The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, and ion selective electrode.

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

The sodium test system is intended for the quantitative measurement sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The potassium test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Description

The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination and ion selective electrode. Electrolyte measurement is performed using a single cell Ion Selective Electrode (ISE) which is also common among the other members of the AU family.

The ISE module for Na*, K*, and Cl employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the Internal Reference Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.

In this Beckman Coulter procedure, glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH).

The CRP Latex reagent is an in vitro diagnostic device that consists of ready to use buffer and latex particles coated with rabbit anti-CRP antibodies. Depending on the application used (different instrument settings), two measuring ranges are available: Normal application (CRP Concentrations ranging between 1.0-480 mg/L) and Highly Sensitive (Cardiac/ Neonatal) Application- (CRP concentrations ranging between 0.2- 80mg/L).

AI/ML Overview

This document is a 510(k) Pre-Market Notification from Beckman Coulter for their DxC 700 AU Clinical Chemistry Analyzer and associated reagents (ISE Reagents, Glucose, and CRP Latex). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo. Therefore, the "acceptance criteria" and "proof" are focused on demonstrating substantial equivalence through comparative performance testing against a predicate device, rather than setting absolute performance thresholds for a novel device.

The study proves the device meets the acceptance criteria by showing its performance is comparable to the predicate device (AU5800 Clinical Chemistry Analyzer) across various analytical parameters.

Here's a breakdown of the information as requested, largely based on the provided text, while noting the differences that arise from a 510(k) submission's nature:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are not absolute performance metrics but rather a demonstration that the new device performs similarly to or better than the predicate device. The goal is to show substantial equivalence. The tables below summarize the key performance parameters tested for the DxC 700 AU and its reagents against predicate devices/established guidelines. No explicit "acceptance criteria" values are stated in terms of thresholds, but meeting the "required specifications" (which would be internal to the manufacturer, often based on CLSI guidelines or clinical relevance) is implied by the "Pass" results.

Study Type	Measured Parameter / Comparison	Performance Result (DxC 700 AU)
Method Comparison	Linearity, comparison to predicate AU5800	Sodium, Serum: Slope: 1.007, Intercept: -0.779, r: 0.999 Sodium, Urine: Slope: 1.014, Intercept: -1.392, r: 1.000 Potassium, Serum: Slope: 0.988, Intercept: 0.048, r: 0.999 Potassium, Urine: Slope: 1.011, Intercept: -0.149, r: 1.000 Chloride, Serum: Slope: 0.999, Intercept: 0.224, r: 0.999 Chloride, Urine: Slope: 1.036, Intercept: -3.679, r: 1.000 Glucose Serum: Slope: 1.014, Intercept: 0.040, r: 1.000 CRP Latex (HS) Serum: Slope: 1.013, Intercept: -0.050, r: 1.000 All "met the required specifications"
Matrix Comparison	Glucose (EDTA, NaF-KOx, Li Heparin, NaF-EDTA vs Serum)	EDTA: Slope: 0.999, Intercept: -0.099, R: 0.998, Bias: -0.199 (Pass) NaF-KOx: Slope: 1.007, Intercept: 0.127, R: 0.998, Bias: 0.827 (Pass) Li Heparin: Slope: 0.996, Intercept: -0.076, R: 0.998, Bias: -0.476 (Pass) NaF-EDTA: Slope: 1.005, Intercept: 0.133, R: 0.998, Bias: 0.633 (Pass) Glucose Specification: Slope: 0.95-1.05; Intercept: ±3.8 mg/dL; R: ≥0.95; Bias: ±3% at 100 mg/dL
	CRP Latex (HS) (EDTA, Li Heparin vs Serum)	EDTA: Slope: 0.990, Intercept: -0.059, R: 0.9992, Bias: -2.97 (Pass) Li Heparin: Slope: 0.985, Intercept: -0.013, R: 0.9995, Bias: -1.93 (Pass) CRP Specification: Slope: 0.9-1.1; Intercept: ±0.2 mg/L; R: ≥0.95; Bias: ±6% at 3mg/L
Linearity/Reportable Range	Demonstrates linearity through claimed dynamic range	Sodium, Serum: Linear From 6.69 to 245.97 mEq/L Sodium, Urine: Linear From 9.04 to 417.43 mEq/L Potassium, Serum: Linear From 0.14 to 12.44 mEq/L Potassium, Urine: Linear From 1.02 to 223.47 mEq/L Chloride, Serum: Linear From 5.92 to 246.78 mEq/L Chloride, Urine: Linear From 14.10 to 421.31 mEq/L Glucose Serum: Linear From 5.20 to 843.18 mg/dL CRP Latex (HS) Serum: Linear From 0.15 to 92.49 mg/L Performance data "demonstrates linearity throughout the claimed dynamic range of each assay."
Sensitivity (Detection Limits)	LoB, LoD, LoQ comparison to claimed measuring range	Glucose, Serum: LoB: 0, LoD: 0.42, LoQ: 2.68 (claimed range: 10 mg/dL) CRP Latex (HS), Serum: LoB: 0.04, LoD: 0.08, LoQ: 0.08 (claimed range: 0.2 mg/L) All "met specifications and were below the claimed measuring range of the reagent."
Precision/Reproducibility	Within-run (Repeatability) & Within Laboratory (Total) Precision	Data provided for CRP Latex (HS), Glucose, Sodium, Potassium, Chloride (Serum & Urine) showing %CV and SD across multiple levels. All "met the performance precision specifications." (See Table 9.5.1 in original document for full data)
In-Use & Cal. Stability	Reagent and ISE Stability Verification	CRP Latex (HS): Onboard Stability Claim 90 days, Calibration Stability Claim 90 days Glucose: Onboard Stability Claim 30 days, Calibration Stability Claim 30 days ISEs (Na, K, Cl): Calibration Stability Claim 1 day (Serum & Urine) All results "were within specification and provide data to support the onboard and calibrations stability claims."
Interferences	LIH (Lipemia, Icterus, Hemolysis) Tolerance	Chloride: Bilirubin (unconjugated) 40 mg/dL (NSI), Hemoglobin 500 mg/dL (NSI), Lipemia 500 mg/dL (NSI) Potassium: Bilirubin (unconjugated) 40 mg/dL (NSI), Hemoglobin 70 mg/dL (NSI), Lipemia 500 mg/dL (NSI) Sodium: Bilirubin (unconjugated) 40 mg/dL (NSI), Hemoglobin 250 mg/dL (NSI), Lipemia 500 mg/dL (NSI) Glucose: Lipemic (Intralipid) 700 mg/dL (<10% intf.), Icteric (Unconjugated) 40 mg/dL (<10% intf.), Hemolytic 500 mg/dL (<10% intf.) CRP Latex (HS): Intralipid (1000 mg/dL) (<10% intf. at 1mg/L), Bilirubin (40 mg/dL) (<5% intf. at 1mg/L), Hemolysate (500 mg/dL) (<5% intf. at 1mg/L) All "met the required specifications." NSI = No Significant Interference within specified variance limits.
Prozone	CRP Latex (HS) Prozone Performance	Samples with CRP concentrations up to 750 mg/L will not generate falsely low results within the analytical range.

