BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

K160370 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · JGS · Jun 9, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160370
• Device Name: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+(sodium), K+(potassium), Cl- (chloride) in serum, plasma and urine samples, and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. The BS-800M/ABS800/BA-800M ISE Kit is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum, plasma and urine samples on the The BS-800M/ABS800/BA-800M Chemistry Analyzer. Sodium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by, low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney function and other diseases associated with protein catabolism.

Device Story

Automated clinical chemistry analyzer; performs in vitro photometric assays and ion-selective electrode (ISE) measurements. Inputs: serum, plasma, or urine samples. Photometric unit uses tungsten halogen lamp, diffraction grating spectrophotometer, and photodiode detector to measure absorbance; ISE module uses ion-selective electrodes for electrolyte concentration. System is computer-controlled; features rack feeder, reagent/sample disks, and positive displacement pipettor. Used in clinical laboratories by trained personnel. Output: quantitative concentration results for Na+, K+, Cl-, and BUN. Results integrated into LIS; used by clinicians to monitor electrolyte balance, diagnose metabolic disorders, and assess organ function. Benefits: high-throughput automated testing, improved diagnostic efficiency.

Clinical Evidence

Bench testing only. Performance validated via precision (repeatability/total precision), linearity, limit of detection (LoB/LoD/LoQ), and analytical specificity (interference studies). Method comparison against predicate (N=120-124 per analyte) showed high correlation (r > 0.99). Matrix comparison (serum vs. lithium heparin plasma) confirmed equivalency.

Technological Characteristics

Automated chemistry analyzer; photometric and ISE sensing principles. Photometric unit: tungsten halogen lamp, diffraction grating, photodiode detector. ISE module: Na+, K+, Cl-, and reference electrodes. Throughput: 800 photometric tests/hr, 1200 tests/hr with ISE. Reaction unit: 165 glass non-disposable cuvettes, 37°C. Connectivity: barcode identification. Power: 110/115V. Operating environment: 15-30°C, 35-85% humidity.

Indications for Use

Indicated for clinical laboratory use for quantitative measurement of Na+, K+, Cl- in serum, plasma, and urine, and Urea Nitrogen in serum. Used to monitor electrolyte balance, diagnose/treat electrolyte/metabolic disorders, and assess liver/kidney function.

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

• BS-200 Chemistry Analyzer with ISE Module (k072018)
• Pointe Scientific BUN (Liquid) Reagent Set (k972671)

Submission Summary (Full Text)

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

A. 510(k) Number:
k160370

B. Purpose for Submission:
Adding a previously cleared assay (BUN-k972671) on a new instrument, and clearance of a new ISE kit

C. Measurand:
Sodium, Potassium, Chloride and Urea Nitrogen

D. Type of Test:
Quantitative, Photometric and Ion Selective Electrodes

E. Applicant:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd

F. Proprietary and Established Names:
BS-800M Chemistry Analyzer
BA-800M Chemistry Analyzer
ABS-800 Chemistry Analyzer
BS-800M/ ABS800/BA-800M ISE Kit

G. Regulatory Information:

| Product Code | Regulation Name | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| CGZ | Chloride test system | II | 21CFR 862.1170 | Chemistry (75) |
| CEM | Potassium test system | II | 21CFR 862.1600 | Chemistry (75) |
| JGS | Sodium test system | II | 21CFR 862.1665 | Chemistry (75) |
| CDQ | Urea nitrogen test system | II | 21CFR 862.1770 | Chemistry (75) |
| JJE | Discrete Photometric Chemistry Analyzer for Clinical Use | I, exempt | 21CFR 862.2160 | Chemistry (75) |

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H. Intended Use:

1. Intended use(s):

See indications for use

2. Indication(s) for use:

The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples, and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

The BS-800M/ABS800/BA-800M ISE Kit is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum, plasma and urine samples on the BS-800M/ABS800/BA-800M Chemistry Analyzer.

Sodium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by, low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney function and other diseases associated with protein catabolism.

