AU5800(R) CHEMISTRY ANALYZER

K112412 · Beckman Coulter, Inc. · CEM · Dec 23, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112412
• Device Name: AU5800(R) CHEMISTRY ANALYZER
• Applicant: Beckman Coulter, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium 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, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, 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 hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Potassium test system is 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 diseases conditions characterized by low or high blood potassium levels. The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Device Story

Fully automated, random access clinical chemistry analyzer for ultra-high throughput laboratories; available in configurations from one to four photometric modules. Inputs: serum, plasma, urine, or other body fluids. Operation: automated analysis using colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, or ion selective electrode (ISE) methods. System uses reagents, calibrators, and QC materials common to the AU series. Output: quantitative analyte results generated automatically. Used by laboratory technicians/staff to monitor patient health, diagnose metabolic disorders, and manage electrolyte balance. Benefits: high-throughput processing, reliable results, and standardized reference ranges across the AU family.

Clinical Evidence

Bench testing only. Precision evaluated over 20 days (N=40-60) showing CVs <2.1%. Linearity confirmed across claimed ranges. Method comparison against predicate analyzers (AU2700/AU680) using 109-200 patient samples showed high correlation (R > 0.998). Interference testing confirmed <10% bias for common substances (lipemia, bilirubin, hemolysis). No clinical studies performed.

Technological Characteristics

Fully automated, random access photometric analyzer. Uses halogen lamp (340-800 nm) and ISE for electrolyte measurement. Glass cuvettes (500 uL capacity, 5mm light path). Modular design (1-4 modules). Connectivity: automated barcode sample recognition. Reagent capacity: 54 bottles per reagent position. Software-controlled automated analysis.

Indications for Use

Indicated for quantitative measurement of glucose, magnesium, and potassium in human serum, plasma, urine, and cerebrospinal fluid (glucose only) to aid in diagnosis and treatment of metabolic disorders, electrolyte imbalances, and pancreatic conditions.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• Beckman Coulter, AU2700 Clinical Chemistry System (k003721)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k112412

B. Purpose for Submission:
New Clinical Chemistry Analyzer

The sponsor selected three representative analytes (Glucose, Magnesium and Potassium) to show that these previously cleared reagents have the same performance characteristics on the new AU5800 analyzer as compared to the previously marketed AU series of chemistry analyzers.

C. Measurand:
Glucose, Magnesium, Potassium

D. Type of Test:
Quantitative, photometric and ion selective electrodes

E. Applicant:
Beckman Coulter, Inc.

F. Proprietary and Established Names:
AU5800 Clinical Chemistry Analyzer

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CEM | Class II | 21 CFR 862.1600
Potassium test system | Clinical Chemistry (75) |
| CFR | Class II | 21 CFR 862.1345
Glucose test system | Clinical Chemistry (75) |
| JGJ | Class I, reserved | 21 CFR 862.1495
Magnesium test system | Clinical Chemistry (75) |
| JJE | Class I | 21 CFR 862.2160
Discrete photometric | Clinical Chemistry (75) |

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| | | chemistry analyzer for clinical use | |
| --- | --- | --- | --- |

## H. Intended Use:

1. Intended use(s):

Refer to indications for use below.

2. Indication(s) for use:

The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium 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, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, 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 hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Potassium test system is 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 diseases conditions characterized by low or high blood potassium levels.

The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

3. Special conditions for use statement(s):

For in vitro diagnostic use only.

For prescription use.

4. Special instrument requirements:

AU5800 Clinical Chemistry Analyzer

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I. Device Description:

The Beckman Coulter AU5800 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, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode. Electrolyte measurement is performed using a single or double cell Ion Selective Electrode (ISE) which is also common among the other members of the AU family.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Beckman Coulter, AU2700 Clinical Chemistry System

2. Predicate 510(k) number(s):

k003721

3. Comparison with predicate:

| Feature | Proposed Device: AU5800 Clinical Chemistry Analyzer | Predicate Device: AU2700 Clinical Chemistry System |
| --- | --- | --- |
| Intended Use: | The Beckman Coulter AU5800 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, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode. | Same |
| Sample Types: | Blood serum, urine, CSF, or Plasma | Same |
| Assay Type: | End Point, Kinetic, Ions Selective Electrode (ISE) Optional.
Applications:
Colorimetric, Turbidimetric, Latex Agglutination, Homogenous EIA. | Same |
| Reactant Volume: | 80μl to 287μl | 120μl to 430μl |
| Sample Volume | 1.0 to 17.0 uL | 1.6uL to 25.0 uL |
| Prevention of Sample Carry Over | Same as AU2700
New function: extra optional DI wash sequence | Deionized Water Wash with Contamination Avoidance Parameters and enhanced washing sequence |

