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

K161837 · Beckman Coulter, Inc. · JGS · Dec 16, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161837
• Device Name: ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
• Applicant: Beckman Coulter, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Dec 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

DxC 700 AU Clinical Chemistry Analyzer is a fully automated, random-access system for in vitro diagnostic testing. It processes serum, plasma, urine, and CSF samples. The system utilizes ion-selective electrodes (ISE) for electrolytes (Na+, K+, Cl-), colorimetric enzymatic assays for glucose, and latex agglutination for hs-CRP. Samples are loaded via racks or STAT table; the analyzer aspirates samples and reagents, performs automated mixing and incubation, and measures absorbance or electrical potential. The system uses a halogen lamp (340-800 nm) for photometric detection. Results are displayed to clinicians to aid in diagnosing metabolic disorders, electrolyte imbalances, and cardiovascular risk. The device is intended for clinical laboratory use by trained personnel. It supports barcode-based sample identification and automated reagent management. The system provides quantitative data to support clinical decision-making regarding patient treatment and monitoring.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP05-A3, EP06-A, EP07-A2, EP09-A3, EP17-A2, EP28-A3c). Precision studies (N=80 per analyte) showed low CVs. Linearity confirmed across claimed ranges (r > 0.999). Method comparison against AU5800 (N > 100 samples per analyte) showed high correlation (slope 0.98-1.03, r > 0.999). Matrix comparison (serum vs. plasma) confirmed equivalence. No clinical trials performed.

Technological Characteristics

Automated discrete photometric chemistry analyzer. Sensing: Ion Selective Electrodes (crown ether/PVC membranes) for electrolytes; colorimetric enzymatic for glucose; latex agglutination for CRP. Energy: Halogen lamp (340-800 nm). Connectivity: Barcode-based sample/reagent identification. Throughput: 800-1200 tests/hour. Software: Automated analysis, calibration, and QC monitoring.

Indications for Use

Indicated for quantitative measurement of sodium, potassium, chloride, glucose, and C-reactive protein (CRP) in human serum, plasma, urine, and cerebrospinal fluid (glucose only). Used for diagnosis/treatment of electrolyte/metabolic disorders, diabetes, cardiovascular risk assessment, and inflammatory conditions. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• ISE Reagents : Potassium, Sodium and Chloride (K003721)
• ISE Reagents : Potassium (K112412)
• Glucose (K112412)
• OLYMPUS CRP Latex Immunoturbidimetric Reagent (K051564)
• AU5800 Clinical Chemistry Analyzer (K112412)

Submission Summary (Full Text)

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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 [phone] or [phone] 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

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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)

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.

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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Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape on the left, with two curved white lines running through it. To the right of the oval is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The word "BECKMAN" is placed above the word "COULTER."

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: [phone] Fax: [phone]

# 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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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, followed by the company name "BECKMAN COULTER" in black, with "BECKMAN" on the top line and "COULTER" on the bottom line. The font is bold and sans-serif.

# 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 and<br>Chloride | ISE Reagents : Potassium,<br>Sodium and Chloride<br>(K003721) | Beckman Coulter,<br>Inc. |
| ISE Reagents : Potassium | ISE Reagents : Potassium<br>(K112412) | Beckman Coulter,<br>Inc. |
| Glucose | Glucose<br>(K112412) | Beckman Coulter,<br>Inc. |
| CRP Latex | OLYMPUS CRP Latex<br>Immunoturbidimetric Reagent<br>(K051564) | Beckman Coulter,<br>Inc. |
| DxC 700 AU Clinical<br>Chemistry Analyzer | AU5800 Clinical Chemistry<br>Analyzer<br>(K112412) | Beckman Coulter,<br>Inc. |

## 5.0 Device Description

# 5.1 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.

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

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).

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Image /page/6/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, placed to the left of the company name. The text "BECKMAN" is stacked on top of "COULTER" in a bold, sans-serif font.