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

BS-800M/BA-800-M/ABS8000 Chemistry Analyzer

These three analyzers are different models of the same chemistry analyzer and they only differ in appearance and logo on the instruments. The BS-800M Chemistry Analyzer is selected to represent the three analyzers in this 510(k) submission.

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I. Device Description:

The BS-800M/BA-800M/ABS800 Chemistry Analyzers are automated clinical chemistry analyzers utilizing photometric and ion selective electrode technology for clinical use. The Urea Nitrogen (BUN) (previously cleared in k972671) is chosen to demonstrate performance of the photometric unit. The ISE unit measures sodium, potassium and chloride utilizing ion selective electrode technology, and consists of the following:

1. BUN reagent contains the following:
- Working reagent concentrations: Urease (Jack Bean) 15,000 U/L GLDH (Bovine) > 200 U/L, ADP > 0.6 mM, α-Ketoglutarate 3.6 mM, NADH > 0.28 mM, Buffer, pH 7.8 + 0.1, Sodium Azide (0.25%) as preservative.

2. ISE module contains the ion-selective electrodes for sodium, potassium, chloride and a reference electrode, plus the following reagents:
- MR serum standard - Components: Sodium Chloride (120 and 160 mmol/L), Potassium Chloride (3.5 and 6.0 mmol/L), Deionized Water, Surfactant and Preservatives.
- MR urine standard - Components: Sodium Chloride (50 and 200 mmol/L), Potassium Chloride (10 and 100 mmol/L), Deionized Water, Surfactant and Preservatives.
- MR Buffer Solutions - Components: Formaldehyde: < 1.0 w/v% and Phosphoric acid: < 1.0 w/v%.
- MR Na/K Check Solution- Components: Sodium Chloride, Potassium Chloride, Deionized Water, Surfactant and Preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s):
BS-200 Chemistry Analyzer with ISE Module
Pointe Scientific BUN (Liquid) Reagent Set

2. Predicate 510(k) number(s):
k072018
k972671

3. Comparison with predicate:

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1. Comparison of BS-800M with ISE module and BS-200 with ISE module

| Item | Candidate Device:BS-800M Chemistry Analyzer with ISE | Predicate Device: BS-200 Chemistry Analyzer with ISE k072018 |
| --- | --- | --- |
| Intended Use | | |
| Intended use | The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. | Same |
| System Function | | |
| Method | Ion Selective Electrode | Same |
| Electrode | Na+ electrode, K+ electrode, Cl- electrode, reference electrode | Na+ electrode, K+ electrode, Cl- electrode, reference electrode, Space electrode |
| Reference reagent | MR Serum Standard, MR Urine Standard, MR Buffer Solution, MR Detergent Solution, MR Na/K Check Solution | Reagent Pack, Urine Diluent, Cleaning Solution |
| ISE Internal Standard | None | Same |
| Sample Volume | 22 μL total for all three tests | 70 μL Serum, plasma mode; 140 μL Urine mode |
| ISE Throughput Rate | 600 tests/hour | 300 tests/hour Serum, plasma mode; 198 tests/hour Urine mode |
| Test Environment | Clinical Lab | Same |
| Calibration | | |
| Calibrator | MR Serum Standard for Serum, Plasma mode; MR Urine standard for Urine mode | ISE reagent pack for all three sample types |

