BS-200 CHEMISTRY ANALYZER, MODE BS-200

K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CFR · Feb 1, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072018
• Device Name: BS-200 CHEMISTRY ANALYZER, MODE BS-200
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. 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.

Device Story

BS-200 Chemistry Analyzer is an automated in vitro diagnostic device for clinical laboratories. It processes serum, plasma, urine, or CSF samples. The device utilizes absorbance photometry for general chemistry assays and an optional Ion-Selective Electrode (ISE) module for electrolyte (Na+, K+, Cl-) measurement. Samples are analyzed using reagent-induced photometric reactions or ISE technology; concentrations are determined via standard curves generated from known calibrators. The system is operated by laboratory personnel. Output consists of quantitative analyte concentrations, which clinicians use to diagnose and monitor electrolyte imbalances and metabolic disorders, including diabetes and hypoglycemia. The device automates sample analysis to provide rapid, accurate diagnostic data for patient management.

Clinical Evidence

Bench testing only. Performance validated via precision studies (20-day, CLSI EP5-A2), linearity studies (CLSI EP6-A), and method comparison studies against predicate devices (Hitachi 917 and EasyElectrolytes). Glucose method comparison (N=60) showed r=0.9992. ISE serum/urine method comparisons (N=40 each) showed high correlation (r=0.9868–0.9992). Interference testing performed for bilirubin, hemoglobin, and intralipid.

Technological Characteristics

Automated discrete chemistry analyzer. Photometric module (tungsten halogen lamp, photodiode detector) and ISE module. Analytical methods: endpoint, fixed-time, kinetic. Calibration: linear and nonlinear. Connectivity: LIS external capability, barcode reader. Power: 100-130V. Software: microprocessor-controlled. Standards: IEC 61010-1, ISO 14971, CLSI EP05-A2, EP06-A, EP07-A2, EP09-A2, EP17-A.

Indications for Use

Indicated for clinical laboratory use to perform direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl- (chloride) in serum, plasma, and urine, and Glucose in serum. Used for diagnosis and treatment of electrolyte imbalance, metabolic disorders, and carbohydrate metabolism disorders (e.g., diabetes mellitus, hypoglycemia, pancreatic islet cell carcinoma).

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Roche, Hitachi 911 analyzer (k953239)
• Point Scientific Glucose reagent (k002199)
• Medica Easyelectrolyte Analyzer and Rapidlyte Analyzer (k000926)

Submission Summary (Full Text)

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

A. 510(k) Number:
k072018

B. Purpose for Submission:
New submission for glucose, sodium, potassium and chloride on a new analyzer

C. Measurand:
Glucose, Sodium, Potassium, Chloride

D. Type of Test:
Quantitative photometric and Ion Selective Electrode

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

F. Proprietary and Established Names:
BS-200 Chemistry Analyzer, Mode BS-200

G. Regulatory Information:

1. Regulation section:
21CFR Sec.-862.1345 Glucose test system.
21CFR Sec.-862.1665 Sodium test system.
21CFR Sec.-862.1600 Potassium test system.
21CFR Sec.-862.1170 Chloride test system.
21CFR Sec.-862.2160-Discrete photometric chemistry analyzer for clinical use.

2. Classification:
Class II for assays
Class I for analyzer (reviewed as part of Class II test systems)

3. Product code:
CFR - hexokinase, glucose
JGS - electrode, ion specific, sodium
CEM - electrode, ion specific, potassium
CGZ - electrode, ion-specific, chloride
JJE - analyzer, chemistry (photometric, discrete), for clinical use

4. Panel:
Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indications for use below

2. Indication(s) for use:
The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of $\mathrm{Na}^{+}$ (sodium), $\mathrm{K}^{+}$ (potassium), Cl$^{-}$ (chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and

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treatment of diseases conditions characterized by low or high blood potassium levels.

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

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.