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

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).

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 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

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Image /page/7/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, placed to the left of the company name. The text "BECKMAN" is on the top line, and "COULTER" is on the bottom line, with both words in a bold, sans-serif font.

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

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.

# 6.4 DxC 700 AU Clinical Chemistry Analyzer

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.

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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 on the left side, with two white curved lines inside. To the right of the oval is the company name, "BECKMAN COULTER," written in bold, black letters. The word "BECKMAN" is on the top line, and "COULTER" is on the bottom line.

# 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:<br>ISE Reagents – Sodium and<br>Chloride<br>(K003721) | Proposed Device:<br>ISE Reagents - Sodium and<br>Chloride |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Item Number | AUH1011, AUH1012, AUH1013,<br>AUH1014, AUH1015, AUH1016,<br>AUH1017, AUH1018 | Same |
| Intended Use | Reagent for the quantitative<br>determination of Sodium,<br>Potassium and Chloride<br>concentrations in human serum<br>and urine on the Beckman<br>Coulter ISE modules. | Same |
| Measurement | Quantitative | Same |
| Instrument<br>Required | AU400/400°, AU600/640/640°,<br>AU800,AU1000, AU5200 and<br>AU2700 Beckman Coulter<br>Analyzers | AU400/400°/480,<br>AU600/640/640°/680,<br>AU2700/5400/AU5800 and DxC<br>700 AU Beckman Coulter<br>Analyzers. |
| Methodology | Indirect ISE | Same |
| Reagent form and<br>storage | Liquid, on-board storage | Same |
| Specimen Type | Serum, plasma and urine | Same |
| Calibrator | AUH1014 Low Serum Standard<br>AUH1015 High Serum Standard<br>AUH1016 High/Low Urine<br>Standard | Same |
| Calibration Stability | Calibrate daily. | Same |
| Reagent stability | AUH1011, AUH1012, and<br>AUH1013 are stable for 90 days<br>when opened and stored in the<br>ISE reagent compartment of the<br>analyzer.<br>After opening AUH1014,<br>AUH1015, AUH1016, and<br>AUH1018 may be stored at 2 -<br>25°C for up to 90 days, provided<br>the cap is replaced immediately<br>after each use. After opening,<br>AUH1017 may be stored at 15 -<br>25°C for up to 90 days. | Same |
| Feature | Predicate Device:<br>ISE Reagents - Sodium and<br>Chloride<br>(K003721) | Proposed Device:<br>ISE Reagents - Sodium and<br>Chloride |
| Analytic Range | Serum<br>$Na^+ 50 - 200$ mEq/L<br>$Cl^- 50 - 200$ mEq/L<br>Urine<br>$Na^+ 10 - 400$ mEq/L<br>$Cl^- 15 - 400$ mEq/L | Same |

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

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Image /page/9/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, placed to the left of the company name. The text "BECKMAN COULTER" is written in bold, black letters, with "BECKMAN" on the top line and "COULTER" on the bottom line.