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| Standardization | Na: NIST standard material SRM 919
K: NIST standard material SRM 918
Cl: NIST standard material SRM 919 | Na: NIST standard material SRM 956
K: NIST standard material SRM 956
Cl: NIST standard material SRM 956 |
| --- | --- | --- |
| Calibrator Stability | 5°C~35°C, 12 months of shelf-life, 8 weeks of in-use stability | 4°C~25°C, 24 months of shelf-life |
| Calibrator Matrix | Buffered Aqueous matrix | Same |
| Calibrator Form | liquid | Same |
| Number of Calibrator levels | Two for serum/Plasma and Two for Urine | Same |
| Calibration Frequency | Daily | 8 hours |
| Performance Characters | | |
| Analytical Measuring (mmol/L) | Serum/Plasma
Na: 100-200, K: 1-8, Cl: 50-150
Urine
Na: 10-400,K: 5-200, Cl: 15-400 | Serum/Plasma
Na: 113-194, K: 1.1-8.6, Cl: 53-154
Urine
Na: 27-372, K: 13-184, Cl: 42-422 |
| Reference Interval | Serum(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.5-5.1 mmol/L
Chloride: 98-107 mmol/L
Plasma(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.4-4.5 mmol/L
Chloride: 98-107 mmol/L Urine, 24 hour (Adults): Sodium: 40-220 mmol/24h Potassium:25-125 mol/24h, Chloride:110-250 mol/24h | Serum(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.5-5.1 mmol/L
Chloride: 98-107 mmol/L
Plasma(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.4-4.5 mmol/L
Chloride: 98-107 mmol/L Urine, 24 hour (Adults): Sodium: 40-220 mmol/24h Potassium:25-125 mol/24h
Chloride:110-250 mol/24h |

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| NSI Interferences concentration | Bilirubin- Na/K/Cl for three sample types: 40 mg/dL
Hemoglobin- Na/Cl for three sample types: 500 mg/dL, Urine K: 500 mg/dL
Lipemia- Na/K/Cl for three sample types: 1000 mg/dL
Ascorbic acid- Na/K/Cl for three sample types: 30 mg/dL | Bilirubin -Na/K/Cl for three sample types: 20 mg/dL
Hemoglobin- Na/K/Cl for three sample types: 500 mg/dL
Lipemia- Na/K/Cl for three sample types: 1000 mg/dL |
| --- | --- | --- |
| Throughput (Max) of the analyzer functionality comparisons: | | |
| | 800 photometric tests per hour 1200 tests per hour with ISE | 200 photometric tests per hour 330 tests per hour with ISE |
| Configuration | | |
| | Analyzing unit, the Rack Feeder System, Operation unit, Output unit | Analytical unit, Operation unit, Output unit |
| Principle of Analysis | | |
| Mode of detection | Photometric | Same |
| Analytical methods | Endpoint
Fixed-time | Same |
| Calibration methods | Linear calibration and nonlinear calibration | Same |
| Optical Measurement Unit | | |
| Measurement Modes | Absorbance | Same |
| Optical Modes | Monochromatic, bichromatic | Same |
| Photometer | Multi-wavelength, diffraction grating spectrophotometer | Multi-wavelength, Light transmission mode of the Filter |
| Wavelength | 340nm, 380nm, 412nm, 450nm, 505nm, 546nm, 570nm, 605nm, 660nm, | 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm |
| Linear absorbance | 0-3.4 absorbance | 0-4.0 absorbance |
| Light Source | Tungsten halogen lamp | Same |

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| Detector | Photodiode | Same |
| --- | --- | --- |
| Reaction Unit | | |
| Reaction cuvettes | Glass, 165 non-disposable | Plastic, 80 disposable |
| Reaction volume | 100~360μL | 180~500μL |
| Optical path | 5mm | Same |
| Reaction | 37°C | Same |
| Sample and Reagent System | | |
| Sample disk | 140 positions. 45 positions respectively for outer two circles of outer rings and 25 positions respectively for inter two circles of | 40 sample tube positions on the outer circle |
| Reagent disk | 120 positions. 50 positions for inner circle and 70 positions for outer circle. | 40 reagent bottle positions on the inner circle |
| Pipettor System | Positive displacement stepper motor driven | Same |
| Refrigerator | 2-8°C | 4-15°C |
| Sample Dispense | 1.5μL -50μL | 3μL -45μL |
| Reagent Dispense | 15μL-300μL | 30μL-450μL |
| Power | | |
| Input | 110/115V~±10%, 60Hz±1 Hz | 100-130V~,50/60±1 Hz |
| Consumption | 3800VA | 1000 VA |
| Operating environmental conditions | | |
| Temperature | 15°C to 30°C | Same |
| Humidity | 35% to 85%, non-condensing | Same |