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| Feature | Proposed Device: AU5800 Clinical Chemistry Analyzer | Predicate Device: AU2700 Clinical Chemistry System |
| --- | --- | --- |
| Recognition of Sample | Read from the barcode | Same |
| Reagent On-board chemistries | Reagent 1 – 54 bottle capacity
Reagent 2 – 54 bottle capacity | Reagent 1 – 48 bottle capacity
Reagent 2 – 48 bottle capacity |
| Reagent Bottle | Reagent bottles with a capacity of 15mL, 30 mL, 60 mL, 120mL, 180mL | Same |
| Reagent Volume
Normal Pipette
Diluent Volume | 10 to 170 μL (can be set by 1uL)
0,10 to 160 uL (can be set by 1uL)
Max (reagent+diluent) less than 170uL | 15 to 250 μL (can be set by 1uL)
0,10 to 235 uL (can be set by 1uL)
Max (reagent+diluent) less than 250uL |
| Wave length (nm) | Halogen Lamp
340 to 800 nm
13 wavelengths: 340, 380, 410, 450, 480, 520, 540, 570, 600, 660, 700, 750 and 800 nm | Same |
| Cuvette | Square, glass cuvette
4 x 5 mm (Inside)
Capacity: 500 uL
Light Path: 5mm | Square, glass cuvette
6x5 mm (Inside)
Capacity: 750 uL
Light Path: 6mm |
| Cycle time of photometry measuring point | 28 points in 8.5 minutes (±.5 min) | Same |

The AU5800 analyzer utilizes the same cleared reagents as the predicate analyzer. Potassium reagent was cleared in k921718; Magnesium reagent was cleared in k944407; Glucose reagent was cleared in k944406/k924601.

## K. Standard/Guidance Document Referenced (if applicable):

1. CLSI EP5-A2. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.
2. CLSI EP07-A2. Interference Testing in Clinical Chemistry
3. CLSI EP9-A2. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline.
4. CLSI EP17-A. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.
5. IEC 61010-1. Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
6. IEC 61326. Electrical equipment for measurement, control and laboratory use-EMC requirement 2005.

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L. Test Principle:

Glucose:

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 change in absorbance at 340/380 nm is proportional to the amount of glucose present in the sample.

Magnesium:

The Magnesium procedure utilizes a direct method in which magnesium forms a colored complex with xylidyl blue in a strongly basic solution, where calcium interference is eliminated by glycoletherdiamine-N,N,N',N'-tetraacetic acid (GEDTA).3,4,5 The color produced is measured bichromatically at 520/800 nm and is proportional to the magnesium concentration.

Potassium:

The ISE module for K⁺ employs crown ether membrane electrodes that are specific for K⁺ ion in the sample. An electrical potential is developed according to the Nernst Equation. When compared to the Internal Reference Solution, this electrical potential is translated into voltage and then into the K⁺ ion concentration of the sample.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

The purpose of the performance studies was to validate that these previously cleared reagents have the same performance characteristics on the proposed new analyzer (AU5800) as compared to the previously marketed AU family of chemistry analyzers. The sponsor has chosen three representative analytes, Potassium, Magnesium, and Glucose using serum as the representative sample matrix.

a. Precision/Reproducibility:

Validation of precision on AU5800 were carried out using 2 or 3 levels of serum control pools, each sample was measured in duplicate in each run, two runs per day over a period of 20 days. The mean, standard deviation (SD), and coefficients of variation (CV) were determined for each control level and for each assay. The results are summarized in the below tables:

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Validation of precision performance for Potassium across several cells on AU5800.

| Analyzer Cell | Units* | Mean | Within Run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV % | SD | CV % |
| Cell 1 | mEq/L | 6.124 | 0.038 | 0.6 | 0.048 | 0.8 |
| | | 3.089 | 0.026 | 0.9 | 0.033 | 1.1 |
| Cell 2 | mEq/L | 6.155 | 0.048 | 0.8 | 0.060 | 1.0 |
| | | 3.075 | 0.020 | 0.7 | 0.024 | 0.8 |