3. Special conditions for use statement(s):

Prescription use

4. Special instrument requirements:

BS-200 Chemistry Analyzer

I. Device Description:

The BS-200 is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories and designed for in vitro quantitative determination of clinical chemistries in serum, plasma and urine samples. The device is composed of a photometric module and an Ion Selective Electrode module.

The Glucose reagent is ready to use and the composition is Liquid Glucose (Hexokinase) Reagent: Hexokinase (yeast) 4000U/L, G6PDH (Leuconostoc mesenteroides) 4000U/L, ATP 6.0mM, NAD 3.0mM, Buffer pH 7.5 ± 0.1, Nonreactive stabilizers, and sodium azide (0.1%) as preservative. The reagent is manufactured by Point Scientific for Shenzhen Mindray Bio-Medical.

The ISE module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents. The module is manufactured for Midray by Medica. The electrodes and accessory reagents were also previously cleared as the Medica Easyelectrolyte Analyzer and Rapidlyte Analyzer (k000926).

J. Substantial Equivalence Information:

1. Predicate device name(s):

Roche, Hitachi 911 analyzer

Point Scientific Glucose reagent

Medica Easyelectrolyte Analyzer and Rapidlyte Analyzer

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

k953239

k002199

3. k000926

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Comparison with predicate:

| Comparison Section | BS-200 | Boehringer Mannheim/Hitachi 917 analyzer | EasyElectroLyte/RapidLyte Na/K/Cl Analyzer |
| --- | --- | --- | --- |
| 510(K) Number | Pending | k953239 | k000926 |
| Intended use | The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. | The Boehringer Mannheim/Hitachi 917 analyzer is intended for the quantitative and qualitative measurement of analytes in body fluids. | EasyElectroLyte/Rapid Lyte Na/K/Cl Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Na+ (sodium), K+ (potassium), and Cl- (chloride) found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient. |
| Parameter | Glucose | Glucose | None |
| | ISE (K,Na,Cl) | ISE (K,Na,Cl) | ISE (K,Na,Cl) |

BS-200 and (Roche) Boehringer Mannheim/Hitachi 917 analyzer

| | Feature | BS-200 | Boehringer Mannheim/Hitachi 917 analyzer | S/D |
| --- | --- | --- | --- | --- |
| | 510(K) | Pending | 510(k) Number k953239 | / |
| 1 | Standards | | | |
| | | IEC 61010-1 | IEC 61010-1 | S |
| 2 | System Function | | | |
| | System Control | Automatic, microprocessor controlled | Automatic, microprocessor controlled | S |
| | LIS external connectivity capability | Yes | Yes | S |
| | Calibration/QC | Automatic and Manual calibration/QC | Automatic and Manual calibration/QC | S |
| | Barcode | Yes | Yes | S |
| 3 | Throughput (Max) | | | |
| | | 200 photometric tests per hour 330 tests per hour with ISE | 800 photometric tests per hour 1200 tests per hour with ISE | D |

