BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER

K112377 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CFR · Mar 23, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112377
• Device Name: BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Mar 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The BS-400/CLC 720 Chemistry Analyzers are 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 plasma and urine 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

Automated clinical chemistry analyzer for in vitro diagnostic use in clinical laboratories. Inputs: serum, plasma, urine, or CSF samples. Operation: utilizes absorbance photometry for kinetic/endpoint assays and optional Ion-Selective Electrode (ISE) module for electrolyte (Na+, K+, Cl-) measurement. Principle: determines analyte concentration from standard curves generated with known concentrations. Output: quantitative clinical chemistry results. Operated by laboratory personnel. Healthcare providers use results to diagnose and monitor electrolyte imbalances, metabolic disorders, and carbohydrate metabolism conditions like diabetes.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A2; linearity per EP06-A; interference per EP07-A2; LoB/LoD/LoQ per EP17-A. Method comparison studies performed against Beckman Synchron CX7 (glucose) and BS-200 (ISE) using 110-218 patient samples. Glucose correlation r²=0.999-1.000; ISE correlation r²=0.994-0.999. No clinical studies required.

Technological Characteristics

Automated clinical chemistry analyzer. Sensing: absorbance photometry and Ion-Selective Electrodes (ISE). Connectivity: standalone. Software: automated analysis of photometric and ISE signals. Materials: standard laboratory analyzer components. Sterilization: N/A (in vitro diagnostic device).

Indications for Use

Indicated for clinical laboratory use to perform quantitative measurements of Na+, K+, Cl- in serum, plasma, and urine, and Glucose in serum, plasma, and urine. Used for diagnosis and treatment of electrolyte imbalances, metabolic disorders, and carbohydrate metabolism disorders (e.g., diabetes mellitus, neonatal/idiopathic 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

• SYNCHRON CX7 (K904219)
• BS-200 Chemistry Analyzer (K072018)
• GLUCOSE REAGENT, DERMA MEDIA LAB., INC. (K970664)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k112377

B. Purpose for Submission:
New submission for the BS-400/CLC 720 using previously cleared Glucose Reagent (k971467) and the same ISE module cleared under Mindray’s BS-200 Chemistry Analyzer (k072018)

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-400/CLC 720

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)

{1}

H. Intended Use:

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

2. Indication(s) for use:
The BS-400/CLC 720 Chemistry Analyzers are 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 plasma and urine 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.

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
BS-400/CLC 720 Chemistry Analyzers

I. Device Description:

The BS-400/CLC 720 are automated chemistry analyzers 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) 2000U/L, G6PDH (Leuconostoc mesenteroides) 4000U/L, ATP 1.1 mmol/L, NAD 2.7mmol/L, magnesium 2mmol/L, preservative and stabilizers. The reagent is manufactured by Carolina Liquid Chemistries for use on the BS-400/CLC 720 Chemistry Analyzers.

The ISE module is the same module as the one cleared on the BS- 200 analyzer and consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.

2 of 12

{2}

J. Substantial Equivalence Information:

1. Predicate device name(s): BS-200 Chemistry Analyzer
2. Predicate 510(k) number(s): k072018
3. Comparison with predicate:

BS-400 and BS-200

| Feature | BS-400 | BS-200 |
| --- | --- | --- |
| Indications | The BS-400/CLC 720 Chemistry Analyzers are 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 plasma and urine samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. | Same |
| System Function | | |
| System Control | Automatic, computer controlled | same |
| LIS external connectivity capability | Yes | same |
| Calibration/QC | Automatic and Manual calibration/QC | same |
| Barcode | Yes | same |
| Throughput (Max) | | |
| | 400 photometric tests per hour | 200 photometric tests per hour |
| Configuration | | |
| | Analytical unit, Operational Unit | same |
| Principle of Analysis | | |
| Mode of detection | Photometric | same |
| Analytical methods | Endpoint Fixed-time Kinetic | same |
| Calibration methods | Linear calibration and nonlinear calibration | same |
| Optical Measurement Unit | | |

{3}

| Feature | BS-400 | BS-200 |
| --- | --- | --- |
| Measurement Modes | Absorbance | same |
| Optical Modes | Monochromatic, Bichromatic | same |
| Photometer | Multi-wavelength diffraction grating spectrophotometer | same |
| Wavelength | 340nm, 380nm, 412nm, 450nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm | 340nm, 405nm, 450nm,410nm, 546nm, 578nm, 630nm, 670nm |
| Linear absorbance range | 0-3.0 absorbance | 0-4.0 absorbance |
| Light Source | Tungsten halogen lamp | same |
| Detector | Photodiode | same |
| Reaction Unit | | |
| Reaction cuvettes | Plastic or Glass 90 non-disposable | Plastics, 80 disposable |
| Reaction volume | 150~360μL | 180~500uL |
| Path length | 5mm | same |
| Reaction temperature | 37°C | same |
| Sample and Reagent System | | |
| Sample disk | 90 positions. 30 positions respectively for inner, middle and outer circles. | 40 sample tube positions on the outer circle |
| Reagent disk | 80 positions. 40 positions respectively for inner and outer circles | 40 reagent bottle positions on the inner circle of the sample disk |
| Pipettor System | Positive displacement stepper motor driven | same |
| Refrigerator temperature | 2-10°C | 4-15°C |
| Sample Dispense | 2μL -45μL | 3μl -45μl |
| Reagent Dispense | 20μL-350μL | 30μl-450μl |
| POWER | | |
| Input | 110/115V~, 60Hz | 100-130V ,50/60±1 Hz |
| Operating environmental conditions | | |

4 of 12

{4}

| Feature | BS-400 | BS-200 |
| --- | --- | --- |
| Temperature | 15°C to 30°C | same |
| Humidity | 35% to 80%, non-condensing | Same |
| | ISE (ion selective electrode technology) | same |
| Sample Type | | |
| | Serum, plasma, or diluted urine | same |
| Test | | |
| | Na+, K+, Cl | same |
| Sample Size | | |
| | 70 μL Serum, plasma mode; 140 μL Urine mode | same |
| ISE Calibration | | |
| | Two-point and single-point calibrations | same |

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

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

# L. Test Principle:

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.