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2. Comparison of the BUN test system:

| Similarities and difference | | |
| --- | --- | --- |
| Item | Candidate Device of clearance of the Pointe Scientific BUN reagent | Predicate Device: Pointe Scientific BUN reagent k972671 |
| Intended Use | For the quantitative in vitro determination of BUN in serum. | Same |
| Assay Method | Urease method | Same |
| Chemistry analyzer used | BS-800M/BA-800M/ABS800 Chemistry analyzers | ACE Schiapparelli chemistry analyzer |
| Sample Type | Serum | Same |

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

CLSI-EP5-A3. Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline- Third Edition.

CLSI-EP6-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

CLSI-EP9-A3. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline- third Edition.

CLSI- EP7-A2. Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition.

CLSI- EP17-A2. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second edition.

L. Test Principle:

BUN-Urea is hydrolyzed by urease to produce ammonia and carbon dioxide. The liberated ammonia reacts with $\alpha$-ketoglutarate in the presence of NADH to yield glutamate. An equimolar quantity of NADH undergoes oxidation during the reaction resulting in a decrease in absorbance that is directly proportional to the urea nitrogen concentration in the sample.

ISE- The ion selective electrodes develop a voltage that varies with the concentration of the ion to which it responds, through the contact with samples. The relationship between the voltage developed and the concentration of the sensed ion is logarithmic, as expressed by the Nernst equation. Then the concentration of the ion (sodium, potassium, and chloride concentration in serum and plasma samples) can be calculated by the Nernst equation and the parameters obtained from the ISE testing process.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision studied were performed according to CLSI document EP5-A3. Repeatability and total precision of serum BUN, serum Na, K and Cl, and urine Na, K and Cl were demonstrated by analyzing two levels of serum and urine based controls on the BS-800M Chemistry Analyzer. The control pools were analyzed in 20 replicates in one run for each analyte to obtain the within run precision (N=20). Two levels of serum and urine based controls were tested in duplicate twice per day for 20 days to obtain the total precision (N=80). Results are summarized in the tables below:

| Analyte | Sample | Mean (mmol/L) | Repeatability | | Total (Within Device) Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV% | SD | CV% |
| BUN (mg/dL) | Control pool 1 | 11.0 | 0.28 | 2.5% | 0.33 | 3.0% |
| | Control pool 2 | 46.4 | 0.57 | 1.2% | 0.94 | 2.0% |
| Serum Na+ | Control pool 1 | 136.1 | 0.35 | 0.3% | 0.83 | 0.6% |
| | Control pool 2 | 166.1 | 0.46 | 0.3% | 1.12 | 0.7% |
| Serum K+ | Control pool 1 | 3.72 | 0.006 | 0.2% | 0.021 | 0.6% |
| | Control pool 2 | 6.10 | 0.013 | 0.2% | 0.033 | 0.5% |
| Serum Cl- | Control pool 1 | 89.4 | 0.21 | 0.2% | 0.38 | 0.4% |
| | Control pool 2 | 107.5 | 0.23 | 0.2% | 0.44 | 0.4% |
| Urine Na+ | Control pool 1 | 87.1 | 0.22 | 0.3% | 0.44 | 0.5% |
| | Control pool 2 | 148.6 | 0.36 | 0.2% | 0.74 | 0.5% |

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| Analyte | Sample | Mean (mmol/L) | Repeatability | | Total (Within Device) Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV% | SD | CV% |
| Urine K+ | Control pool 1 | 35.1 | 0.08 | 0.2% | 0.21 | 0.6% |
| | Control pool 2 | 68.8 | 0.16 | 0.2% | 0.41 | 0.6% |
| Urine Cl- | Control pool 1 | 90.4 | 0.20 | 0.2% | 0.40 | 0.4% |
| | Control pool 2 | 133.9 | 0.17 | 0.1% | 0.48 | 0.4% |