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| | Feature | BS-200 | Boehringer Mannheim/Hitachi 917 analyzer | S/D |
| --- | --- | --- | --- | --- |
| | 510(K) | Pending | 510(k) Number k953239 | / |
| 4 | Configuration | | | |
| | | Analytical unit, Operational Unit | Analytical unit, Operational Unit | S |
| 5 | Principle of Analysis | | | |
| | Mode of detection | Photometric | Photometric | S |
| | Analytical methods | Endpoint with sample blanking
Fixed-time
Kinetic | Endpoint with sample blanking
Endpoint
Kinetics | S |
| | Calibration methods | Linear calibration and nonlinear calibration | Linear calibration and nonlinear calibration | S |
| 6 | Optical Measurement Unit | | | |
| | Measurement Modes | Absorbance | Absorbance | S |
| | Optical Modes | Monochromatic, Bichromatic | Monochromatic, Bichromatic | S |
| | Wavelength | 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm | 340nm, 376 nm, 415 nm, 450 nm, 505 nm, 546 nm, 570 nm, 600 nm, 660 nm, 700 nm, 800 nm | D |
| | Linear absorbance range | 0.0000-4.0000 absorbance | 0.0000-2.5000 absorbance | D |
| | Light Source | Tungsten halogen lamp | Tungsten halogen lamp | S |
| | Detector | Photodiode | Photodiode | S |
| 7 | Reaction Unit | | | |
| | Reaction cuvettes | Plastics, 80 disposable | Plastics, 160 semi-disposable | D |
| | Reaction volume | 180~500uL | 180~380uL | D |
| | Path length | 5mm | 5mm | S |
| | Reaction temperature | 37°C | 37°C | S |
| 8 | Sample and Reagent System | | | |
| | Sample tube/ reagent bottle positions | 40 sample tube positions on the outer circle and 40 reagent bottle positions on the inner circle | 110 positions on sample disk 1, 60 positions on sample disk 2; 45 positions on reagent disk 1(R1), 44 positions on reagent disk 2(R2) | D |
| | Pipettor System | Positive displacement stepper motor driven | Positive displacement stepper motor driven | S |
| | Refrigerator temperature | 4-15°C | 2-12°C | D |
| | Sample Dispense | 3μl -45μl | 2-35μl | D |
| | Reagent Dispense | 30μl-450μl | 20-270μl | D |
| 9 | POWER | | | |
| | Input | 100-130V~,50/60±1 Hz | 115V±10v AC, 60±0.5 Hz | D |
| | Consumption | 1000 VA (max.) | 3kVA | D |
| 10 | Operating environmental conditions | | | |
| | Temperature | +15°C to +30°C | +15°C to +32°C | D |
| | Humidity | 35% to 80%, non-condensing | 45% to 85% relative humidity | D |

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BS-200 and Easy Electrolytes

| | Feature | BS-200 | EasyElectroLyte/RapidLyte Na/K/Cl Analyzer | S/D |
| --- | --- | --- | --- | --- |
| | 510(K) | Pending | 510(k) Number K000926 | / |
| 1 | Principle | | | |
| | | ISE (ion selective electrode technology) | ISE (ion selective electrode technology) | S |
| 2 | Sample Type | | | |
| | | Serum, plasma, or diluted urine | Serum, plasma, or diluted urine | S |
| 3 | Test | | | |
| | | Na⁺, K⁺, Cl⁻ | Na⁺, K⁺, Cl⁻ | S |
| 4 | Sample Size | | | |
| | | 70 μL Serum, plasma mode; 140 μL Urine mode | 55 μL Serum, plasma mode; 300 μL Urine mode | D |
| 5 | ISE Calibration | | | |
| | | Two-point and single-point calibrations | Two-point and single-point calibrations | S |

K. Standard/Guidance Document Referenced (if applicable):
- IEC 61010-1 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1
- ISO14971 - Medical devices — Application of risk management to medical devices
- CLSI - Evaluation of Precision Performance of Clinical Chemistry Devices - EP05-A2
- CLSI - Evaluation of the Linearity of Quantitative Analytical Methods - EP06-A
- CLSI - Interference Testing in Clinical Chemistry - EP07-A2
- CLSI - Method Comparison and Bias Estimation Using Patient Samples - EP09-A2
- CLSI - Protocols for Determination of Limits of Detection and Limits of Quantitation - EP17-A

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# L. Test Principle:

Glucose

This method uses hexokinase and glucose-6-phosphate-dehydrogenase to catalyze the reaction:

$$
\begin{array}{c c} \text {H K} \\ \text {G l u c o s e + A T P} & \text {G c P + A D P} \\ \text {G 6 P} & \text {G 6 P} \\ \text {G 6 P + N A D} & \text {6 - P h o s p h o g l u c o n a t e + N A D H + H ^ {+}} \end{array}
$$

Glucose is phosphorylated with adenosine triphosphate (ATP) in the reaction catalyzed by hexokinase (HK). The product, glucose-6-phosphate (G6P) is then oxidized with the concomitant reduction of nicotinamide adenine dinucleotide (NAD) to NADH in the reaction catalyzed by glucose-6-phosphate-dehydrogenase (G6PDH). The formation of NADH causes an increase in absorbance at $340\mathrm{nm}$ . The increase is directly proportional to the amount of glucose in the sample.

