DATAPRO CLINICAL CHELISTRY ANALYZER

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k042767 B. Purpose for Submission: Thermo Electron Corporation proposes to manufacture and introduce into interstate commerce, for commercial distribution, the Thermo Electron DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer. This is being submitted for use with previously FDA cleared reagents manufactured by Trace and/or DMA, now doing business as Thermo Electron Corporation. C. Measurand: Glucose, Alkaline phosphatase, Albumin, Aspartate amino transferase (AST/SGOT), Bilirubin total, Bilirubin direct, Calcium, Creatinine, Urea nitrogen, Total protein, Phosphorus, Cholesterol, Triglyceride, Uric acid, Alanine amino transferase (ALT/SGPT). D. Type of Test: Quantitative assays for the DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer E. Applicant: Thermo Electron Corporation F. Proprietary and Established Names: DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer G. Regulatory Information: 1. Regulation section: 21 CFR § 862.1345 Glucose test system. 21 CFR § 862.1050 Alkaline phosphatase or isoenzymes test system. 21 CFR § 862.1035 Albumin test system. 21 CFR § 862.1100 Aspartate amino transferase (AST/SGOT) test system. 21 CFR § 862.1110 Bilirubin (total or direct) test system. 21 CFR § 862.1110 Bilirubin (total or direct) test system. 21 CFR § 862.1145 Calcium test system. 21 CFR § 862.1225 Creatinine test system. 21 CFR § 862.1770 Urea nitrogen test system. 21 CFR § 862.1635 Total protein test system. 21 CFR § 862.1580 Phosphorus (inorganic) test system. 21 CFR § 862.1175 Cholesterol (total) test system. 21 CFR § 862.1705 Triglyceride test system. 21 CFR § 862.1775 Uric acid test system. 21 CFR § 862.1030 Alanine amino transferase (ALT/SGPT) test system. 21 CFR § 862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use {1} 2. Classification: Class II, Class I (reserved), Class I 3. Product code: PC Common Name CFR HEXOKINASE, GLUCOSE NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR CJE ISOENZYMES CIX BROMCRESOL GREEN DYE-BINDING, ALBUMIN CIT NADH OXIDATION/NAD REDUCTION, AST/SGOT CIG DIAZO COLORIMETRY, BILIRUBIN CIC CRESOLPHTHALEIN COMPLEXONE, CALCIUM CGX ALKALINE PICRATE, COLORIMETRY, CREATININE CDQ UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CEK BIURET (COLORIMETRIC), TOTAL PROTEIN CEO PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL CDT LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES CDO ACID, URIC, URICASE (U.V.) CKA NADH OXIDATION/NAD REDUCTION, ALT/SGPT 4 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL JJE USE Panel: Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories. The DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BUN), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Bilirubin, Total Protein, Triglyceride, and Uric Acid. {2} 3. Special conditions for use statement(s): The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only. 4. Special instrument requirements: DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer I. Device Description: The DataPro™/DataPro Plus™ (with cuvette washer) is a random access discrete photometric analyzer, capable of performing 48 different tests to 48 samples in a walk-away manner. In Clinical analysis, its purpose is for In Vitro Diagnostics. It performs Laboratory Chemistry Analysis in automated and selective form, either in routine or Stat mode. The analyzer incorporates robotics, computer