# b. Linearity/assay reportable range:

The linearity studies were performed followed the CLSI EP06-A guidance. Eleven equally spaced samples covering the measurement range were prepared by mixing high and low concentration samples. Four replicates were measured for each sample. The results are summarized in the table below:

| Analyte | Slope | Intercept | R2 | Linear Range Tested (mg/dL for BUN and mmol/L for ISE) | Claimed Measuring range |
| --- | --- | --- | --- | --- | --- |
| BUN | 0.9999 | 0.0053 | 0.9996 | 4.5-162.6 | 5-150 |
| Serum Na+ | 0.9996 | 0.0783 | 1.0000 | 41.9-224.4 | 100-200 |
| Serum K+ | 0.9997 | -0.0003 | 0.9999 | 0.61-9.34 | 1-8 |
| Serum Cl- | 0.9998 | 0.0389 | 0.9999 | 11.0-162.4 | 50-150 |
| Urine Na+ | 1.0000 | 0.0139 | 0.9999 | 7.5-469.5 | 10-400 |
| Urine K+ | 1.0001 | 0.0175 | 0.9999 | 3.1-254.4 | 5-200 |
| Urine Cl- | 1.0000 | 0.0370 | 0.9999 | 10.9-439.4 | 15-400 |

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

Traceability

Each electrolyte's traceability information is shown below.

| Analyte | Reference methods/materials |
| --- | --- |
| Na | Atomic absorption method (NIST standard material SRM919) |
| K | Atomic absorption method (NIST standard material SRM918) |
| Cl | Atomic absorption method (NIST standard material SRM919) |

Traceability for BUN reagent is to NIST BUN standard and was established under k972671.

Stability

MR Serum/Urine Standards are stable for 12 months when stored at 5°C~35°C and protected from light. Once opened, MR Serum/Urine Standards are stable for 8 weeks when stored tightly capped at 5°C ~35°C and protected from light. The protocols for stability and acceptance criteria were reviewed and found to be adequate. BUN reagent stability was evaluated under k972671. Closed vial stability is at 2-8°C and open vial stability is 3 days at 18-25°C and 14 days at 2-8°C.

Value assignment

The MR Serum Standards (High/Low levels) and MR Urine Standards (High/Low levels) consist of Sodium Chloride, Potassium Chloride, Deionized Water, Surfactant and Preservatives. The calibrator values are assigned internally following a traceability process based on EN ISO 17511.

The target values are shown in the tables below:

| MR Serum Standards | Na⁺ | K⁺ | Cl⁻ |
| --- | --- | --- | --- |
| High level (mmol/L) | 160 | 6.0 | 120 |
| Low level (mmol/L) | 120 | 3.5 | 85 |
| MR Urine Standards | Na⁺ | K⁺ | Cl⁻ |
| High level (mmol/L) | 200 | 100 | 180 |
| Low level (mmol/L) | 50 | 10 | 50 |

The value assignment procedures for calibrators and controls of BUN Test System have been previously evaluated under k070207 and k042318.

d. Detection limit:

The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) were evaluated in accordance with CLSI EP17-A2 Guideline using the BS-

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800M Chemistry Analyzer.

LoB was determined by testing five blank samples using two reagent lots over three days. Every sample was assayed in four replicates per reagent lot per day. A total of 60 measurements were obtained per reagent lot.

LoD was determined by testing five low level samples using two reagent lots over three days. In total 60 measurements were obtained per reagent lot.

In the LoQ studies, five low level samples of known measurand concentration are prepared. The BUN and serum Na+, K+ and Cl- concentration is obtained from dilution calculation with SRM 956d and SRM 909c whose measurand concentration is determined by NIST. And urine Na+, K+ and Cl- concentration is obtained from dilution calculation with salt solution whose measurand concentration is determined by theoretical spike. All samples were assayed in four replicates per reagent lot per day for three days.