2. Sample Size Used for the Test Set and Data Provenance

The document describes the sample sizes specifically for the performance validation studies:

Method Comparison and Bias Estimation: A minimum of 100 serum, urine, and CSF samples were tested over five days. "No more than 20% of samples were either spiked or diluted."
Matrix Comparison (Anticoagulation Studies): For Glucose and CRP Latex (HS), 50 samples were tested for each anticoagulant type.
Linearity/Assay Reportable Range: High and low pools were prepared and inter-diluted. Each dilution was assayed in quadruplicate.
Sensitivity (Detection Limits): Total of 60 blank replicates per reagent lot (4 blank samples run 5-fold for 3 days) and 280 low level sample replicates per reagent lot (7 low level samples run 5-fold for 8 days) were generated. This was across 2 lots of reagent.
Precision/Reproducibility: n=80 for each sample level (duplicate sample analysis, twice daily, over the course of 20 days). This implies a high number of individual measurements.
In-Use and Calibration Stability Verification: Tested using one reagent lot (where appropriate) and one calibrator lot. Controls run in duplicate at each time point.
Interferences: All test samples assayed in quadruplicate at two analyte levels.
Prozone: Human serum was spiked to create a prozone pool. Eleven dilutions of the high prozone pool were then prepared and run n=3.

Data Provenance:
The document does not explicitly state the country of origin for the patient samples. The studies appear to be prospective as they involved specific experimental designs, preparation of samples (e.g., spiking, dilution), and controlled testing on the new DxC 700 AU analyzer and comparison to the predicate AU5800. The studies were conducted in a controlled laboratory setting by Beckman Coulter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes the analytical validation of an in vitro diagnostic (IVD) device, specifically a clinical chemistry analyzer and its reagents. For such devices, "ground truth" is typically established by:

Reference Methods/Predicate Devices: The DxC 700 AU's performance is compared against its predicate device, the AU5800, which serves as the established "truth" or reference within the context of substantial equivalence.
Clinically Accepted Norms/Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP09-A3, EP06-A, EP17-A2, EP05-A3, EP25-A, EP07-A2). These guidelines represent consensus standards in laboratory medicine.

Therefore, this does not involve human experts (like radiologists reading images) establishing ground truth on a per-case basis. The "experts" are the scientific and medical community that developed and validated the methodologies in the CLSI guidelines, and the manufacturers who established the predicate device's performance.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1 consensus) are typically used in image-based diagnostic studies where human readers provide interpretations that need to be reconciled to establish a ground truth for a test set. This document is for a clinical chemistry analyzer and reagents. The "ground truth" (or reference values) for the measured analytes (Sodium, Potassium, Chloride, Glucose, CRP) are derived from the predicate device or established laboratory methods, and direct comparison of quantitative measurements. There is no human interpretation or adjudication of individual results described in the process of establishing ground truth for this type of IVD.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where the AI assists human readers. For a clinical chemistry analyzer, the evaluation focuses on the analytical performance of the device itself (accuracy, precision, linearity, etc.) in quantifying specific analytes, and demonstrating equivalence to a predicate device. It's a direct measurement system, not an interpretive aid for human "readers".

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense, the entire analytical validation is a "standalone" performance evaluation of the DxC 700 AU Clinical Chemistry Analyzer and its reagents. The device operates automatically to measure analytes. The performance metrics (accuracy, precision, linearity, detection limits, interference) are all measures of the analyzer's inherent capability to produce a quantitative result, without human qualitative interpretation being part of the measurement process itself. The "human-in-the-loop" refers to the operator physically loading samples and calibrating the machine, but not to the diagnostic interpretation of each individual result by a human.