and communication technology to render simple and reliable long-term operation. The DataPro™ consists of a system of modules (reagent tray, sampling system and reaction tray) performing specific functions, computer controlled and with bi-directional communication. Cuvettes are disposable and not for reuse, except where a washer is installed and enabled. Washing occurs automatically after the completion of each run. When the washer is in use, at the beginning of the next run, the system will use the next set of cuvettes after the ones used in the previous run. This prevents over use of the same cuvettes. Precision data were generated using this option at one test site compared to two other sites. Colors of the cuvettes in the Reaction Tray field are coded as follows: - Dark Grey: New cuvettes. - Light Grey: Used, then washed cuvettes (when washer installed). - Black: The checked absorbance of the empty cuvette is higher than the limit specified in the parameters. It is therefore considered dirty and will not be used. It is washed (where applicable) in the next run. If washing doesn't help, change the cuvette. For more detailed information see section O. System Descriptions below. J. Substantial Equivalence Information: 1. Predicate device name(s): Trace America, Inc reagents as follows: Glucose (HK), Alkaline Phosphatase, Albumin Reagent - Bromcresol Green Method, AST Incorporating Dynamic Stabilization Technology (DST), Direct Bilirubin Reagent - Acid Diazo Method, Total/Direct Bilirubin Reagent, Calcium Arsenazo III Reagent, Creatinine Reagent - Picric Acid Method, Urea (Urea Nitrogen) - Incorporating DST, Total Protein Reagent - Biuret Method, Phosphorus Reagent-Direct UV Method, {3} Cholesterol- Incorporating DST, Enzymatic Triglycerides Reagent, Uric Acid Incorporating DST, and ALT Incorporating DST. Ciba Corning Diagnostics Corp., Model 550 Express Clinical Chemistry Analyzer 2. Predicate 510(k) number(s): k980026, k012518, k870372, k961114, k870365, k911866, k903896, k870366, k971477, k870371, k870368, k962890, k860730, k971485, k961123, k872302 respectively as listed above. 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Reagents | Same | Same | | Analyzer | | | | • Discrete Photometric Analyzer | Same | Same | | • Software Driven | Same | Same | | • For clinical laboratory professionals | Same | Same | | • Automated dilutions | Same | Same | | • Sample reruns | Same | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Reagents | Automation on | Generic | | Testing Process | DataPro™ Analyzer | reagent/replacement reagents | | Analyzer | DataPro™ Analyzer | 550 Express Analyzer | | | | | K. Standard/Guidance Document Referenced (if applicable): All data was collected and statistical analysis for all methods performed according to National Committee of Clinical Laboratory Standards (NCCLS now CLSI) by standards such as: EP5 - Evaluation of Precision Performance of Clinical Chemistry Devices EP6 - Evaluation of the Linearity of Quantitative Analytical Methods EP9 - Method Comparison and Bias Estimation Using Patient Samples L. Test Principle: The package insert for each analyte states the test principle. {4} # M. Performance Characteristics (if/when applicable): # 1. Analytical performance: a. Precision/Reproducibility: Precision was performed per - CLSI Precision Standard, EP5. The results are presented below. | | | | Total | | With in run | | | --- | --- | --- | --- | --- | --- | --- | | Level | Assay | Mean | SD | CV(%) | SD | CV(%) | | I | Glu | 93 | 8.4 | 9.4 | 3.5 | 3.9 | | II | Glu | 300 | 16.5 | 5.9 | 11.4 | 4.1 | | I | ALP | 95 | 3.3 | 3.3 | 1.9 | 1.9 | | II | ALP | 483 | 15.0 | 3.3 | 7.2 | 1.6 | | I | ALB | 3.0 | 0.12 | 3.9 | 0.09 | 3.0 | | II | ALB | 2.2 | 0.08 | 2.1 | 0.05 | 2.1 | | I | AST | 29 | 1.1 | 3.9 | 0.8 | 1.0 | | II | AST | 176 | 5.6 | 3.2 | 1.8 | 1.0 | | I | T. Bili | 1.1 | 0.06 | 5.6 | 0.04 | 3.8 | | II | T. Bili | 7.1 | 0.17 | 2.4 | 0.07 | 1.0 | | I | D. Bili | 0.7 | 0.10 | 15.2 | 0.03 | 4.6 | | II | D. Bili | 3.3 | 0.26 | 8.1 | 0.06 | 1.8 | | I | Ca | 8.6 | 0.22 | 2.5 | 0.16 | 1.9 | | II | Ca | 13.5 | 0.24 | 1.9 | 0.16 | 1.2 | | I | Creat | 3.0 | 0.10 | 3.0 | 0.08 | 2.5 | | II | Creat | 6.7 | 0.20 | 2.8 | 0.15 | 2.1 | | I | BUN | 14 | 1.0 | 8.5 | 0.8 | 6.6 | | II | BUN | 54 | 3.4 | 7.6 | 2.2 | 4.9 | | I | T. Prot | 6.9 | 0.29 | 4.1 | 0.19 | 2.6 | | II | T. Prot | 5.2 | 0.22 | 0.22 | 0.11 | 2.0 | | I | Phos | 3.6 | 0.09 | 2.7 | 0.07 | 1.9 | | II | Phos | 6.8 | 0.32 | 4.6 | 0.11 | 1.6 | | I | Chol | 144 | 5.1 | 3.5 | 3.8 | 2.6 | | II | Chol | 250 | 11.4 | 4.5 | 6.9 | 2.7 | | I | Trig | 80 | 4.6 | 5.8 | 3.5 | 4.4 | | II | Trig | 142 | 7.8 | 5.6 | 5.9 | 4.2 | | I | UA | 6.2 | 0.18 | 3.0 | 0.09 | 1.4 | | II | UA | 12.0 | 0.26 | 2.3 | 0.08 | 0.7 | | I | ALT | 25 | 1.0 | 3.9 | 0.8 | 3.1 | | II | ALT | 88 | 3.9 | 3.9 | 2.5 | 2.4 | {5} | Cuvette Wash Option Precision Study | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site | Level | Assay | Mean | Total | | Between run | | | | | | | SD | CV(%) | SD | CV(%) | | 1 | I | T. Prot | 4.47 | 0.28 | 6.2 | 0.17 | 3.8 | | 1 | II | T. Prot | 3.32 | 0.21 | 6.4 | 0.11 | 3.4 | | 2 | I | T. Prot | 4.45 | 0.11 | 2.5 | 0.11 | 2.5 | | 2 | II | T. Prot | 3.29 | 0.10 | 3.1 | 0.10 | 3.1 | | C/Wash | I | T. Prot | 4.41 | 0.12 | 2.7 | 0.12 | 2.7 | | C/Wash | II | T. Prot | 3.24 | 0.09 | 2.9 | 0.09 | 2.9 | b. Linearity/assay reportable range: Linearity was performed per - CLSI Linearity Standard, EP6. The results are presented below. | Analyte | N | Slope | Intercept | % Error | Allowable % Error | Range | | --- | --- | --- | --- | --- | --- | --- | | Glucose | 11 | 1.020 | -0.6 | 2.6 | 3.0 | 0 – 788 mg/dL | | ALP | 6 | 0.926 | 4.7 | 7.1 | 7.5 | 10 – 2079 U/L | | ALB | 6 | 0.959 | 0.082 | 2.1 | 2.5 | 0 - 6.71 g/L | | AST | 5 | 0.974 | 0.0 | 2.6 | 5.0 | 7 – 1334 U/L | | TBILI | 6 | 1.014 | 0.03 | 1.7 | 5.0 | 0 - 20.5 mg/dL | | DBIL | 5 | 0.987 | 0.0 | 2.8 | 5.0 | 0 – 20 mg/dL | | CAL | 5 | 0.965 | -0.013 | 0.16 mg/dL | 0.25 mg/dL | 5 – 15 mg/dL | | CREA | 11 | 1.000 | 0.03 | 3.6 | 3.8 | 0 - 26.2 mg/dL | | BUN | 6 | 1.007 | 0.0 | 3.0 | 3.6 | 0 – 128 mg/dL | | TPRO | 10 | 0.977 | 0.1 | 2.3 | 2.5 | 0 - 17.3 g/L | | PHOS | 5 | 1.084 | -0.1 | 2.3 | 2.7 | 1 – 11 mg/dL | | CHOL | 11 | 1.017 | 0.0 | 2.7 | 3 | 0 - 904.9 mg/dL | | TRIG | 10 | 1.018 | 0.0 | 2.8 | 6.3 | 0 – 1277 mg/dL | | UA | 5 | 0.998 | -0.23 | 2.1 | 4.3 | 2 – 22 mg/dL | | ALT | 6 | 0.993 | 1.9 | 4.9 | 5.0 | 0 – 545 U/L | c. Traceability, Stability, Expected values (controls, calibrators, or methods): See the package insert for each analyte. d. Detection limit: See the package insert for each analyte. e. Analytical specificity: See the package insert for each analyte. {6} f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: The method comparison was performed per - CLSI Method Comparison Standard, EP9. The results are presented below. | Analyte | N | Slope | Intercept | Corr. R | Sample Range | | --- | --- | --- | --- | --- | --- | | Glucose | 60 | 0.935 | -0.2 | 0.9797 | 8 – 220 mg/dL | | ALP | 60 | 0.94 | -4.2 | 0.9922 | 40 – 516 U/L | | ALB | 60 | 0.9 | 0.28 | 0.9254 | 2.2 – 5.5 g/L | | AST | 55 | 0.97 | -1.7 | 0.9732 | 8 – 90 U/L | | TBILI | 40 | 1.195 | -0.1 | 0.9411 | 0.0 – 1.6 mg/dL | | DBIL | 40 | 0.891 | 0.15 | 0.9785 | 0.0 – 1.7 mg/dL | | CAL | 60 | 0.942 | 0.42 | 0.9288 | 5.6 – 13.3 mg/dL | | CREA | 59 | 0.995 | 0.14 | 0.988 | 0.2 – 7.1 mg/dL | | BUN | 59 | 1 | 0.18 | 0.9875 | 2.2 – 36.1 mg/dL | | TPRO | 40 | 1.047 | -0.05 | 0.9952 | 0.4 – 14.3 g/L | | PHOS | 60 | 1.17 | -0.422 | 0.9758 | 2.7 – 8.7 mg/dL | | CHOL | 60 | 1.068 | -9.3 | 0.9671 | 108 – 284 mg/dL | | TRIG | 60 | 1.044 | 21.7 | 0.9404 | 27 – 343 mg/dL | | UA | 60 | 0.901 | 0.164 | 0.9769 | 2.2 – 13.1 mg/dL | | ALT | 60 | 0.96 | -0.9 | 0.9914 | 6 – 120 U/L | b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable {7} 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: See the package insert for each analyte. N. Instrument Name: Thermo Electron DataPro™ / DataPro Plus™ Clinical Chemistry Analyzer O. System Descriptions: 1. Modes of Operation: - Profiles, batches, STAT procedures. - Automatic time adjust and dilution with high substrate consumption. - Automatic dilution for values above high limit. - Automatic repetition on abnormal low values. 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 option 4. Specimen Sampling and Handling: Sampling - 48 Sample positions in a rotary tray. - Use primary or pediatric tubes. - Bar code reader for sample identification (Optional). - Sample volume programmable 2 - 100 μL. - Pre-heater in the probe delivers reagent at the preset temperature. - Capacitive Level Sensor. - Inner and outer probe washing system. - CavroTM diluter syringe with valve assembly. Reagent Tray - 48 Reagent positions (Cooled in the Plus model). - Reagent volume Limits programmable: - In 0.6cm Cuvette First Reagent Volume 0 - 700 μL Second Reagent Volume 0 - 450 μL Minimum Volume 200 μL Maximum Volume 700 μL 8 {8} Total Volume (Sample + R1 + R2) 200 - 700 μL - Reagents are placed into wedge shaped vials: 45 mL, 30 mL or 18 mL, which can be used in any combination of single or two part reagent systems. **Reaction Tray** - Eighty (80) cuvette capacity. - Double beam, Interferential filters. - Wavelengths: 340, 380, 405, 450, 505, 550, 600, 650 and 700 nm. - Bandwidth: 10 nm. - Photometric range: -0.1 to 3.6 A (-0.1 to 5.5 A with 0.6 cm cuvettes). - Lamp: Halogen, 6 volts, 20 watts. 5. **Calibration:** - End point with sample blank or reagent blank. - Calibration by Factor or Standard. - Priority programmable per sample (profile) or reagent (batch). - Calibration curves with two (2) to ten (10) standards. - Automatic curve adjust. - Fast and Two-Point Kinetics (0 and 1st order). 6. **Quality Control:** - Levy Jennings plots, Westgard rules. - Data import and export to other programs and/or remote terminals. - Automatic backup protection **P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:** Software documentation provided demonstrates the DataPro™ / DataPro Plus™ Analyzer was designed and manufactured under well developed software lifecycle processes. **Q. Proposed Labeling:** The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. **R. Conclusion:** The submitted information in this premarket notification is complete and supports a substantial equivalence decision.