Results are summarized in the table below.

| Analyte | Unit | LoB | LoD | LoQ | Claimed Measurement Range |
| --- | --- | --- | --- | --- | --- |
| BUN | mg/dL | 0.4 | 0.9 | 4.2 | 5-150 |
| Serum Na+ | mmol/L | 1.9 | 3.5 | 39.5 | 100-200 |
| Serum K+ | mmol/L | 0.04 | 0.05 | 0.54 | 1-8 |
| Serum Cl- | mmol/L | 0.5 | 0.6 | 9.5 | 50-150 |
| Urine Na+ | mmol/L | 0.9 | 1.4 | 6.9 | 10-400 |
| Urine K+ | mmol/L | 0.1 | 0.2 | 2.4 | 5-200 |
| Urine Cl- | mmol/L | 0.2 | 0.3 | 9.8 | 15-400 |

e. Analytical specificity:

Interference studies are carried out according to the CLSI EP7-A2 guideline.

Interference studies were performed to determine the effects from potential interferents such as bilirubin, hemoglobin, lipemia, ascorbic acid, drugs on the BUN and the ISE assays using the BS-800M Chemistry Analyzer. Multiple levels of interference were tested for each analyte. The sponsor states that interference is considered to be non-significant if the bias between the tested and control samples are within +/-10%. The highest endogenous substance concentration tested that shows non-significant interference are summarized below:

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| Item | Highest Concentration Tested that showed no significant interference | | | |
| --- | --- | --- | --- | --- |
| | Total Bilirubin (mg/dL) | Hemoglobin (mg/dL) | Lipemia (mg/dL) | Ascorbic Acid (mg/dL) |
| Serum BUN | 40 | 500 | 750 | 30 |
| Serum Na+ | 40 | 500 | 1000 | 30 |
| Serum K+ | 40 | * | 1000 | 30 |
| Serum Cl- | 40 | 500 | 1000 | 30 |
| Urine Na+ | 40 | 500 | 1000 | 30 |
| Urine K+ | 40 | 500 | 1000 | 30 |
| Urine Cl- | 40 | 500 | 1000 | 30 |

* Hemolysis can lead to falsely elevated K+ values.

The highest exogenous substance concentration tested that shows non-significant interference are summarized below.

| Drug Interferents | Drug Level tested(mg/dL) |
| --- | --- |
| Imipramine | 0.15 |
| Procainamide | 15 |
| Nortriptyline | 0.26 |
| Hydroxytyramine | 50.7 |
| Ibuprofen | 512 |
| Valproic acid | 75 |
| Chlorpromazine | 6 |
| Salicylic acid | 72 |
| Acetylsalicylic acid | 1205 |
| Erythromycin | 7.6 |
| Ethosuximide | 30.6 |
| Acetaminophen | 242 |
| Benzalkonium Chloride | 10.4 |
| Ampicillin | 6 |

There was significant interference from Hemoglobin and Potassium thiocyanate. The sponsor added the following limitations to their labeling:

- Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium. Intracellular potassium concentration is 30-50 fold greater than that of extracellular serum or plasma.
- Potassium thiocyanate increases potassium by $0.55 \mathrm{mmol} / \mathrm{L}$ at the concentration of $3.30 \mathrm{mmol} / \mathrm{L}$ and by $0.58 \mathrm{mmol} / \mathrm{L}$ at the concentration of $5.39 \mathrm{mmol} / \mathrm{L}$ .
- Potassium thiocyanate increases chloride by $12.3\mathrm{mmol / L}$ at the concentration of $90.9\mathrm{mmol / L}$ and by $12.6\mathrm{mmol / L}$ at the concentration of $114.6\mathrm{mmol / L}$

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f. Assay cut-off:

Not applicable

# 2. Comparison studies:

# a. Method comparison with predicate device:

Method comparison studies were performed according to CLSI document EP9-A3. 120- 124 samples for each analyte were assayed in duplicate on the BS-800M Chemistry Analyzer and the BS-200 Chemistry Analyzer (predicate device). Less than $10\%$ of the samples were spiked or diluted to fully span the claimed measuring range of each analyte. The first of the duplicate results from the BS-800 chemistry analyzer were compared against the predicate's results. The Deming regression analysis results are shown in the table below.