# 7.2 ISE Reagents (Potassium) Predicate Device Comparison Table

| Feature | Predicate Device:<br>ISE Reagents - Potassium<br>(K112412) | Proposed Device:<br>ISE Reagents – Potassium |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Item Number | AUH1011, AUH1012, AUH1013,<br>AUH1014, AUH1015, AUH1016,<br>AUH1017, AUH1018 | Same |
| Intended Use | Reagent for the quantitative<br>determination of Sodium,<br>Potassium and Chloride<br>concentrations in human serum<br>and urine on the Beckman<br>Coulter ISE modules. | Same |
| Measurement | Quantitative | Same |
| Instrument<br>Required | AU400/400e/480,<br>AU600/640/640o/680 and<br>AU2700/5400/AU5800 Beckman<br>Coulter Analyzers | AU400/400e/480,<br>AU600/640/640o/680,<br>AU2700/5400/AU5800 and DxC<br>700 AU Beckman Coulter<br>Analyzers. |
| Methodology | Indirect ISE | Same |
| Reagent form and<br>storage | Liquid, on-board storage | Same |
| Specimen Type | Serum, plasma and urine | Same |
| Calibrator | AUH1014 Low Serum Standard<br>AUH1015 High Serum Standard<br>AUH1016 High/Low Urine<br>Standard | Same |
| Calibration Stability | Calibrate daily. | Same |
| Reagent stability | AUH1011, AUH1012, and<br>AUH1013 are stable for 90 days<br>when opened and stored in the<br>ISE reagent compartment of the<br>analyzer.<br>After opening AUH1014,<br>AUH1015, AUH1016, and<br>AUH1018 may be stored at 2 –<br>25°C for up to 90 days, provided<br>the cap is replaced immediately<br>after each use. After opening,<br>AUH1017 may be stored at 15 –<br>25°C for up to 90 days. | Same |

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Image /page/10/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 letter "B". To the right of the oval is the company name, "BECKMAN COULTER", written in bold, black capital letters. The overall design is clean and professional.

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

# 7.3 Glucose Predicate Device Comparison Table

| Feature | Predicate Device:<br>Glucose<br>(K112412) | Proposed Device:<br>Glucose |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Item Number | Glucose (OSR6121, OSR6221,<br>OSR6621) | Same |
| Intended Use | System reagent for the<br>quantitative determination of<br>Glucose in human serum,<br>plasma, urine and cerebrospinal<br>fluid on Beckman Coulter AU<br>analyzers. | Same |
| Measurement | Quantitative | Same |
| Instrument<br>Required | AU400/400 e/480,<br>AU600/640/6406/680 and<br>AU2700/5400/AU5800 Beckman<br>Coulter Analyzers | AU400/400 e/480,<br>AU600/640/6406/680,<br>AU2700/5400/AU5800 and DxC<br>700 AU Beckman Coulter<br>Analyzers. |
| Methodology | Photometric | Same |
| Reagent form and<br>storage | Liquid, on-board storage | Same |
| Specimen Type | Serum, plasma, urine and<br>cerebrospinal fluid | Same |
| Calibrator | Chemistry Calibrator (Cat #<br>DR0070)<br>Urine Calibrator (Cat # DR0090) | Same |
| Calibration<br>Stability | 30 days | Same |
| Onboard Stability | 30 days refrigerated | Same |
| Analytic Range | Serum, plasma and CSF:<br>10 - 800 mg/dL<br>Urine:<br>10 - 700 mg/dL | Same |

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Image /page/11/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" are stacked on top of "COULTER" in a bold, sans-serif font.