7. The Type of Ground Truth Used

The "ground truth" for the performance validation in this 510(k) submission is derived from:

Measurement against a Predicate Device: The majority of the studies (e.g., Method Comparison) demonstrate that the DxC 700 AU produces results that are substantially equivalent to those obtained from the already legally marketed AU5800 Clinical Chemistry Analyzer. This served as the primary reference for comparison.
Established Analytical Methods: For parameters like linearity, sensitivity, precision, and interference, the ground truth is against predefined analytical and statistical specifications and expected performance characteristics for such IVD assays, often guided by CLSI standards.
Reference Materials: For linearity, "high and low pools" were prepared, which would have analytically defined concentrations. For sensitivity, "blank and low level samples" were used.

It is not based on expert consensus (like multiple clinical reads) or pathology/outcomes data in the way it would be for a diagnostic imaging device.

8. The Sample Size for the Training Set

This document describes the validation of a laboratory instrument and reagents, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this 510(k) submission. The data presented are for Analytical Performance testing to demonstrate substantial equivalence to an existing predicate device.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for a machine learning model, this question is not applicable to the provided document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2016

BECKMAN COULTER INC. GERALDINE FUENTESPINA MANAGER, REGULATORY AFFAIRS 250 S. KRAEMER BLVD. MAILS STOP E1.SE.01 BREA, CA 92821

Re: K161837

Trade/Device Name: ISE Reagents, Glucose, and CRP Latex on the DxC 700 AU Clinical Analyzer Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: II Product Code: JGS, CEM, CGZ, CFR, NQD, JJE Dated: December 2, 2016 Received: December 5, 2016

Dear Geraldine Fuentespina:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161837

Device Name

DxC 700 AU Clinical Chemistry Analyzer, CRP Latex, Glucose, ISE Reagents

Indications for Use (Describe)

Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1.0 Submitted By

Geraldine Fuentespina Manager, Requlatory Affairs Beckman Coulter, Inc. 250 S. Kraemer Blvd. Mail Stop: E1.SE.01 Brea, CA 92821 Telephone: (714) 961-3777 Fax: (714) 961-4234

2.0 Date of Preparation

14 December 2016

3.0 Device Name(s)

3.1 ISE Reagent

Proprietary Name:	ISE Reagents
Common Name:	ISE Reagents
Class:	2
Classification Name/Regulation Number/Product Code:	Sodium test system 21 CFR § 862.1665 [JGS]
	Potassium test system 21 CFR § 862.1600 [CEM]
	Chloride test system 21 CFR § 862.1170 [CGZ]

3.2 Glucose

Proprietary Name:	Glucose
Common Name:	Glucose
Class:	2
Classification Name:	Glucose test system
Regulation Number:	21 CFR § 862.1345
Product Code:	CFR

3.3 CRP Latex

Proprietary Name:	CRP Latex
Common Name:	CRP Latex
Class:	2
Classification Name:	C-reactive protein immunological test system
Regulation Number:	21 CFR § 866.5270
Product Code:	NQD

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3.4 DxC 700 AU Clinical Chemistry Analyzer

Proprietary Name:	DxC 700 AU Clinical Chemistry Analyzer
Common Name:	DxC 700 AU
Class:	1
Classification Name:	Discrete photometric chemistry analyzer for clinical use
Regulation Number:	21 CFR § 862.2160
Product Code:	JJE

4.0 Predicate Devices

Candidate(s)	Predicate	Manufacturer
ISE Reagents : Sodium andChloride	ISE Reagents : Potassium,Sodium and Chloride(K003721)	Beckman Coulter,Inc.
ISE Reagents : Potassium	ISE Reagents : Potassium(K112412)	Beckman Coulter,Inc.
Glucose	Glucose(K112412)	Beckman Coulter,Inc.
CRP Latex	OLYMPUS CRP LatexImmunoturbidimetric Reagent(K051564)	Beckman Coulter,Inc.
DxC 700 AU ClinicalChemistry Analyzer	AU5800 Clinical ChemistryAnalyzer(K112412)	Beckman Coulter,Inc.

5.0 Device Description

5.1 ISE Reagents

Reactive Ingredients: ISE Buffer (Triethanolamine), Mid-Standard (Na, K, CI), Reference (Potassium Chloride), High Serum Standard (Na, K, CI), Low Serum Standard (Na, K, CI), High/Low Urine Standard (Na, K, CI), Internal Reference Solution (Potassium Chloride, Silver Chloride), and Na*/K* Selectivity Check Solution (Na, K).

5.2 Glucose

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For the AU400/AU640/AU600 the change in absorbance at 340/380 nm is proportional to the amount of glucose present in the sample. For the AU5800/AU5400/AU2700/AU680/AU480/DxC 700 AU the change in absorbance at 340/660 nm is proportional to the amount of glucose present in the sample.

Reactive Ingredients: PIPES- buffer (pH 7.6), NAD*, Hexokinase, ATP, Mg4*, G6P-DH

5.3 CRP Latex

Reactive Ingredients: Glycine buffer, Latex coated with anti-CRP Antibodies.