* Meq/L is equivalent to mmol/L for Potassium

Validation of precision performance for Glucose and Magnesium on AU5800.

| Measurand | Units | Mean | Within Run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV % | SD | CV % |
| Glucose | mg/dL | 54.5 | 0.3 | 0.5 | 0.5 | 1.0 |
| | | 117.2 | 0.5 | 0.4 | 0.6 | 0.5 |
| | | 297.7 | 1.2 | 0.4 | 2.1 | 0.7 |
| Magnesium | mg/dL | 2.26 | 0.02 | 1.0 | 0.03 | 1.4 |
| | | 2.67 | 0.03 | 1.0 | 0.04 | 1.6 |
| | | 7.62 | 0.12 | 1.6 | 0.16 | 2.1 |

# b. Linearity/assay reportable range:

Linearity studies were carried out following an internal protocol. Samples were prepared by diluting a high serum pool with a low sample pool to obtain 11 concentrations across the measuring range. Linear regression analyses results and claimed reportable ranges are shown below. Results of the study support the sponsor's measuring range claims as established in the predicates (Potassium, k921718; Magnesium, k944407; Glucose, k944406/k924601).

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| Measurand | Slope | Intercept | Sample Range | Claimed Range |
| --- | --- | --- | --- | --- |
| Potassium (cell 1) | 1.000 | 0.007 | 0.18-10.9 mEq/L | 1.0-10.0 mEq/L |
| Potassium (cell 2) | 0.995 | 0.005 | 0.13-10.8 mEq/L | |
| Magnesium | 0.986 | 0.002 | 0.003-9.2 mg/dL | 0.5-8.0 mg/dL |
| Glucose | 1.009 | -1.832 | 7-878 mg/dL | 10-800 mg/dL |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Please refer to k043460.

d. Detection limit:

Limits of Blank (LoB), Limits of Detection (LoD), and Limit of Quantitation were evaluated following CLSI EP17-A guideline.

For LoB determination, saline supplemented with $5\%$ Bovine Serum Albumin was measured in triplicate using 2 lots of reagents on 2 analyzers over 5 days $(N = 60)$ . The LoB is defined as $\mathrm{LoB} = \mathrm{Mean}_{\mathrm{B}} + 1.645 \mathrm{SD}_{\mathrm{B}}$

For LoD/LoQ determination, five low serum samples were prepared using low patient serum samples diluted with the blank (Saline+5% BSA). Each sample is measured in duplicate using 2 lots of reagents on 2 analyzers over 5 days $(N = 40)$ . The LoD is defined as $\mathrm{LoD} = \mathrm{LoB} + (1.645 * \mathrm{STDEV}$ of Low samples). LoQ is defined as the lowest concentration at which $95\%$ CI of the CV is less or equal to the CAP goal of Total Error.

The results are summarized in the below Table:

| Analyte | LoB | LoD | LoQ | CAP TE goal |
| --- | --- | --- | --- | --- |
| Magnesium (mg/dL) | 0.0 | 0.1 | 0.2 | 25% |
| Glucose (mg/dL) | 0.6 | 1.3 | 4.9 | 12% |

See linearity study in section M.1.b of this $510(\mathrm{k})$ decision summary for ISE methods.

e. Analytical specificity:

To validate the analytical specificity of the reagents on AU5800, the sponsor determined the level of interference from the substances normally present in serum. Each of the substances was spiked at different concentrations into pooled patient serum samples with low and high analyte concentrations. The pooled serum samples are altered when necessary to give rise to the desired analyte concentration.

