Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard chemical and photometric analysis techniques, ion-selective electrodes, and immunological reactions. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.

Therapeutic

No
This device is an in vitro diagnostic (IVD) chemistry analyzer that measures analytes in patient samples (e.g., blood, urine) for diagnostic purposes. It does not directly provide therapy or treatment.

Diagnostic

Yes

The document explicitly states that the "DxC 500 AU Clinical Chemistry Analyzer ... is for in vitro diagnostic use only." It also details how measurements obtained by the device are "used in the diagnosis and treatment" of various conditions like carbohydrate metabolism disorders, aldosteronism, diabetes insipidus, electrolyte imbalances, infection, tissue injury, and inflammatory disorders.

SaMD (Software as a Medical Device)

No

The device is a physical clinical chemistry analyzer that measures analytes in samples using hardware components like photometric systems and ion-selective electrodes, in combination with reagents and calibrators. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This system is for in vitro diagnostic use only."
Nature of Measurements: The device measures analytes (glucose, C-Reactive Protein, Sodium, Potassium, Chloride) in human biological samples (serum, plasma, urine, cerebrospinal fluid). This is the core function of an in vitro diagnostic device.
Purpose of Measurements: The measurements are used "in the diagnosis and treatment" of various medical conditions, which is the intended purpose of an IVD.
Device Description: The "Device Description" further reinforces this by describing it as an "automated photometric clinical analyzer that measures analytes in samples" and reiterating "This system is for in vitro diagnostic use only."
Reagent Description: The descriptions of the reagents (Glucose test system, CRP Latex reagent, Sodium, Potassium, and Chloride reagents) also specify their use "for the quantitative measurement" of these analytes in human samples and, in the case of the CRP reagent, explicitly states it is an "in vitro diagnostic device."

All these points clearly indicate that the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is designed and intended for use in performing diagnostic tests on samples taken from the human body, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Beckman Coulter DxC 500 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.

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

Product codes (comma separated list FDA assigned to the subject device)

JGS, CEM, CGZ, CFR, NQD, DCN, JJE

Device Description

The Beckman Coulter DxC 500 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 photometric clinical 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. Electrolyte measurement is performed using a single cell lon 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-6phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH). The change in absorbance at 340/660 nm is proportional to the amount of glucose present in the sample.

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. In this procedure, the measurement of the rate of decrease in light intensity transmitted through particles suspended in solution is the result of complexes formed during the immunological reaction between the CRP of the patient serum and rabbit anti-CRPantibodies coated on latex particles. Two measuring range settings are available: Normal application (CRP Concentrations ranging between 5.0-480 mg/L) and Highly Sensitive (Cardiac) Application- (CRP concentrations ranging between 0.2-80mg/L).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Method Comparison:
Method comparison and bias estimation experiments were designed in accordance with the CLSI Guideline EP09C-ED3 "Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition". The patient correlation studies demonstrated equivalence between the representative assays on the candidate DxC 500 AU analyzer and the predicate DxC 700 AU analyzer. The study results in Table 9.1 are based on Weighted Deming regression analysis.
For hsCRP (Cardiac), Sample Type Serum, N=115, Slope=0.990, Bias=0.4% at 3mg/L, Intercept=0.0421, R=0.9997.
For CRP Normal, Sample Type Serum, N=120, Slope=0.993, Bias=5.4% at 10 mg/L, Intercept=0.606, R=0.9995.
For Glucose, Sample Type Serum, N=133, Slope=0.986, Bias=-1% at 100 mg/dL, Intercept=0.227, R=0.9999.
For Glucose, Sample Type Urine, N=113, Slope=1.001, Bias=-0.3% at 50 mg/dL, Intercept=-0.216, R=1.0000.
For Glucose, Sample Type CSF, N=111, Slope=1.009, Bias=3% at 50 mg/dL, Intercept=0.891, R=0.9998.
For ISE Sodium, Sample Type Serum, N=120, Slope=1.018, Bias=0.2% at 130 mEq/L; 0.5% at 160 mEq/L, Intercept=-2.077, R=0.9995.
For ISE Potassium, Sample Type Serum, N=119, Slope=1.015, Bias=-0.1% at 3 mEq/L; 0.7% at 6 mEq/L, Intercept=-0.048, R=0.9998.
For ISE Chloride, Sample Type Serum, N=120, Slope=1.007, Bias=0.3% at 90 mEq/L; 0.4% at 120 mEq/L, Intercept=-0.379, R=0.9997.
For ISE Sodium, Sample Type Urine, N=117, Slope=1.008, Bias=0.6% at 60 mEq/L; 0.7% at 180 mEq/L, Intercept=-0.150, R=0.9999.
For ISE Potassium, Sample Type Urine, N=120, Slope=1.000, Bias=1.3% at 15 mEq/L; 0.2% at 80 mEq/L, Intercept=0.194, R=0.9998.
For ISE Chloride, Sample Type Urine, N=114, Slope=1.002, Bias=-0.4% at 50 mEq/L; 0.05% at 170 mEq/L, Intercept=-0.291, R=0.9999.