The ion selective electrodes develop a voltage that varies with the concentration of the ion $(\mathrm{Na}^{+},\mathrm{K}^{+},\mathrm{Cl}^{-})$ to which they are specific. The relationship between the voltage developed and the concentration of the sensed ion is logarithmic and calculated by the Nernst equation.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Glucose

Precision studies were performed using control serum samples at low, middle and high concentration. The studies were conducted for 20 days with two runs per day and duplicates per run according to CLSI EP5-A2 document.

| Within-Run | | | |
| --- | --- | --- | --- |
| Mean | S.D. | C.V.% | N |
| 56 | 0.5 | 0.9 | 80 |
| 122 | 0.7 | 0.6 | 80 |
| 296 | 1.3 | 0.5 | 80 |
| Between-day | | | |
| --- | --- | --- | --- |
| Mean | S.D. | C.V.% | N |
| 56 | 1.1 | 2.0 | 80 |
| 122 | 2.0 | 1.6 | 80 |
| 296 | 4.9 | 1.7 | 80 |

# ISE Serum Mode

Precision studies were performed following a modification of the guidelines contained in CLSI document EP5-A2. The testing was conducted in duplicate for 20 days with two runs per day. The results are summarized in the tables below.

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Within-run precision

| Item | Level I | | | Level II | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean | SD | CV% | Mean | SD | CV% |
| K mmol/L | 4.11 | 0.03 | 0.7% | 6.77 | 0.05 | 0.8% |
| Na mmol/L | 136.13 | 0.61 | 0.4% | 146.74 | 0.72 | 0.5% |
| Cl mmol/L | 99.59 | 0.73 | 0.7% | 115.68 | 0.52 | 0.5% |

Day-to-Day precision

| Item | Level I | | | Level II | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean | SD | CV% | Mean | SD | CV% |
| K mmol/L | 4.11 | 0.07 | 1.6% | 6.77 | 0.06 | 1.0% |
| Na mmol/L | 136.13 | 2.12 | 1.6% | 146.74 | 1.66 | 1.1% |
| CL mmol/L | 99.59 | 1.78 | 1.8% | 115.68 | 1.13 | 1.0% |

ISE Urine Mode
Within-run precision

| Item | Level I | | | Level II | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean | SD | CV% | Mean | SD | CV% |
| K mmol/L | 37.09 | 0.46 | 1.2% | 67.49 | 0.63 | 0.9% |
| Na mmol/L | 99.23 | 1.13 | 1.1% | 170.84 | 1.36 | 0.8% |
| CL mmol/L | 82.90 | 1.36 | 1.6% | 132.16 | 1.24 | 0.9% |

Day-to-Day precision

| Item | Level I | | | Level II | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean | SD | CV% | Mean | SD | CV% |
| K mmol/L | 37.09 | 0.48 | 1.3% | 67.49 | 0.70 | 1.0% |
| Na mmol/L | 99.23 | 1.68 | 1.7% | 170.84 | 2.41 | 1.4% |
| CL mmol/L | 82.90 | 1.50 | 1.8% | 132.16 | 2.12 | 1.6% |

b. Linearity/assay reportable range:
The reportable ranges of the assays are as follows:

Glucose = 1–600 mg/dl

Potassium = 1.1 – 8.6 mmol/L

Sodium = 113 – 194 mmol/L

Chloride = 53 – 154 mmol/L

ISE Urine mode

Potassium = 13 – 184 mmol/L

Sodium = 27 – 372 mmol/L

Chloride = 42 – 442 mmol/L

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Linearity studies were performed to validate the measuring range of the assays. The samples were prepared with 11 concentrations with the range from lowest to the highest concentration. They analyzed each of levels for 4 times, and then calculated the linear deviation and linearity range in accordance with CLSI EP6-A document.