| Feature | Predicate Device:<br>CRP Latex | Proposed Device: |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (K051564) | CRP Latex |
| Item Number | CRP Latex (OSR6199) | Same |
| Intended Use | Olympus System Reagent and<br>calibrators for the quantitative<br>determination of C-Reactive<br>Protein in human serum and<br>plasma on OLYMPUS<br>Analyzers. Measurement of<br>CRP is useful for the detection<br>and evaluation of infection,<br>tissue injury, inflammatory<br>disorders and associated<br>diseases. Measurements may<br>also be used as an aid in the<br>identification of individuals at<br>risk of future cardiovascular<br>disease. High sensitivity CRP<br>(hsCRP) measurements, when<br>used in conjunction with<br>traditional clinical laboratory<br>evaluation of acute coronary<br>syndromes, maybe useful as<br>an independent marker of<br>prognosis for recurrent events,<br>in patients with stable coronary<br>disease or acute coronary<br>syndromes. | Same<br>System reagent for the<br>quantitative determination of<br>C-Reactive Protein in human<br>serum and plasma on<br>Beckman Coulter AU<br>Analyzers. Measurement of<br>CRP is useful for the detection<br>and evaluation of infection,<br>tissue injury, inflammatory<br>disorders and associated<br>diseases. Measurements may<br>also be useful as an aid in the<br>identification of individuals at<br>risk for future cardiovascular<br>disease. High sensitivity CRP<br>(hsCRP) measurements, when<br>used in conjunction with<br>traditional clinical laboratory<br>evaluation of acute coronary<br>syndromes, may be useful as<br>an independent marker of<br>prognosis for recurrent events,<br>in patients with stable coronary<br>disease or acute coronary<br>syndromes. |
| Measurement | Quantitative | Same |
| Instrument Required | AU400/400°/480,<br>AU600/640/640°/680 and<br>AU2700/5400/AU5800<br>Beckman Coulter Analyzers | AU400/400°/480,<br>AU600/640/640°/680,<br>AU2700/5400/AU5800 and<br>DxC 700 AU Beckman Coulter<br>Analyzers. |
| Methodology | Latex enhanced<br>Immunoturbidimetric | Same |
| Antibody | Rabbit Anti-CRP Antibodies | Same |
| Reagent form and<br>storage | Liquid, on-board storage | Same |
| Specimen Type | Serum and plasma | Same |
| Calibrator | CRP Latex Highly Sensitive<br>Calibrator (Cat # ODC0027)<br>for the Highly Sensitive<br>(Cardiac / Neonatal)<br>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:<br>AU5800 Clinical Chemistry<br>Analyzer<br>(K112412) | Proposed Device:<br>DXC 700 AU Clinical<br>Chemistry Analyzer |
| Intended Use: | The Beckman Coulter AU5800<br>Clinical Chemistry Analyzer is an<br>automated chemistry analyzer<br>that measures analytes in<br>samples, in combination with<br>appropriate reagents,<br>calibrators, quality control (QC)<br>material and other accessories.<br>This system is for in vitro<br>diagnostic use only.<br>Applications include colorimetric,<br>turbidimetric, latex agglutination,<br>homogeneous enzyme<br>immunoassay, and ion selective<br>electrode. | Similar to predicate.<br>The Beckman Coulter DxC 700<br>AU Clinical Chemistry Analyzer<br>is an automated chemistry<br>analyzer that measures analytes<br>in samples, in combination with<br>appropriate reagents,<br>calibrators, quality control (QC)<br>material and other accessories.<br>This system is for in vitro<br>diagnostic use only.<br>Applications include colorimetric,<br>latex agglutination and ion<br>selective electrode. |
| Classification: | Analyzer, chemistry<br>(photometric, discrete), for<br>clinical use has been classified<br>as Class I, JJE by the Clinical<br>Chemistry and Clinical<br>Toxicology Devices Panel, (21<br>CFR 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,<br>Direct-line Sample Aspiration<br>(For Automation Connections) |
| Single Sample<br>Replicate Analysis | None. | Ability to request test replicates<br>for one sample, up to 20<br>replicates per sample per test. |
| Sample Analysis | | |
| Wavelength (nm) | Halogen Lamp<br>340 to 800 nm<br>13 wavelengths:<br>340, 380, 410, 450, 480, 520,<br>540, 570, 600, 660, 700, 750<br>and 800 nm (maximum of 2<br>wavelengths) | Identical to predicate. |
| Type of<br>Measurement | • End point assay<br>• Rate assay<br>• Fixed point assay<br>• Electrode method (ISE) | Identical to predicate. |
| Throughput | Maximum 2000 photometric<br>tests/hour/unit | Maximum 800 photometric<br>tests/hour or 1200 tests/hour<br>(photometric + ISE) |
| Feature | Predicate Device:<br>AU5800 Clinical Chemistry<br>Analyzer<br>(K112412) | Proposed Device:<br>DxC 700 AU Clinical<br>Chemistry Analyzer |
| Reagent Handling | | |
| Reagent<br>Identification | Ba…