Linearity/Reportable Range:
Analytical range (linearity) studies were designed in accordance with the CLSI guideline EP06-ED2 "Evaluation of the Linearity of Quantitative Measurement Procedures". High and low sample pools were prepared and inter-diluted to achieve analyte concentrations spanning the claimed linear range of each assay. Test samples were assayed in quadruplicate on the DxC 500 AU analyzer. The study data demonstrates linearity throughout the claimed analytical measuring range of each assay.

Sensitivity (Detection Limits):
LOD and LOQ studies were designed in accordance with CLSI guideline 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 across multiple days using multiple reagent lots. The representative reagents met the established LOQ specifications when tested on the DxC 500 AU analyzer, and the LOQ results were below the claimed measuring range for each assay.

Precision/Reproducibility:
Repeatability (within-run) and within-laboratory (total) precision studies were designed from the CLSI guideline EP05-A3 "Evaluation of Quantitative Measurement Procedures; Approved Guideline - Third Edition". The precision was verified on the DxC 500 AU using one lot of reagent and one lot of calibrator and utilized duplicate sample analysis, twice daily, over the course of 20 days (n=80) for multiple sample levels. All assays met the performance precision specifications and provided data to support the precision claims in the IFUs.

Interferences (Analytical Specificity):
Interference studies were designed in accordance with CLSI Guideline EP07, 3rd Edition "Interference Testing in Clinical Chemistry; Approved Guideline". All test samples were assayed (n=5) at two analyte levels. The sample pools were tested at different levels of interferents to determine the magnitude of their effect. The data analysis involved calculating the recovery difference between samples with and without the potential interfering substances. All assays met the performance specifications and provided data to support the interference claims in the IFUs.

Reference Interval:
The Reference Interval study utilized a transference approach in accordance with the CLSI guideline EP028-A3c "Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition". The purpose of the study was to validate the acceptability of the original adult reference intervals for use on the candidate DxC 500 AU analyzer. The use of a transference approach was based on the demonstrated comparability between the candidate and predicate tests systems via the CLSI EP09c study.The approach used a sampling of at least 20 reference individuals to verify that ≥ 90% of the test samples recovered within the reference intervals cited in the respective assay IFUs. Verification studies were not performed for sample types difficult to source (CSF and 24hour urine collections); these applications are supported by the original literature references in their IFUs.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics reported are related to Linearity, Sensitivity (LOD, LOQ), Precision (Repeatability and Within Laboratory %CV and SD), and Interference. Specificity, PPV, NPV not explicitly mentioned beyond the interference study which checks analytical specificity.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161837

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.

July 20, 2023

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Tracy Jin Sr. Regulatory Affairs No. 181 West Su Hong Road. Suzhou Industrial Park Suzhou, Jiangsu, CN 215021 China

Re: K220977

Trade/Device Name: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, CEM, CGZ, CFR, NQD, DCN, JJE Dated: January 12, 2023 Received: January 12, 2023

Dear Tracy Jin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part

1

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Paula V. Caposino -2

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K220977

Device Name

DxC 500 AU Clinical Chemistry Analyzer; Glucose; CRP Latex; ISE Reagents

Indications for Use (Describe)

The Beckman Coulter DxC 500 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.

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

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.

3

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Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other in black, bold font. The logo is simple and modern, with a focus on the company name.

1.0 Submitted By

Tracy Jin Sr. Regulatory Affairs Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. No. 181 West Su Hong Road, Suzhou Industrial Park, Suzhou, Jiangsu, CN 215021 Telephone: 86-512- 6895 5129 Fax: 86-512-6742 1069

2.0 Date of Preparation

July 19, 2023

3.0 Device Name(s)

DxC 500 AU Clinical Chemistry Analyzer 3.1

Proprietary Name:	DxC 500 AU Clinical Chemistry Analyzer
Common Name:	DxC 500 AU
510 (K) Number:	K220977
Class:	Class I
Classification Name:	Discrete photometric chemistry analyzer for clinical use
Regulation Number:	21 CFR § 862.2160
Product Code:	JJE

3.2 ISE Reagents

Proprietary Name:	ISE Reagents
Common Name:	ISE Reagents

Class: Class II 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]

3.3 Glucose

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

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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized wave or ribbon. To the right of the circle are the words "BECKMAN" and "COULTER" stacked vertically, both in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.