5.4 DxC 700 AU Clinical Chemistry Analyzer

The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination and ion selective electrode. Electrolyte measurement is performed using a single cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

6.0 Indications for Use

6.1 ISE Reagents (Sodium, Potassium and Chloride)

Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

The potassium test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device

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are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The chloride test system is intended for the quantitative measurement the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

6.2 Glucose

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

6.3 CRP Latex

6.4 DxC 700 AU Clinical Chemistry Analyzer

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7.0 Comparison to the Predicate

The DxC 700 AU Clinical Chemistry System is a family member of the AU series of analyzers, including the AU5800 (K112412) to which the substantial equivalence comparison is claimed. The devices have same / similar design and modes of operation. The key features are summarized in the following tables:

Feature	Predicate Device:ISE Reagents – Sodium andChloride(K003721)	Proposed Device:ISE Reagents - Sodium andChloride
Item Number	AUH1011, AUH1012, AUH1013,AUH1014, AUH1015, AUH1016,AUH1017, AUH1018	Same
Intended Use	Reagent for the quantitativedetermination of Sodium,Potassium and Chlorideconcentrations in human serumand urine on the BeckmanCoulter ISE modules.	Same
Measurement	Quantitative	Same
InstrumentRequired	AU400/400°, AU600/640/640°,AU800,AU1000, AU5200 andAU2700 Beckman CoulterAnalyzers	AU400/400°/480,AU600/640/640°/680,AU2700/5400/AU5800 and DxC700 AU Beckman CoulterAnalyzers.
Methodology	Indirect ISE	Same
Reagent form andstorage	Liquid, on-board storage	Same
Specimen Type	Serum, plasma and urine	Same
Calibrator	AUH1014 Low Serum StandardAUH1015 High Serum StandardAUH1016 High/Low UrineStandard	Same
Calibration Stability	Calibrate daily.	Same
Reagent stability	AUH1011, AUH1012, andAUH1013 are stable for 90 dayswhen opened and stored in theISE reagent compartment of theanalyzer.After opening AUH1014,AUH1015, AUH1016, andAUH1018 may be stored at 2 -25°C for up to 90 days, providedthe cap is replaced immediatelyafter each use. After opening,AUH1017 may be stored at 15 -25°C for up to 90 days.	Same
Feature	Predicate Device:ISE Reagents - Sodium andChloride(K003721)	Proposed Device:ISE Reagents - Sodium andChloride
Analytic Range	Serum$Na^+ 50 - 200$ mEq/L$Cl^- 50 - 200$ mEq/LUrine$Na^+ 10 - 400$ mEq/L$Cl^- 15 - 400$ mEq/L	Same

7.1 ISE Reagents (Sodium & Chloride) Predicate Device Comparison Table

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7.2 ISE Reagents (Potassium) Predicate Device Comparison Table

Feature	Predicate Device:ISE Reagents - Potassium(K112412)	Proposed Device:ISE Reagents – Potassium
Item Number	AUH1011, AUH1012, AUH1013,AUH1014, AUH1015, AUH1016,AUH1017, AUH1018	Same
Intended Use	Reagent for the quantitativedetermination of Sodium,Potassium and Chlorideconcentrations in human serumand urine on the BeckmanCoulter ISE modules.	Same
Measurement	Quantitative	Same
InstrumentRequired	AU400/400e/480,AU600/640/640o/680 andAU2700/5400/AU5800 BeckmanCoulter Analyzers	AU400/400e/480,AU600/640/640o/680,AU2700/5400/AU5800 and DxC700 AU Beckman CoulterAnalyzers.
Methodology	Indirect ISE	Same
Reagent form andstorage	Liquid, on-board storage	Same
Specimen Type	Serum, plasma and urine	Same
Calibrator	AUH1014 Low Serum StandardAUH1015 High Serum StandardAUH1016 High/Low UrineStandard	Same
Calibration Stability	Calibrate daily.	Same
Reagent stability	AUH1011, AUH1012, andAUH1013 are stable for 90 dayswhen opened and stored in theISE reagent compartment of theanalyzer.After opening AUH1014,AUH1015, AUH1016, andAUH1018 may be stored at 2 –25°C for up to 90 days, providedthe cap is replaced immediatelyafter each use. After opening,AUH1017 may be stored at 15 –25°C for up to 90 days.	Same

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Feature	Predicate Device:ISE Reagents - Potassium(K112412)	Proposed Device:ISE Reagents - Potassium
Analytic Range	Serum$K^+ 1.0 - 10.0$ mEq/LUrine$K^+ 2.0 - 200.0$ mEq/L	Same

7.3 Glucose Predicate Device Comparison Table

Feature	Predicate Device:Glucose(K112412)	Proposed Device:Glucose
Item Number	Glucose (OSR6121, OSR6221,OSR6621)	Same
Intended Use	System reagent for thequantitative determination ofGlucose in human serum,plasma, urine and cerebrospinalfluid on Beckman Coulter AUanalyzers.	Same
Measurement	Quantitative	Same
InstrumentRequired	AU400/400 e/480,AU600/640/6406/680 andAU2700/5400/AU5800 BeckmanCoulter Analyzers	AU400/400 e/480,AU600/640/6406/680,AU2700/5400/AU5800 and DxC700 AU Beckman CoulterAnalyzers.
Methodology	Photometric	Same
Reagent form andstorage	Liquid, on-board storage	Same
Specimen Type	Serum, plasma, urine andcerebrospinal fluid	Same
Calibrator	Chemistry Calibrator (Cat #DR0070)Urine Calibrator (Cat # DR0090)	Same
CalibrationStability	30 days	Same
Onboard Stability	30 days refrigerated	Same
Analytic Range	Serum, plasma and CSF:10 - 800 mg/dLUrine:10 - 700 mg/dL	Same