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The sponsor defines no significant interference as $&lt; 10\%$ difference between the spiked and the control samples. The interference substances examined and their concentrations tested are listed in the following table:

| Reagent & Application | Measurand Levels | Interferent | Interferent level | Specification |
| --- | --- | --- | --- | --- |
| Glucose OSR6x21 | 73 mg/dL117 mg/dL | Lipemia* | 700 mg/dL | <10% |
| | 83 mg/dL112 mg/dL | Bilirubin | 40 mg/dL | <10% |
| | 74 mg/dL115 mg/dL | Hemolysis | 500 mg/dL | <10% |
| Magnesium OSR6x89 | 4.02 mg/dL6.46 mg/dL | Lipemia* | 500 mg/dL | <10% |
| | 4.11 mg/dL6.53 mg/dL | Bilirubin | 36 mg/dL | <10% |
| | 4.08 mg/dL6.50 mg/dL | Hemolysis | 150 mg/dL | <10% |
| | 5.97 mg/dL3.63 mg/dL | Calcium | 30 mg/dL | <10% |

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

For Potassium there are no specific interference claims. The sponsor declares in the labeling that "Separate serum from blood cells as soon as possible. Avoid hemolysis since it can lead to falsely elevated $\mathrm{K}^+$ values." "Certain anticoagulants, preservatives, drugs, and organophilic compounds may affect electrolyte determinations. For further information on interfering substances, refer to Young for a compilation of reported interferences with this test. Visually turbid urine specimens should be centrifuged prior to analysis. Grossly lipemic samples may show an inappropriate decrease in, potassium, and results due to volume displacement. Such samples should be ultracentrifuged and the analysis performed on the infranatant (middle clear layer)."

# f. Assay cut-off:

Not applicable.

# 2. Comparison studies:

# a. Method comparison with predicate device:

Unscreened patient serum samples were used in the method comparison studies. When necessary, samples were spiked or diluted to cover the entire measuring range. For Magnesium, 109 patient samples were studied with $3.7\%$ of the samples altered. For Glucose, 173 patient samples were studied with $18\%$ of the

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samples altered. For Potassium, 200 patient samples were studied with 26% of the samples altered.

The summary of method comparison data for Potassium (AU5800 vs. AU680 analyzers), Glucose (AU5800 vs. AU2700), and Magnesium (AU5800 vs. AU2700) are presented in the below table.

| Reagent & Sample type | Units | Sample Range | N | R | Slope | Intercept |
| --- | --- | --- | --- | --- | --- | --- |
| Potassium | mEq/L* | 1.99 to 9.93 | 199 | 0.9995 | 0.990 | 0.075 |
| Glucose | mg/dL | 22.3 to 784.6 | 173 | 0.9998 | 0.993 | -1.6 |
| Magnesium | mg/dL | 0.5 to 7.2 | 109 | 0.9985 | 1.034 | 0.0 |

* Meq/L is equivalent to mmol/L for Potassium

b. Matrix comparison:

Serum is the only matrix tested in this submission.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The sponsor performed studies to verify the reference ranges (listed below) of the following analytes following CLSI C28-A3 guidelines. 20 serum samples were collected from apparently healthy volunteers and tested. The sponsor's acceptance criteria were that no more than 2 (10%) of the test results should fall outside the ranges referenced. The sponsor's test results passed the acceptance criteria.

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Serum K⁺, 3.5 - 5.1 mEq/L

Tietz, N.W., editor, Fundamentals of Clinical Chemistry, 3rd Edition, W.B. Saunders 1987.

Serum Glucose, 70 - 105 mg/dL

Bondar, R.J.L. and Mead, D.C., Clin Chem, 20: 586, 1974.

Serum Magnesium, 1.9 - 2.7 mg/dL

Beckman Coulter Inc. data on samples collected from 200 blood donors in North Texas.

Beckman recommend in the labeling that “Expected values may vary with age, sex, diet and geographical location. Each laboratory should determine its own expected values as dictated by good laboratory practice.”

N. Instrument Name:

Beckman Coulter AU5800 Clinical Chemistry Analyzer

O. System Descriptions:

1. Modes of Operation:

Fully automated, random access, routine and STAT modes.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ x ☐ or No ☐

3. Specimen Identification:

Bar code

4. Specimen Sampling and Handling:

Instruction on sample handling is provided in the reagent labeling.

5. Calibration:

Calibration stability for each measurand is indicated in the reagent labeling.

6. Quality Control:

Beckman Coulter recommends that during operation of the AU analyzer, at least two

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levels of an appropriate quality control material should be tested a minimum of once a day. In addition, controls should be performed after calibration, with each new lot of reagent, and after specific maintenance or troubleshooting steps described in the appropriate User's Guide. Quality control testing should be performed in accordance with regulatory requirements and each laboratory's standard procedure.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

None

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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