## Glucose Linearity Percent Difference

| Ranks | Assigned (mg/dl) | % of high Std. with saline | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 0 | 0 | 0 | 0.00% |
| 2 | 1 | 0.15% | 1 | 0.00% |
| 3 | 4 | 0.60% | 4 | 0.00% |
| 4 | 17 | 2.50% | 17.25 | 1.47% |
| 5 | 34 | 5% | 34.5 | 1.47% |
| 6 | 68 | 10% | 68.25 | 0.37% |
| 7 | 136 | 20% | 140 | 2.94% |
| 8 | 204 | 30% | 211 | 3.43% |
| 9 | 340 | 50% | 342.5 | 0.74% |
| 10 | 473 | 70% | 479 | 1.27% |
| 11 | 680 | 100% | 686.25 | 0.92% |

$$
y = 1.003x + 1.8864
$$

$$
r^2 = 0.9998
$$

## Serum Potassium Linearity Percent Difference

| Ranks | Assigned (mg/dl) | ratio of high to low std. | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 1.08 | 0:1 | 1.075 | 0.00% |
| 2 | 1.84 | 1:9 | 1.875 | 1.90% |
| 3 | 2.6 | 2:8 | 2.600 | 0.00% |
| 4 | 3.36 | 3:7 | 3.200 | -4.76% |
| 5 | 4.12 | 4:6 | 4.300 | 4.37% |
| 6 | 4.88 | 5:5 | 4.925 | 0.92% |
| 7 | 5.64 | 6:4 | 5.700 | 1.06% |
| 8 | 6.4 | 7:3 | 6.225 | -2.73% |
| 9 | 7.16 | 8:2 | 7.025 | -1.89% |
| 10 | 7.92 | 9:1 | 7.925 | 0.06% |
| 11 | 8.68 | 1:0 | 8.675 | -0.06% |

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$$
y = 0.9919x + 0.0253
$$

$$
r^2 = 0.9981
$$

Serum Sodium Linearity Percent Difference

| Ranks | Assigned (mg/dl) | ratio of high to low std. | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 114 | 0:1 | 114.00 | 0.00% |
| 2 | 122.2 | 1:9 | 122.75 | 0.45% |
| 3 | 130.4 | 2:8 | 129.50 | -0.69% |
| 4 | 138.5 | 3:7 | 135.50 | -2.17% |
| 5 | 146.7 | 4:6 | 148.25 | 1.06% |
| 6 | 154.9 | 5:5 | 154.75 | -0.10% |
| 7 | 163.1 | 6:4 | 163.25 | 0.09% |
| 8 | 171.2 | 7:3 | 168.25 | -1.72% |
| 9 | 179.4 | 8:2 | 178.00 | -0.78% |
| 10 | 187.6 | 9:1 | 187.25 | -0.19% |
| 11 | 195 | 1:0 | 195.75 | 0.38% |

$$
y = 0.9969x - 0.0461
$$

$$
r^2 = 0.9967
$$

Serum Chloride Linearity Percent Difference

| Ranks | Assigned (mg/dl) | ratio of high to low std. | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 52.8 | 0:1 | 52.75 | 0.00% |
| 2 | 63 | 1:9 | 64.00 | 1.59% |
| 3 | 73.2 | 2:8 | 72.00 | -1.64% |
| 4 | 83.4 | 3:7 | 80.25 | -3.78% |
| 5 | 93.7 | 4:6 | 95.50 | 1.92% |
| 6 | 103.9 | 5:5 | 104.25 | 0.34% |
| 7 | 114.1 | 6:4 | 114.75 | 0.57% |
| 8 | 124.3 | 7:3 | 122.25 | -1.65% |
| 9 | 134.6 | 8:2 | 133.25 | -1.00% |
| 10 | 144.8 | 9:1 | 144.25 | -0.38% |
| 11 | 155 | 1:0 | 155.00 | 0.00% |

$$
y = 0.9953x + 0.0785
$$

$$
r^2 = 0.9974
$$

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Urine Potassium Linearity Percent Difference

