UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

{0} # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k103842 B. Purpose for Submission: Beckman Coulter is seeking clearance for UniCel® DxC 800 SYNCHRON® Clinical Systems Software Version 5.0, a modification to an existing device. Totality of changes since the original submission for, DxC 600 &amp; DxC 800 SYNCHRON software in k060256 was assessed, and the applicant determined changes after software version 4.9 needed a new 510(k) submission. C. Measurand: Glucose D. Type of Test: Quantitative – oxygen rate electrode measurement E. Applicant: Beckman Coulter, Inc. F. Proprietary and Established Names: UniCel DxC 800 SYNCHRON System Software Version 5.0 G. Regulatory Information: 1. Regulation section: 21CFR Sec.- 862.1345 Glucose test system. 21CFR Sec.- 862.2160-Discrete photometric chemistry analyzer for clinical use. 2. Classification: II, I respectively 3. Product code: CGA - Glucose Oxidase, Glucose JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 4. Panel: CH H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2. Indication(s) for use: The UniCel DxC 800 System Software Version 5.0 is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose. {1} SYNCHRON Systems Glucose (GLUCm) Reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. 3. Special conditions for use statement(s): Prescription use 4. Special instrument requirements: UniCel DxC 800 System Software Version 5.0 I. Device Description: The 800 SYNCHRON® System equipped with Software Version 5.0 is a member of the SYNCHRON family of clinical chemistry analyzers, manufactured and distributed by Beckman Coulter, Inc. The SYNCHRON instrument family includes the SYNCHRON CX Clinical Chemistry Systems and the SYNCHRON LX Clinical Chemistry Systems. The UniCel DxC Systems feature bar code identification of samples and reagents, Closed Tube Sampling, Obstruction Detection and Correction, and a dual carousel reagent storage compartment. Major system components include sample and reagent handling systems, bar code readers, modular chemistry sections, cartridge chemistry systems, and reagent storage compartment, supported by power and hydropneumatic utilities. J. Substantial Equivalence Information: 1. Predicate device name(s): DXC 600 &amp; DXC 800 Synchron software version 1.4 2. Predicate 510(k) number(s): k060256 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device UniCel DxC 800 SYNCHRON System Software Version 5.0 | Predicate k060256 | | Indication for use | System is a fully automated, computer-controlled clinical chemistry analyzers intended for the in vitro | Same | {2} | Similarities | | | | --- | --- | --- | | Item | Device UniCel DxC 800 SYNCHRON System Software Version 5.0 | Predicate k060256 | | | determination of a variety of cleared clinical laboratory assays | | | ·Fundamental Technologies ·Operational Environment ·System Architecture ·Optics/Reaction Subsystem ·Sample Handling Subsystem ·Chemistry Databases ·Reagents and Consumables | Same | Same | | Differences | | | | --- | --- | --- | | Item | Device UniCel DxC SYNCHRON Systems Software Version 5.0 | Predicate k060256 | | Data download and storage | Incorporate the use of the Universal Serial Bus (USB) to allow flexible Media download and storage capability. | No USB | | Printing lab report | Allow more than one lab report to be printed per page. | One report per page | | Result query | Results can now be retrieved by Patient Name. | No Patient Name look up | | Printer options | Add Network printer capability. | Only local printer | | Glucose Cup Module | The Glucose Cup Module stirrer bar is turned on during the reagent fill | Stirrer bar off during reagent fill | | User Interface | DxC Console (User Interface) operating system QNX 6.4 | DxC Console (User Interface) operating system from QNX 6.3 | {3} 4 of 8 K. Standard/Guidance Document Referenced (if applicable): CLSI - Evaluation of Precision Performance of Clinical Chemistry Devices - EP05-A2 CLSI - Evaluation of the Linearity of Quantitative Analytical Methods - EP06-A CLSI - Method Comparison and Bias Estimation Using Patient Samples - EP09-A2 L. Test Principle: Glucose concentration is measured by an oxygen rate method employing a Beckman Coulter Oxygen electrode. A sample is injected in a reaction cup containing a glucose oxidase solution. The ratio used is one part sample to 76 parts reagent. The peak rate of oxygen consumption is directly proportional to the concentration of glucose in the sample. Oxygen is consumed at the same rate as glucose reacts to form gluconic acid. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run and total imprecision studies were designed from CLSI Guideline EP5-A2, "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition." The experimental design utilized duplicate sample analysis, twice daily, over the course of twenty working days. The objective of this testing was to verify the DxC v5.0 software changes at system level has not induced inadvertent harm to the functioning of the DxC system. This was assessed via an EP5 Random Access Precision performance evaluation with a representative chemistry, Glucose running on DxC 800 System with the v5.0 software. Results of the within run and total precision evaluation for the SYNCHRON System Glucose (GLUCm) Reagent. | Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N | | --- | --- | --- | --- | --- | | Within-Run Imprecision | | | | | | Serum/Plasma Level 1 | 41.7 | 0.8 | 2.0 | 80 | | Serum/Plasma Level 2 | 376.9 | 1.1 | 0.3 | 80 | | Urine Level 1 | 28.6 | 0.8 | 2.9 | 80 | | Urine Level 2 | 290.9 | 1.0 | 0.3 | 80 | | CSF Level 1 | 58.0 | 1.2 | 2.0 | 80 | | CSF Level 2 | 27.6 | 0.9 | 3.1 | 80 | {4} 5 of 8 | Total Imprecision | | | | | | --- | --- | --- | --- | --- | | Serum/Plasma Level 1 | 41.7 | 0.8 | 2.0 | 80 | | Serum/Plasma Level 2 | 376.9 | 2.0 | 0.5 | 80 | | Urine Level 1 | 28.6 | 1.1 | 3.7 | 80 | | Urine Level 2 | 290.9 | 1.7 | 0.6 | 80 | | CSF Level 1 | 58.0 | 1.2 | 2.1 | 80 | | CSF Level 2 | 27.6 | 1.1 | 4.0 | 80 | b. Linearity/assay reportable range: Linearity (analytical range) studies were designed in accordance with CLSI Guideline EP6-A. “Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach.” The objective of this testing was to verify the DxC v5.0 software changes at system level has not induced inadvertent harm to the functioning of the DxC system. This was assessed via a linearity verification using a representative chemistry, Glucose running on DxC 800 System with the v5.0 software. Results of linearity for the SYNCHRON System Glucose (GLUCm) Reagent: | Analyte | Sample Type | Measuring Range | Linear Regression Analysis | | --- | --- | --- | --- | | GLUCm | Serum/ Plasma | 3 – 600 mg/dL | Y = 1.005X + 1.7305 R_{2} = 1.0000 | c. Traceability, Stability, Expected values (controls, calibrators, or methods): Refer to k060256 d. Detection limit: Refer to k060256 e. Analytical specificity: Refer to k060256 f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: Method comparison experiments were designed using CLSI Procedure EP9-A2: “Method Comparison and Bias Estimation Using Patients Samples” and employed Deming regression analysis to assess the data. The objective of this testing was to verify the DxC 800 System v5.0 software changes at system level has not induced inadvertent harm to the functioning of the DxC system. This was assessed via a serum method comparison study on DxC systems with the v5.0 software and comparing sample recoveries to DxC {5} 800 System with the v4.9 software. Results of the method comparison study for the SYNCHRON System Glucose (GLUCm) Reagent: | Candidate | Analyte | Slope | Intercept | R | N | Predicate Method | | --- | --- | --- | --- | --- | --- | --- | | UniCel DxC System with v5.0 Software | GLUCm | 0.987 | 0.629 | 1.000 | 120 | UniCel DxC System with v4.9 Software |  b. Matrix comparison: Refer to k060256 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: {6} In the labeling the sponsor states that each laboratory should establish its own reference intervals based upon its patient population. The reference intervals listed below were taken from literature and a study performed on SYNCHRON Systems* | INTERVALS | SAMPLE TYPE | CONVENTIONAL UNITS | S.I. UNITS | | --- | --- | --- | --- | | Literature | Serum or Plasma | 74 – 106 mg/dL | 4.1 – 5.9 mmol/L | | | Urine* | 1 – 15 mg/dL | 0.06 – 0.83 mmol/L | | | Urine (timed)* | < 0.5 g/24 hrs | < 2.8 mmol/24 hrs | | | CSF | 40 – 70 mg/dL | 2.2 – 3.9 mmol/L | | SYNCHRON | Serum or Plasma | 74 – 118 mg/dL | 4.1 – 6.6 mmol/L | a In a healthy patient, the normal urine glucose value is zero. * Tietz, N. W., Clinical Guide to Laboratory Tests, 3rd Edition, W. B. Saunders, Philadelphia, PA (1995). N. Instrument Name: UniCel DxC 800 SYNCHRON System O. System Descriptions: 1. Modes of Operation: Random access Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?: Yes ☐ X or No ☐ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?: Yes ☐ or No ☐ X 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 coded {7} 4. Specimen Sampling and Handling: Standard components (probes, mixers, wash cups, racks, shuttle, bar code readers) plus Cap Piercing and Obstruction Detection assemblies. 5. Calibration: Calibration chemistries include endpoint, first order rate, nonlinear, and qualitative cutoff reactions. Zero-order rate chemistries include enzymes which use extinction coefficients (of coenzymes or chromophore, of either substrate or end product), and require no routine calibration. 6. Quality Control: Has a built in quality control program P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: Not Applicable Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 8 of 8