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Feature	Predicate Device:CRP Latex	Proposed Device:
	(K051564)	CRP Latex
Item Number	CRP Latex (OSR6199)	Same
Intended Use	Olympus System Reagent andcalibrators for the quantitativedetermination of C-ReactiveProtein in human serum andplasma on OLYMPUSAnalyzers. Measurement ofCRP is useful for the detectionand evaluation of infection,tissue injury, inflammatorydisorders and associateddiseases. Measurements mayalso be used as an aid in theidentification of individuals atrisk of future cardiovasculardisease. High sensitivity CRP(hsCRP) measurements, whenused in conjunction withtraditional clinical laboratoryevaluation of acute coronarysyndromes, maybe useful asan independent marker ofprognosis for recurrent events,in patients with stable coronarydisease or acute coronarysyndromes.	SameSystem reagent for thequantitative determination ofC-Reactive Protein in humanserum and plasma onBeckman Coulter AUAnalyzers. Measurement ofCRP is useful for the detectionand evaluation of infection,tissue injury, inflammatorydisorders and associateddiseases. Measurements mayalso be useful as an aid in theidentification of individuals atrisk for future cardiovasculardisease. High sensitivity CRP(hsCRP) measurements, whenused in conjunction withtraditional clinical laboratoryevaluation of acute coronarysyndromes, may be useful asan independent marker ofprognosis for recurrent events,in patients with stable coronarydisease or acute coronarysyndromes.
Measurement	Quantitative	Same
Instrument Required	AU400/400°/480,AU600/640/640°/680 andAU2700/5400/AU5800Beckman Coulter Analyzers	AU400/400°/480,AU600/640/640°/680,AU2700/5400/AU5800 andDxC 700 AU Beckman CoulterAnalyzers.
Methodology	Latex enhancedImmunoturbidimetric	Same
Antibody	Rabbit Anti-CRP Antibodies	Same
Reagent form andstorage	Liquid, on-board storage	Same
Specimen Type	Serum and plasma	Same
Calibrator	CRP Latex Highly SensitiveCalibrator (Cat # ODC0027)for the Highly Sensitive(Cardiac / Neonatal)Application.	Same
Calibration Stability	30 days refrigerated	90 days refrigerated
Onboard Stability	30 days refrigerated	90 days refrigerated
Analytic Highly Sensitive Range	0.2 - 160 mg/L	0.2 to 80 mg/L

CRP Predicate Device Comparison Table 7.4

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7.5 AU5800 versus the DxC 700 AU Predicate Device Comparison Table
Feature	Predicate Device:AU5800 Clinical ChemistryAnalyzer(K112412)	Proposed Device:DXC 700 AU ClinicalChemistry Analyzer
Intended Use:	The Beckman Coulter AU5800Clinical Chemistry Analyzer is anautomated chemistry analyzerthat measures analytes insamples, in combination withappropriate reagents,calibrators, quality control (QC)material and other accessories.This system is for in vitrodiagnostic use only.Applications include colorimetric,turbidimetric, latex agglutination,homogeneous enzymeimmunoassay, and ion selectiveelectrode.	Similar to predicate.The Beckman Coulter DxC 700AU Clinical Chemistry Analyzeris an automated chemistryanalyzer that measures analytesin samples, in combination withappropriate reagents,calibrators, quality control (QC)material and other accessories.This system is for in vitrodiagnostic use only.Applications include colorimetric,latex agglutination and ionselective electrode.
Classification:	Analyzer, chemistry(photometric, discrete), forclinical use has been classifiedas Class I, JJE by the ClinicalChemistry and ClinicalToxicology Devices Panel, (21CFR 862.2160).	Identical to predicate.
Sample Handling
Sample Containers	10 sample tubes on a Rack	Identical to predicate.
Sample Volume	1.0 to 17.0 µL	1.0 to 25.0 µL
Sample Types	Serum, urine, CSF and Plasma	Identical to predicate.
Sample Input	Sample Racks	Sample Rack, STAT Table,Direct-line Sample Aspiration(For Automation Connections)
Single SampleReplicate Analysis	None.	Ability to request test replicatesfor one sample, up to 20replicates per sample per test.
Sample Analysis
Wavelength (nm)	Halogen Lamp340 to 800 nm13 wavelengths:340, 380, 410, 450, 480, 520,540, 570, 600, 660, 700, 750and 800 nm (maximum of 2wavelengths)	Identical to predicate.
Type ofMeasurement	• End point assay• Rate assay• Fixed point assay• Electrode method (ISE)	Identical to predicate.
Throughput	Maximum 2000 photometrictests/hour/unit	Maximum 800 photometrictests/hour or 1200 tests/hour(photometric + ISE)
Feature	Predicate Device:AU5800 Clinical ChemistryAnalyzer(K112412)	Proposed Device:DxC 700 AU ClinicalChemistry Analyzer
Reagent Handling
ReagentIdentification	Barcode and fixed position in thereagent carousel	Identical to predicate
Refrigerated	System has 2 ReagentRefrigerators	System has 2 ReagentRefrigerators:
Reagent On-boardCapacity	Reagent 1: 54 bottle capacityReagent 2: 54 bottle capacity	Reagent 1: 60 bottle capacityReagent 2: 48 bottle capacity
ISE Reagents	3 ISEs	Identical to predicate.
Reagent StorageTemperature	Refrigeration temperature: 4 to12 °C (39.2 to 53.6 °F)	Identical to predicate
Reagent Loadingduring Analysis	Not available.	Reagent bottles can be changedon the DxC 700 AU while theinstrument continues to measurepatient samples.
	Prior to replacing reagentbottles, the AU5800 existinganalysis must be completed andsystem must be in Pause Mode.This may take up to 24 minutesafter customer requests reagentreplacement.	On the DxC 700 AU, a reagentbottle can be added or changedwithin 5 minutes of request.
Computers/OS
CPU	Single Intel ProcessorrunningWindows XP Pro 32bit	Intel ProcessorrunningWindows 7 64bit
Display/Monitor	19" displaywith touch screen	24" displaywith touch screen
Handheld BarcodeReader	Not Available	Provided for reading 1D and 2Dbarcodes
Software
GUI Application	User interface unique to AUChemistry systems	User interface which will becommon to new BeckmanCoulter IVD systems
Result DatabaseCapacity	300 (Index)9999 (Sample / Index)400000 (test)	Identical to predicate.
User Help	PDF of IFU is available	HTML version of IFU isaccessible with built-ininteractive video.
LaboratoryInformation System(LIS) Interfaces	Similar with LIS ASTM 1394 andAU unique LIS protocol	Identical to predicate.
LaboratoryAutomation System(LAS) Interfaces	Beckman LAS interface for RackBuilder	Beckman LAS interface forDirect Track Sampling system
Feature	Predicate Device:AU5800 Clinical ChemistryAnalyzer(K112412)	Proposed Device:DxC 700 AU ClinicalChemistry Analyzer
Real-TimeSolutions(RTS) support	Interface to RTS viaPRO Service protocol which ismade by Beckman Coulter	Interface to RTS viaPRO Service protocol which ismade by Beckman CoulterRemote software installationcapabilities.
External printers	Parallel port and USBinterfaced printers	USB and LANinterfaced printers