| Ranks | Assigned (mg/dl) | ratio of high to low std. | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 11 | 0:1 | 11.00 | 0.00% |
| 2 | 28.21 | 1:9 | 29.40 | 4.22% |
| 3 | 45.41 | 2:8 | 47.15 | 3.83% |
| 4 | 62.62 | 3:7 | 65.25 | 4.20% |
| 5 | 79.82 | 4:6 | 82.20 | 2.98% |
| 6 | 97.03 | 5:5 | 99.50 | 2.55% |
| 7 | 114.23 | 6:4 | 115.88 | 1.44% |
| 8 | 131.44 | 7:3 | 132.90 | 1.11% |
| 9 | 148.64 | 8:2 | 149.93 | 0.86% |
| 10 | 165.84 | 9:1 | 165.23 | -0.37% |
| 11 | 183.05 | 1:0 | 183.05 | 0.00% |

$$
y = 0.9938 x - 1.8873
$$

$$
r^2 = 0.9994
$$

Urine Sodium Linearity Percent Difference

| Ranks | Assigned (mg/dl) | ratio of high to low std. | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 21 | 0:1 | 21.00 | 0.00% |
| 2 | 55.9 | 1:9 | 61.25 | 9.57% |
| 3 | 90.8 | 2:8 | 96.75 | 6.55% |
| 4 | 125.8 | 3:7 | 132.75 | 5.52% |
| 5 | 160.7 | 4:6 | 166.50 | 3.61% |
| 6 | 195.6 | 5:5 | 202.25 | 3.40% |
| 7 | 230.6 | 6:4 | 236.50 | 2.56% |
| 8 | 265.5 | 7:3 | 268.50 | 1.13% |
| 9 | 300.4 | 8:2 | 301.00 | 0.20% |
| 10 | 335.3 | 9:1 | 335.75 | 0.13% |
| 11 | 370.3 | 1:0 | 370.25 | -0.01% |

$$
y = 0.9886x + 5.9159
$$

$$
r^2 = 0.9994
$$

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Urine Chloride Linearity Percent Difference

| Ranks | Assigned (mg/dl) | ratio of high to low std. | mean of 4 rep. | % diff. from assigned |
| --- | --- | --- | --- | --- |
| 1 | 5 | 0:1 | 5.00 | 0.00% |
| 2 | 47 | 1:9 | 44.75 | -4.79% |
| 3 | 88.9 | 2:8 | 84.00 | -5.51% |
| 4 | 130.8 | 3:7 | 122.75 | -6.15% |
| 5 | 172.8 | 4:6 | 166.25 | -3.79% |
| 6 | 214.8 | 5:5 | 209.25 | -2.58% |
| 7 | 256.7 | 6:4 | 251.00 | -2.22% |
| 8 | 298.6 | 7:3 | 294.25 | -1.46% |
| 9 | 340.6 | 8:2 | 338.25 | -0.69% |
| 10 | 382.6 | 9:1 | 383.50 | 0.24% |
| 11 | 424.5 | 1:0 | 424.50 | 0.00% |

$$
y = 1.0062 - 4.8541
$$

$$
r^2 = 0.9995
$$

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

The applicant is not making a claim for a glucose calibrator or control but is recommending the use of an NIST-traceable Glucose Standard (100mg/dl) or serum calibrator. The glucose studies were conducted using the calibrator cleared under k810674.

Cleared under Medica EasyElectroLyte/RapidLyte Na/K/Cl Analyzer (k000926)

d. Detection limit:

Glucose

The lower limit of the reportable range is 1.0 mg/dl, which was defined by the sponsor as the lowest measurable analyte level with a CV less than or equal to 20%. The studies were conducted for 10 days with two runs per day using serum sample containing the analyte at 1mg/dl concentration.

The lower limit of the measuring range for the ISE assays was determined from the linear range study above.

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# e. Analytical specificity:

The applicant references Young, et al (Young, D.S., et al, Clin. Chem. 21:1D (1975)) for drugs and substances that may affect glucose values.