| Analyte | Sample Range Tested (mmol/L) | Claimed Linear Range | N | Slope | Intercept | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- | --- |
| Serum BUN | 5.4-149.5 (mg/dL) | 5-150 | 122 | 0.98 | 0.81 | 0.9997 |
| Serum Na+ | 100.2-196.4 | 100-200 | 124 | 1.03 | -5.95 | 0.9966 |
| Serum K+ | 1.40-7.70 | 1-8 | 121 | 1.04 | -0.09 | 0.9994 |
| Serum Cl- | 50.4-149.4 | 50-150 | 124 | 1.00 | 0.15 | 0.9993 |
| Urine Na+ | 12.1-395.4 | 10-400 | 120 | 0.99 | -2.52 | 0.9997 |
| Urine K+ | 5.1-194.7 | 2-200 | 120 | 0.98 | -1.00 | 0.9997 |
| Urine Cl- | 15.2-381.3 | 15-400 | 120 | 0.97 | 2.06 | 0.9988 |

# b. Matrix comparison:

Serum and lithium heparin plasma equivalency was demonstrated for the Sodium, Potassium and Chloride assays on the BS-800M Chemistry Analyzer by testing 51 matched samples. Less than $10\%$ of total samples were samples diluted with water or spiked with NaCl or KCl to span the assay ranges. One replicate of each sample was collected and used for the analyses. The table below summarizes the Deming linear regression results statistics when comparing lithium heparin plasma sample results to serum sample results:

| Analyte | Unit | N | Sample Range | Slope | Intercept | Correlation Coefficient |
| --- | --- | --- | --- | --- | --- | --- |
| Na+ | mmol/L | 51 | 105.2-195.9 | 1.000 | -0.33 | 0.9989 |
| K+ | mmol/L | 51 | 1.45-7.87 | 0.966 | -0.13 | 0.9930 |
| Cl- | mmol/L | 51 | 54.2-148.1 | 0.996 | 0.62 | 0.9997 |

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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 range¹:

| | Serum | Plasma | Urine (24 hour) |
| --- | --- | --- | --- |
| BUN | 6 - 20 mg/L | -- | -- |
| Sodium | 136-145 mmol/L | 135-145 mmol/L | 40-220 mmol/L |
| Potassium | 3.5 – 5.0 mmol/L | 3.5-4.5 mmol/L | 25-125 mmol/L |
| Chloride | 98-107 mmol/L | 100-108 mmol/L | 110-250 mmol/L |

¹Tietz NW, editor: Fundamentals of clinical chemistry, 6th Edition, W.B. Saunders Co., Philadelphia, PA, 2008

N. Instrument Name:

BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

These three analyzers are different models of the same chemistry analyzers and they only differ in appearance and logo on the instruments. The BS-800M Chemistry Analyzer is selected to represent the three analyzers in this 510(k) submission.

O. System Descriptions:

1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

{15}

Yes _______ or No ☐

2. Software: FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes ☑ or No ☐

3. Specimen Identification:

Barcode identification is available for specimen tubes and reagent bottles.

4. Specimen Sampling and Handling:

The system supports manual and auto load of samples. The analyzing unit handles all analyzing operations, which include sample and reagent handling, mixing, reaction, measurements, cuvette wash station.

5. Calibration:

The sponsor recommends BUN calibration frequency every 14 days or with change in reagent lot or as indicated by quality control procedures. This product has been previously cleared in k070207. The sponsor recommends user to perform an ISE Two-point calibration using fixed concentrations of MR Urine Standard and MR Serum Standard for the ISE module on BS-800M, ABS800, BA-800M Chemistry Analyzer.

6. Quality Control:

The analyzer has a built in quality control program with two mode to run control samples, automatic or manual. The labeling recommends running control samples every time after the user performs a calibration, or change the reagent lot, or maintain and troubleshoot the instrument.

The sponsor recommends in their labeling that QC materials should be run after each calibration of the ISE module. Controls should be run once each day of use. It is recommended that each laboratory establish their own frequency of control determination.

P. Proposed Labeling:

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

Q. Conclusion:

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