AU5800 versus the DxC 700 AU Predicate Device Comparison Table 7 5

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8.0 Comparison testing

In order to further demonstrate the comparability of the predicate device, AU5800 and the candidate device, DxC 700 AU, the following reagent performance testing was performed on a representative number of assays:

Method Comparison Matrix Comparison Linearity Sensitivity Precision Interference In use (On board) & Calibrator Stability Prozone Sample Dilution
The DxC 700 AU chemistry analyzer uses the same lon Selective Electrode (ISE) and reagents, as well as the same menu of reagents currently available on the AU5800. Representative assays from the AU chemistry menu were selected to demonstrate equivalency between the predicate device, AU5800, and the candidate device, DxC 700 AU.

The CRP Latex reagent can be used to measure CRP on the DxC 700 AU chemistry analyzer using two applications, a normal application and a high sensitivity (cardiac) application. Only the CRP high sensitivity (cardiac) application was reviewed in this submission as a representative assay.

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Summary of Performance Data 9.0

This 510(k) submission provides the data necessary to demonstrate equivalence of the predicate device to the candidate device based on the performance validations and comparisons conducted between the representative reagents and analyzer platforms. Based on this data. the new DxC 700 AU Chemistry Analyzer is substantially equivalent to the referenced predicate.

9.1 Method Comparison with Predicate Device:

Method comparison and bias estimation experiments were designed using CLSI Guideline EP09-A3 "Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline". These patient correlation studies demonstrate equivalence between the predicate AU5800 and the candidate DxC 700 AU. A minimum of 100 serum, urine and CSF samples were tested over five days. No more than 20% of samples were either spiked or diluted to ensure a uniform distribution over the analytical range. Each spiked or diluted sample was made from an individual sample. All method comparisons met the required specifications as detailed in the tables below.

Analyte	# of samples	Units	Slope	Intercept	r
Sodium, Serum	120	mEq/L	1.007	-0.779	0.999
Sodium, Urine	130	mEq/L	1.014	-1.392	1.000
Potassium, Serum	122	mEq/L	0.988	0.048	0.999
Potassium, Urine	127	mEq/L	1.011	-0.149	1.000
Chloride, Serum	118	mEq/L	0.999	0.224	0.999
Chloride, Urine	129	mEq/L	1.036	-3.679	1.000
Glucose Serum	130	mg/dL	1.014	0.040	1.000
CRP Latex (HS) Serum	117	mg/L	1.013	-0.050	1.000

Table 9.1.1 Reagent Method Comparison Data

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9.2 Matrix Comparison Study

Anticoagulation Studies were designed using CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Third Edition.

9.2.1 Glucose

The serum recovery from the Glucose test was compared to the corresponding EDTA, Sodium Fluoride Potassium Oxalate, Sodium Fluoride EDTA and Lithium Heparin for the same donor.

Anticoagulant	No. ofSamplestested	Sample Range(mg/dL)	Regressionanalysis	Specification	Result
EDTA	50	19.72 - 752.31	Slope: 0.999Intercept: -0.099R: 0.998Bias: -0.199		Pass
SodiumFluoridePotassiumOxalate	50	19.72 - 752.31	Slope: 1.007Intercept: 0.127R: 0.998Bias: 0.827	Slope: 0.95-1.05Intercept: ± 3.8mg/dLR: ≥ 0.95Bias: ± 3% at 100 mg/dL	Pass
Lithium Heparin	50	19.72 - 752.31	Slope: 0.996Intercept:-0.076R: 0.998Bias: -0.476		Pass
SodiumFluoride EDTA	50	19.72 - 752.31	Slope: 1.005Intercept: 0.133R: 0.998Bias: 0.633		Pass

Table 9.2.1 Anticoagulant study results for Glucose reagent (OSR6x21)

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9.2.2 CRP Latex

The serum recovery from the CRP Latex test (highly sensitive application) was compared to the corresponding EDTA and Lithium Heparin for the same donor.