The applicant has tested glucose for the following:

Bilirubin to the level of $18\mathrm{mg / dl}$ has been found to exhibit $\leq 10\%$ interference in this assay. Hemoglobin to the level of $250\mathrm{mg / dl}$ has been found to exhibit $\leq 10\%$ interference in this assay. Intralipid has been found to exhibit $\leq 10\%$ interference in this assay to a level of $300\mathrm{mg / dl}$ .

The applicant has tested all the ISE assays for the following:

Bilirubin to the level of $20\mathrm{mg / dl}$ has been found to exhibit $\leq 10\%$ interference in this assay. Hemoglobin* to the level of $500\mathrm{mg / dl}$ has been found to exhibit $\leq 10\%$ interference in this assay. Intralipid has been found to exhibit $\leq 10\%$ interference in this assay to a level of $1000\mathrm{mg / dl}$ .

* Hemolysis: Hemoglobin had no interference with $\mathrm{K}^+$ due to the nature of the commercial Hemoglobin product having no $\mathrm{K}^+$ ion. However, hemolysis will interfere with $\mathrm{K}^+$ due to the high $\mathrm{K}^+$ concentration in erythrocytes. The sponsor has listed this interference in the PI.

# f. Assay cut-off:

Not Applicable

# 2. Comparison studies:

a. Method comparison with predicate device:

Method comparison using serum samples (vs. Hitachi 917)

| Item | N | r | Slope | Intercept | Range |
| --- | --- | --- | --- | --- | --- |
| GLU (mg/dL) | 60 | 0.9992 | 1.015 | -0.0288 | 27-593 |

Method comparison using serum samples (vs. EasyElectrolytes K/Na/Cl)

| Item | N | r | Slope | Intercept | Range |
| --- | --- | --- | --- | --- | --- |
| K (mmol/L) | 40 | 0.9983 | 0.986 | 0.124 | 2.9-6.9 |
| Na (mmol/L) | 40 | 0.9868 | 1.007 | -1.1 | 129.3-176.4 |
| CL (mmol/L) | 40 | 0.9894 | 0.973 | 4.35 | 75.6-129.8 |

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Method comparison using diluted urine samples (vs. EasyElectrolytes K/Na/Cl)

| Item | N | r | Slope | Intercept | Range |
| --- | --- | --- | --- | --- | --- |
| K (mmol/L) | 40 | 0.9992 | 0.967 | 0.34 | 11-84.4 |
| Na (mmol/L) | 40 | 0.9974 | 0.949 | -4.2 | 21-218 |
| CL (mmol/L) | 40 | 0.9895 | 0.997 | -6.5 | 62-286 |

b. Matrix comparison:
The plasma claim for the ISE electrodes was previously cleared under the Medica EasyElectroLyte/RapidLyte Na/K/Cl Analyzer (k000926).

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:

Glucose Normal range - 74-106 mg/dl
(as referenced by Tietz, N.W., Text Book of Clinical Chemistry, Philadelphia, W.B. Saunders, p.782 (1999))

ISE normal ranges
Chloride – serum: 98-107 mmol/L, 24 hour urine: 110-250 mmol/L
Sodium – serum: 136-145 mmol/L, 24 hour urine: 40-220 mmol/L
Potassium – serum: 3.5-5.1 mmol/L, 24 hour urine: 25-125 mmol/L
(as referenced by Tietz, N.W., Clinical Guide to Laboratory Tests, Philadelphia, W.B. Saunders, (1990))

N. Instrument Name:

Mindray, BS 200 Chemistry Analyzer

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O. System Descriptions:

1. Modes of Operation:
Random access instrument with ISE module

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:
Sample bar code option

4. Specimen Sampling and Handling:
Random access and stat mode operation
Samples are loaded on reagent wheel

5. Calibration:
Endpoint with sample blanking
Fixed-time
Kinetic
Linear calibration and nonlinear calibration methods

6. Quality Control:
Includes quality control program

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above:
Not Applicable

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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