3.4 CRP Latex

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

4.0 Predicate Devices

Candidate(s)	Predicate	Manufacturer
DxC 500 AU Clinical
Chemistry Analyzer	DxC 700 AU Clinical Chemistry
Analyzer
(K161837)	Beckman Coulter,
Inc.
ISE Reagents:
Sodium, Potassium and
Chloride	ISE Reagents:
Sodium, Potassium and Chloride
(K161837)
Glucose	Glucose
(K161837)
CRP Latex	CRP Latex
(K161837)

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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other in black font. The logo is simple and modern, with a focus on the company name.

5.0 Device Description

5.1 DxC 500 AU Clinical Chemistry Analyzer

The Beckman Coulter DxC 500 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 photometric clinical 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. Electrolyte measurement is performed using a single cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

5.2 ISE Reagents

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.

5.3 Glucose

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-6phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH). The change in absorbance at 340/660 nm is proportional to the amount of glucose present in the sample.

5.4 CRP Latex

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. In this procedure, the measurement of the rate of decrease in light intensity transmitted through particles suspended in solution is the result of complexes formed during the immunological reaction between the CRP of the patient serum and rabbit anti-CRPantibodies coated on latex particles. Two measuring range settings are available: Normal application (CRP Concentrations ranging between 5.0-480 mg/L) and Highly Sensitive (Cardiac) Application- (CRP concentrations ranging between 0.2-80mg/L).

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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized wave or ribbon. To the right of the circle are the words "BECKMAN" and "COULTER" stacked vertically, both in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.

6.0 Indications for Use

DxC 500 AU Clinical Chemistry Analyzer 6.1

The Beckman Coulter DxC 500 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.

6.2 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 sodium test system is intended for the quantitative measurement of 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.

6.3 Glucose

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

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Image /page/8/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 written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.

6.4 CRP Latex

System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU/DxC 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.

7.0 Comparison to the Predicate

The DxC 500 AU Clinical Chemistry Analyzer is a member of Beckman Coulter's AU/DxC AU series of automated photometric analyzers that includes the DxC 700 AU Clinical Chemistry Analyzer (K161837) to which the substantial equivalence is claimed. The devices share common design characteristics and modes of operation. The key features are summarized in Tables 7.1 through 7.4.

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Image /page/9/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name in black text. The word "BECKMAN" is on top of the word "COULTER".

	Predicate Device:	Predicate Device:
Feature	DxC 700 AU Clinical
Chemistry Analyzer
(K161837)	DxC 500 AU Clinical
Chemistry Analyzer
(K220977)
Intended Use:	Automated chemistry
analyzer that measures
analytes in samples, in
combination with appropriate
reagents, calibrators, quality
control (QC) material and
other accessories. For in vitro
diagnostic use only.
Applications include
colorimetric, latex
agglutination and ion
selective electrode.	Same (removal of test
applications only):
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.
Classification:	Analyzer, chemistry
(photometric, discrete), for
clinical use has been
classified as Class I, JJE by
the Clinical Chemistry and
Clinical Toxicology Devices
Panel, (21 CFR 862.2160).	Same
Sample Handling
Sample Containers	10 sample tubes on a Rack	7 sample tubes on a Rack
Sample Volume	1.0 to 25.0 µL	Same
Sample Types	Serum, plasma, urine, CSF,
and whole blood (HbA1c
only)	Same
Sample Input	Sample Rack, STAT Table,
Direct-line Sample Aspiration
(For Automation
Connections)	Sample Rack, STAT Table
	Predicate Device:	Candidate Device:
Feature	DxC 700 AU Clinical
Chemistry Analyzer
(K161837)	DxC 500 AU Clinical
Chemistry Analyzer
(K220977)
Single Sample
Replicate Analysis	Ability to request test
replicates for one sample, up
to 20 replicates per sample
per test.	Same
Sample Analysis
Wavelength (nm)	Halogen Lamp
340 to 800 nm
13 wavelengths:
340, 380, 410, 450, 480, 520,
540, 570, 600, 660, 700, 750
and 800 nm (maximum of 2
wavelengths)	Same
Type of Measurement	• End-point assay
• Rate assay
• Fixed point assay
• Electrode method (ISE)	Same
Throughput	Maximum 800 photometric
tests/hour or 1200 tests/hour
(photometric + ISE)	Maximum 400 photometric
tests/hour or 800 tests/hour
(photometric + ISE)
Reagent Handling
Reagent Identification	Barcode and fixed position in
the reagent carousel	Same
Refrigerated Reagent
On-board Capacity	System has two Reagent
Refrigerators:
Reagent 1: 60 bottle capacity
Reagent 2: 48 bottle capacity	System has one Reagent
Refrigerator with 76 bottle
capacity (Reagent 1+Reagent