Table 9.2.2 Anticoagulant study results for CRP Latex reagent (OSR6x99)
--------------------------------------------------------------------------	--	--	--

Anticoagulant	No. ofSamplestested	Sample Range(mg/dL)	Regressionanalysis	Specification	Result
EDTA	52	0.34 - 73.11	Slope: 0.990Intercept: -0.059R: 0.9992Bias: -2.97	Slope: 0.9-1.1Intercept: ± 0.2 mg/LR: ≥ 0.95Bias: ± 6% at 3mg/L	Pass
Lithium Heparin	52	0.34 - 73.11	Slope: 0.985Intercept: -0.013R: 0.9995Bias: -1.93		Pass

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Image /page/18/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, resembling a stylized wave or ribbon. To the right of the oval, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font. The overall design is clean and modern, conveying a sense of innovation and technology.

9.3 Linearity/Assay Reportable Range:

Analytical range (linearity) studies were designed to meet the requirements of CLSI quidelines EP06-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline".

High and low pools were prepared and inter-diluted to achieve concentrations spanning the required linear range. Each dilution was assayed in quadruplicate on the DxC 700 AU. The performance data for the study demonstrates linearity throughout the claimed dynamic range of each assay, as represented in the tables below.

					Results
Analyte	Units	Slope	Intercept	r	LinearFrom	Linearto
Sodium,Serum	mEq/L	1.0165	-1.6158	0.9999	6.69	245.97
Sodium,Urine	mEq/L	1.0506	-2.7363	0.9994	9.04	417.43
Potassium,Serum	mEq/L	1.0207	-0.1224	0.9996	0.14	12.44
Potassium,Urine	mEq/L	0.9883	0.0571	0.9999	1.02	223.47
Chloride,Serum	mEq/L	1.0362	-3.6836	0.9995	5.92	246.78
Chloride,Urine	mEq/L	1.0476	-3.5026	0.9994	14.10	421.31
GlucoseSerum	mg/dL	0.9834	-0.0628	0.9999	5.20	843.18
CRP Latex(HS) Serum	mg/L	0.9894	0.0444	0.9995	0.15	92.49

Table 9.3.1 Linearity Data

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9.4 Sensitivity (Detection Limits):

LoB, LoD and LoQ studies were designed primarily from CLSI quideline EP17-A2 " Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Approved Guideline - Second Edition. The experimental design consisted of replicate measurements on blank and low level samples using 2 lots of reagent across multiple days. A total of 60 blank replicates per reagent lot and 280 low level sample replicates per reagent lot were generated. This was comprised of 4 blank samples run 5-fold for 3 days, and 7 low level samples run 5-fold for 8 days.

The LoB, LoD, and LoQ results are summarised in the table below. All representative reagents met specifications and were below the claimed measuring range of the reagent.

Reagent	Units	Low End ofMeasuringRange	LoB	LoD	LoQ
Glucose,Serum	mg/dL	10	0	0.42	2.68
CRP Latex(HS), Serum	mg/L	0.2	0.04	0.08	0.08

Table 9.4.1 Sensitivity

0.5 Precision/Reproducibility:

Repeatability (within-run) and within-laboratory (total) precision studies were designed from CLSI guideline EP05-A3 "Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition". The precision was verified on the DxC 700 AU using 1 lot of reagent and 1 lot of calibrator and utilized duplicate sample analysis, twice daily, over the course of 20 days (n=80) for multiple sample levels. There was a minimum interval of two hours between the two runs each day.

All assays met the performance precision specifications and provide data to support the precision claims in the IFUs. The results are summarized in the below tables:

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Table 9.5.1. Precision

Reagent	SampleLevels	Mean	Repeatability(Within-run)		Within Laboratory(Total)
		(n=80)	SD	% CV	SD	% CV
CRP Latex(HS)(mg/L)	Serum 1	0.49	0.019	3.84	0.017	3.48
	Serum 2	10.28	0.120	1.17	0.125	1.22
	Serum 3	50.08	0.314	0.63	0.389	0.78
	Serum 4	67.82	0.428	0.63	0.612	0.90
Glucose(mg/dL)	Serum 1	25.87	0.326	1.26	0.628	2.43
	Serum 2	60.55	0.501	0.83	0.815	1.35
	Serum 3	101.73	0.754	0.74	1.184	1.16
	Serum 4	280.55	2.386	0.85	2.530	0.90
	Serum 5	643.89	4.269	0.66	4.821	0.75
Sodium(mEq/L)	Serum 1	61.83	0.324	0.52	0.879	1.42
	Serum 2	109.70	0.318	0.29	0.638	0.58
	Serum 3	139.51	0.212	0.15	0.552	0.40
	Serum 4	167.78	0.309	0.18	0.834	0.50
Potassium(mEq/L)	Serum 1	2.48	0.009	0.36	0.016	0.64
	Serum 2	4.56	0.011	0.25	0.022	0.48
	Serum 3	6.46	0.021	0.33	0.039	0.60
	Serum 4	8.35	0.035	0.42	0.080	0.96
Chloride(mEq/L)	Serum 1	76.47	0.149	0.19	0.510	0.67
	Serum 2	105.25	0.270	0.26	0.443	0.42
	Serum 3	151.82	0.401	0.26	1.025	0.68
Sodium(mEq/L)	Urine 1	21.98	0.261	1.19	0.414	1.89
	Urine 2	98.73	0.420	0.43	1.308	1.32
	Urine 3	245.49	0.951	0.39	3.191	1.30
	Urine 4	353.40	0.933	0.26	4.092	1.16
Potassium(mEq/L)	Urine 1	10.50	0.047	0.45	0.127	1.21
	Urine 2	33.62	0.128	0.38	0.611	1.82
	Urine 3	101.11	0.596	0.59	1.308	1.29
	Urine 4	171.44	1.145	0.67	2.435	1.42
Chloride(mEq/L)	Urine 1	25.50	0.173	0.68	0.559	2.19
	Urine 2	84.46	0.249	0.29	0.508	0.60
	Urine 3	148.47	0.383	0.26	0.758	0.51
	Urine 4	290.56	1.737	0.60	3.640	1.25
	Urine 5	364.05	1.716	0.47	4.157	1.14

