Sample | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference | | Hemoglobin | 300 mg/dL | 300 mg/dL | 150 mg/dL | 150 mg/dL | 300 mg/dL | | Bilirubin | 11.8 mg/dL | 12.0 mg/dL | 9.0 mg/dL | 7.63 mg/dL | 15.21 mg/dL | | Triglycerides | 394 mg/dL | 285 mg/dL | 200 mg/dL | 436.1 mg/dL | 285 mg/dL | *Calcium: Also, no interference was observed up to a level of 5.3 mg/dL magnesium. ## Chemistry Basic 2 Interfering Substances | | ALP | Total Bilirubin | Total Protein | AST | ALT | | --- | --- | --- | --- | --- | --- | | Sample | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference | | Hemoglobin | 250 mg/dL | 150 mg/dL | 300 mg/dL | 100 mg/dL | 100 mg/dL | | Bilirubin | 7.6 mg/dL | NA | 7.6 mg/dL | 1.5 mg/dL | 2.0 mg/dL | | Triglycerides | 423 mg/dL | 302 mg/dL | 334.6 mg/dL | 200 mg/dL | 150 mg/dL | f. Assay cut-off: Not applicable for this type of device. 2. Comparison studies: a. Method comparison with predicate device: The sponsor performed correlation studies by comparing the Panel test results {15} generated on the SPOTCHEM EZ analyzer (SP-4430)against the results generated from predicate device. ## Chemistry Basic 1 Calcium: The 40 serum samples spanned from 5.1 mg/dL to 15.2 mg/dL. The regression equation was y = 0.97x + 0.14 and r = 0.9927. BUN: The 40 serum samples spanned from 7 mg/dL to 92 mg/dL. The regression equation was y = 1.08x - 0.43 and r = 0.9972. Glucose: The 40 serum samples spanned from 30 mg/dL to 406 mg/dL. The regression equation was y = 1.07x - 7.19 and r = 0.9970. Albumin: The 40 serum samples spanned from 1.9 g/dL to 5.8 g/dL. The regression equation was y = 0.99x + 0.07 and r = 0.9763. Creatinine: The 40 serum samples spanned from 0.7 mg/dL to 15.3 mg/dL. The regression equation was y = 1.07x - 0.00 and r = 0.9972. ## Chemistry Basic 2 ALP: The 40 serum samples spanned from 62 IU/L to 685 IU/L. The regression equation was y = 1.04x - 9.34 and r = 0.9984. Total Bilirubin: The 40 serum samples spanned from 0.3 mg/dL to 8.7 mg/dL. The regression equation was y = 1.00x - 0.09 and r = 0.9986. Total Protein: The 40 serum samples spanned from 3.3 g/dL to 10.4 g/dL. The regression equation was y = 0.98x - 0.03 and r = 0.9863. AST: The 40 serum samples spanned from 11 IU/L to 267 IU/L. The regression equation was y = 0.95x + 2.62 and r = 0.9991. ALT: The 40 serum samples spanned from 12 IU/L to 738 IU/L. The regression equation was y = 1.03x - 1.65 and r = 0.9980. ## b. Matrix comparison: The sponsor presented the below correlation studies comparing test results generated on the SPOTCHEM EZ SP-4430 analyzer for the specimen types of serum and whole blood. ## Chemistry Basic 1 (Serum and Whole Blood) Calcium: Twenty-two matched serum and whole blood samples were analyzed. The regression equation for the 22 serum and whole blood samples was y = 1.01x - 0.05 and r = 0.9437. The summary of the correlation data is presented in the table below. 16 {16} Correlation Data Summary for Chemistry Basic 1 Calcium in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 8.132 | 1.322 | 0.9437 | 0.8906 | 7.0 | 12.9 | 22 | | Whole blood | 8.136 | 1.410 | | | 6.5 | 12.5 | | BUN: Twenty-three matched serum and whole blood samples were analyzed. The regression equation for the 23 serum and whole blood samples was $y = 1.01x - 0.60$ and $r = 0.9972$. The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 1 BUN in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 18.957 | 21.242 | 0.9972 | 0.9944 | 8.0 | 102 | 23 | | Whole blood | 18.522 | 21.492 | | | 7.0 | 106 | | Glucose: Twenty-two matched serum and whole blood samples were analyzed. The regression equation for the 22 serum and whole blood samples was $y = 0.98x + 4.24$ and $r = 0.9937$. The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 1 Glucose in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 90.955 | 38.745 | 0.9937 | 0.9875 | 41 | 221 | 22 | | Whole blood | 93.818 | 38.401 | | | 45 | 219 | | Albumin: Twenty-two matched serum and whole blood samples were analyzed. The regression equation for the 22 serum and whole blood samples was $y = 0.93x + 0.61$ and $r = 0.9476$. The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 1 Albumin in g/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 4.191 | 0.732 | 0.9476 | 0.8980 | 1.6 | 5.4 | 22 | | Whole blood | 4.518 | 0.721 | | | 1.8 | 5.4 | | Creatinine: Twenty-one matched serum and whole blood samples were analyzed. The regression equation for the 21 serum and whole blood samples was $y = 0.96x + 0.04$ and $r = 0.9997$. The summary of the correlation data is presented in the table below. {17} Correlation Data Summary for Chemistry Basic 1 Creatinine in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 1.667 | 2.785 | 0.9997 | 0.9995 | 0.9 | 13.8 | 21 | | Whole blood | 1.643 | 2.676 | | | 0.8 | 13.8 | | # Chemistry Basic 2 (Serum and Whole Blood) ALP: Twenty-one matched serum and whole blood samples were analyzed. The regression equation for the 21 serum and whole blood samples was $y = 1.02x + 1.67$ and $r = 0.9965$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 ALP in IU/L. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 117.286 | 65.275 | 0.9965 | 0.9929 | 48 | 244 | 21 | | Whole blood | 121.238 | 66.784 | | | 51 | 251 | | Total Bilirubin: Twenty matched serum and whole blood samples were analyzed. The regression equation for the 20 serum and whole blood samples was $y = 0.99x - 0.03$ and $r = 0.9900$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 T. Bilirubin in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 0.635 | 0.415 | 0.9900 | 0.9801 | 0.3 | 1.8 | 20 | | Whole blood | 0.600 | 0.415 | | | 0.3 | 1.8 | | Total Protein: Twenty-two matched serum and whole blood samples were analyzed. The regression equation for the 22 serum and whole blood samples was $y = 0.95x + 0.56$ and $r = 0.9670$ . The summary of the correlation data is presented in the below table. Correlation Data Summary for Chemistry Basic 2 Total Protein in g/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 7.300 | 1.280 | 0.9670 | 0.9351 | 3.1 | 8.4 | 22 | | Whole blood | 7.477 | 1.254 | | | 3.6 | 8.8 | | {18} AST: Twenty matched serum and whole blood samples were analyzed. The regression equation for the 20 serum and whole blood samples was $y = 0.96x + 0.15$ and $r = 0.9958$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 AST. Results in IU/L. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 35.9 | 35.105 | 0.9958 | 0.9916 | 12 | 166 | 20 | | Whole blood | 34.7 | 33.975 | | | 11 | 156 | | ALT: Twenty matched serum and whole blood samples were analyzed. The regression equation for the 20 serum and whole blood samples was $y = 0.99x + 0.39$ and $r = 0.9986$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 ALT. Results in IU/L. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Serum | 45.200 | 46.616 | 0.9986 | 0.9973 | 12 | 220 | 20 | | Whole blood | 45.050 | 46.118 | | | 12 | 217 | | The sponsor presented correlation studies comparing test results generated on the SPOTCHEM EZ SP-4430 analyzer for the specimen types of plasma and whole blood. The results are presented below. # Chemistry Basic 1 (Plasma and Whole Blood) Calcium: Twenty-one matched plasma and whole blood samples were analyzed. The regression equation for the 21 plasma and whole blood samples was $y = 1.06x - 0.42$ and $r = 0.9702$ . The summary of the correlation data is presented in the below table. Correlation Data Summary for Chemistry Basic 1 Calcium in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 7.848 | 0.953 | 0.9702 | 0.9413 | 6.9 | 11.4 | 21 | | Whole blood | 7.929 | 1.044 | | | 6.5 | 11.7 | | BUN: Twenty-two matched plasma and whole blood samples were analyzed. The regression equation for the 22 plasma and whole blood samples was $y = 0.93x + 0.78$ and $r = 0.9969$ . The summary of the correlation data is presented in the table below. {19} Correlation Data Summary for Chemistry Basic 1 BUN in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 14.591 | 9.106 | 0.9969 | 0.9938 | 8.0 | 52 | 22 | | Whole blood | 14.318 | 8.476 | | | 8.0 | 49 | | Glucose: Twenty-two matched plasma and whole blood samples were analyzed. The regression equation for the 22 plasma and whole blood samples was $y = 1.00x + 0.98$ and $r = 0.9940$. The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 1 Glucose in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 92.636 | 38.017 | 0.9940 | 0.9880 | 42 | 219 | 22 | | Whole blood | 93.864 | 38.348 | | | 45 | 219 | | Albumin: Twenty-two matched plasma and whole blood samples were analyzed. The regression equation for the 22 plasma and whole blood samples was $y = 1.01x + 0.09$ and $r = 0.9574$. The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 1 Albumin in g/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 4.359 | 0.747 | 0.9574 | 0.9166 | 1.4 | 5.2 | 22 | | Whole blood | 4.495 | 0.789 | | | 1.4 | 5.3 | | Creatinine: Twenty-one matched plasma and whole blood samples were analyzed. The regression equation for the 21 plasma and whole blood samples was $y = 1.02x - 0.02$ and $r = 0.9997$. The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 1 Creatinine in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r² | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 1.686 | 2.895 | 0.9997 | 0.9994 | 0.8 | 14.3 | 21 | | Whole blood | 1.705 | 2.959 | | | 0.8 | 14.6 | | ## Chemistry Basic 2 (Plasma and Whole Blood) ALP: Twenty-one matched plasma and whole blood samples were analyzed. The regression equation for the 21 plasma and whole blood samples was $y =$ 20 {20} $0.97\mathrm{x} + 2.96$ and $\mathrm{r} = 0.9971$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 ALP. Results in IU/L. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 126.905 | 72.506 | 0.9971 | 0.9942 | 51 | 253 | 21 | | Whole blood | 126.429 | 70.751 | | | 51 | 251 | | Total Bilirubin: Twenty matched plasma and whole blood samples were analyzed. The regression equation for the 20 plasma and whole blood samples was $y = 0.97x + 0.01$ and $r = 0.9908$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 T. Bilirubin in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 0.605 | 0.406 | 0.9908 | 0.9817 | 0.3 | 1.6 | 20 | | Whole blood | 0.595 | 0.395 | | | 0.3 | 1.5 | | Total Protein: Twenty-one matched plasma and whole blood samples were analyzed. The regression equation for the 21 plasma and whole blood samples was $y = 1.03x + 0.19$ and $r = 0.9699$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 T. Protein in mg/dL. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 7.586 | 1.050 | 0.9699 | 0.9406 | 3.4 | 8.6 | 21 | | Whole blood | 7.600 | 1.112 | | | 3.3 | 8.8 | | AST: Twenty matched plasma and whole blood samples were analyzed. The regression equation for the 20 plasma and whole blood samples was $y = 1.04x - 3.91$ and $r = 0.9973$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 AST in IU/L. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 36.300 | 31.787 | 0.9973 | 0.9946 | 12 | 150 | 20 | | Whole blood | 34.000 | 33.291 | | | 11 | 156 | | {21} ALT: Twenty matched plasma and whole blood samples were analyzed. The regression equation for the 20 plasma and whole blood samples was $y = 1.02x - 0.57$ and $r = 0.9991$ . The summary of the correlation data is presented in the table below. Correlation Data Summary for Chemistry Basic 2 ALT in IU/L. | Variable X,Y | Mean | Std. Dv. | r(X,Y) | r2 | Min. | Max. | N | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma | 45.900 | 46.057 | 0.9991 | 0.9982 | 12 | 214 | 20 | | Whole blood | 46.050 | 46.824 | | | 12 | 217 | | # 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 expected ranges presented in the proposed package insert were established from scientific literature with references listed below: 1. Henry, J.B., Clinical Diagnosis and Management by Laboratory Methods $20^{\text{th}}$ ed. W.B. Saunders Co., Philadelphia (1976). 2. Tietz, N.W. Textbook of Clinical Chemistry $2^{\mathrm{nd}}$ ed. W.B. Saunders Co., Philadelphia (1994). The normal values for each of the tests are listed in the tables below: # Chemistry Basic 1 Adult Calcium Levels in Serum | Specimen Type | mg/dL | mmol/L | | --- | --- | --- | | Adult | 8.10 - 10.4 | 2.02 - 2.60 | {22} Adult Urea Nitrogen Levels in Serum | Specimen Type | Mg/dL | mmol/L | | --- | --- | --- | | Adult | 8 - 20 | 2.9 – 7.1 | Adult Glucose Levels in Serum | Impaired Fasting Glucose | Diabetic | Unit | | --- | --- | --- | | 110 – 126 | > 126 | mg/dL | | 6.1 – 7.0 | > 7.0 | mmol/L | Adult Albumin Levels in Serum | Specimen Type | g/dL | g/L | | --- | --- | --- | | Serum | 3.5 – 5.0 | 35 – 50 | Adult Creatinine Levels in Serum | Specimen Type | mg/dL | mol/L | | --- | --- | --- | | Adult male | 0.7 – 1.3 | 62 – 115 | | Adult female | 0.6 – 1.1 | 53 – 97 | ## Chemistry Basic 2 Adult ALP Levels in Serum | Specimen Type | IU/L | kit/L | | --- | --- | --- | | Adult (at 37°C) | 40 - 150 | 0.67 – 2.50 | Adult Total Bilirubin Levels in Serum | Specimen Type | mg/dL | mmol/L | | --- | --- | --- | | Serum | 0.2 – 1.0 | 3.4 – 17.1 | Adult Total Protein Levels in Serum | Specimen Type | g/dL | g/L | | --- | --- | --- | | Serum | 6.0 – 7.8 | 60 – 78 | {23} Adult ALT Levels in Serum (25°C) | Specimen Type | IU/L | kit/L | | --- | --- | --- | | Adult male | Up to 22 | Up to 0.37 | | Adult female | Up to 17 | Up to 0.28 | Adult AST Levels in Serum | Specimen Type | IU/L | kit/L | | --- | --- | --- | | Adult male | 15 – 40 | 0.25 – 0.67 | | Adult female | 13 – 35 | 0.22 – 0.58 | N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 24