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9.6 In-Use and Calibration Stability Verification (EP25-A):

This protocol followed CLSI EP25-A quideline "Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline"; The aim was to verify the 30 and 90 day on-board claim for the representative reagents and to verify the 1 day calibration stability claim for the ISEs on the DxC 700 analyzer.

Testing was performed using one reagent lot (where appropriate) and one calibrator lot on the DxC 700 analyzer. Calibration (as required) was performed on the initial day of testing and controls were run in duplicate. At each timepoint the reagents were calibrated (if required) and controls were run in duplicate. Controls were run in duplicate on Day 1 + greater than 2hrs for the ISEs. The mean of the control replicates was calculated and the bias of this result to the mean of the control on Day 0 was calculated. The final time-points exceeded the claims on the reagent and ISE IFUs. For the reagents, linearity was assessed at the final time point.

A summary of in-use and calibration stability specifications and results are detailed in the tables below. All results were within specification and provide data to support the on-board and calibrations stability claims in the reagent and ISE IFUs.

Reagent	Application	OnboardStabilityClaim(Days)	CalibrationStabilityClaim(Days)
CRP Latex(HS)	Serum	90	90
Glucose	Serum	30	30

Table 9.6.1 Reagent In-Use and Calibration Stability Specifications

Table 9.6.2 ISE Calibration Stability Specifications

Product Name	SampleType	CalibrationStability Claim(Days)
Sodium	Serum	1
Sodium	Urine	1
Potassium	Serum	1
Potassium	Urine	1
Chloride	Serum	1
Chloride	Urine	1

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9.7 Interferences (Analytical specificity):

Interference studies were designed based on CLSI Guideline EP07-A2: "Interference Testing in Clinical Chemistry: Approved Guideline - Second Edition".

All test samples were assayed in quadruplicate at two analyte levels. The sample pools tested were at different levels of interferents to determine the magnitude of their effect (if any). The data analysis involved calculating the difference in recovery of the samples with and without the potential interfering substances. The results are summarized below. All interferences met the required specifications on the DxC 700 AU analyzer.

Table 9.7.1 Chloride LIH Tolerance

SUBSTANCE	SOURCE	LEVELTESTED*	OBSERVEDEFFECT
Bilirubin (unconjugated)	Porcine	40 mg/dL	NSIa
Hemoglobin	RBC hemolysate	500 mg/dL	NSI
Lipemia	Intralipidb	500 mg/dL	NSI

Table 9.7.2 Potassium LIH Tolerance

SUBSTANCE	SOURCE	LEVELTESTED*	OBSERVEDEFFECT
Bilirubin (unconjugated)	Porcine	40 mg/dL	NSIa
Hemoglobin	RBC hemolysate	70 mg/dL	NSI
Lipemia	Intralipidb	500 mg/dL	NSI

Table 9.7.3 Sodium LIH Tolerance

SUBSTANCE	SOURCE	LEVELTESTED*	OBSERVEDEFFECT
Bilirubin (unconjugated)	Porcine	40 mg/dL	NSIa
Hemoglobin	RBC hemolysate	250 mg/dL	NSI
Lipemia	Intralipidb	500 mg/dL	NSI

*Level Tested represents the maximum concentration of interferent tested where no significant interference was observed.

a = NSI = No Significant Interference (Chloride ±2.5%, Potassium ±0.25 mEq/L, Sodium ±2mEq/L)

b = Intralipid is a registered trademark of KabiVitrum, Inc., Clayton, NC 27250

Table 9.7.4 Glucose and CRP (HS) Interference Data

	Interference Threshold
Reagent	*Lipemic(Intralipid) ±	Icteric(Unconjugated) ±	Hemolytic ±
Glucose,Serum	10% at700 mg/dL	10% at40 mg/dL	10% at500 mg/dL
CRP Latex(HS), Serum	Intralipid(1000 mg/dL)intf. < 10% at CRPconc. of1 mg/L	Bilirubin(40 mg/dL)intf. < 5% at CRPconc. of 1 mg/L	hemolysate (500mg/dL)intf. < 5% at CRPconc. Of1 mg/L

Claim based on Intralipid: a 20% IV fat emulsion used to emulate extremely turbid samples.

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9.8 Prozone

Testing was carried out to verify the prozone performance on the DxC 700 AU using CRP Latex (High Sensitivity application) as the representative assay. Human serum was spiked with human CRP to create a prozone high pool of > 750 mg/L. The CRP concentration was verified using three replicates of three dilutions within the measuring range. Eleven dilutions of the high prozone pool were then prepared and ran n=3 to confirm prozone performance. Testing demonstrates that samples with CRP concentrations up to 750 mg/L will not generate falsely low results within the analytical range.

10.0 Conclusion

The submission provides the data necessary to demonstrate this equivalence based on the performance validations and comparisons conducted between the representative reagents and analyzer platforms. Based on this data, the new DxC 700 AU Chemistry Analyzer is substantially equivalent to the referenced predicate(s).

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.