{5}

M. Performance Characteristics (if/when applicable):

These studies are intended to verify use of photometric and ISE technology on the analyzer.

1. Analytical performance:

a. Precision/Reproducibility:

Repeatability and within device imprecision for both serum/control and urine specimens are shown through the replicate assay of specimen pools and control materials over twenty days as described in CLSI document EP5-A2

Imprecision statistics are summarized below.

Imprecision of Glucose Measurements (in mg/dL)

| | | | | Repeatability | | Within Device Imprecision | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Specimen | Sample | n | mean | SD | %CV | SD | %CV |
| Serum | | | | | | | |
| | Control pool 1 | 120 | 56.3 | 0.57 | 1.0% | 0.88 | 1.6% |
| | Serum Pool | 120 | 117.0 | 0.83 | 0.7% | 1.74 | 1.5% |
| | Control pool 2 | 120 | 561.6 | 3.42 | 0.6% | 6.84 | 1.2% |
| Urine | | | | | | | |
| | Urine pool 1 | 117 | 14.9 | 0.26 | 1.7% | 0.32 | 2.1% |
| | Urine pool 2 | 117 | 194.3 | 1.08 | 0.6% | 1.91 | 1.0% |
| | Urine pool 3 | 120 | 330.0 | 1.80 | 0.5% | 2.95 | 0.9% |

ISE within-run precision

| Item | Level I | | | Level II | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean | SD | CV% | Mean | SD | CV% |
| Serum K+ (mmol/L) | 3.49 | 0.02 | 0.54% | 6.21 | 0.03 | 0.43% |
| Serum Na+ (mmol/L) | 128.1 | 0.63 | 0.49% | 150.8 | 0.50 | 0.33% |
| Serum Cl- (mmol/L) | 84.8 | 0.95 | 1.12% | 117.9 | 0.51 | 0.44% |
| | Urine Level I | | | Urine Level II | | |
| Urine K+ (mmol/L) | 21 | 0.51 | 2.48% | 44 | 0.00 | 0.00% |
| Urine Na+ (mmol/L) | 65 | 1.60 | 2.46% | 124 | 1.81 | 1.47% |
| Urine CL- (mmol/L) | 53 | 1.08 | 2.03% | 106 | 1.15 | 1.08% |

ISE Total precision

| Item | Level I | | | Level II | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean | SD | CV% | Mean | SD | CV% |
| Serum K+ (mmol/L) | 3.48 | 0.03 | 0.78 | 6.17 | 0.04 | 0.64 |
| Serum Na+ (mmol/L) | 129.1 | 1.00 | 0.78 | 150.4 | 0.89 | 0.59 |
| Serum Cl- (mmol/L) | 85.1 | 1.10 | 1.29 | 117.1 | 0.96 | 0.82 |
| | Urine Level I | | | Urine Level II | | |
| Urine K+ (mmol/L) | 21 | 0.47 | 2.23 | 44 | 0.24 | 0.56 |
| Urine Na+ (mmol/L) | 67 | 3.19 | 4.75 | 126 | 3.45 | 2.74 |
| Urine CL- (mmol/L) | 56 | 2.13 | 3.83 | 108 | 2.02 | 1.87 |

{6}

b. Linearity/assay reportable range:

Linearity claims for both the serum and urine applications are validated using procedures based on CLSI document EP06-A

## Glucose

A first set of 0, 5, 25, 50, 100, 200, 300, 400, 500, 600 and 700 mg/dL glucose (NIST SRM 917c) in a matrix of 7 g/dL BSA, 0.85% sodium chloride, and an inert preservative for the serum/plasma application.

A second, analogous set of standards was similarly prepared in an aqueous matrix without BSA for the urine application.

## ISE

Linearity samples were prepared by using low and high samples with serial dilution schemes to cover 11 points in the test range.

| Measuring Range | | |
| --- | --- | --- |
| Glucose mg/dL Serum/Plasma Based on LOQ and Linearity y = 0.999x + 0.777 R² = 1 | 5 | 700 |
| Glucose Urine mg/dL Based on LOQ and Linearity y = 1.002x + 0.610 R² = 1 | 2 | 700 |
| ISE Based on Linearity and supported by LOQ | | |
| K (mmol/L) serum(ISE) y = 1.0007x - 0.0051 R² = 0.9998 | 0.94 | 8.2 |
| Na (mmol/L) serum(ISE) y = 1.0001x - 0.0038 R² = 0.9998 | 71 | 232.3 |
| CL (mmol/L) serum(ISE) y = 1.0001x - 0.015 R² = 0.9999 | 50 | 198 |
| K (mmol/L) Urine(ISE) y = 0.9998x + 0.0203 R² = 0.9987 | 3.5 | 209.3 |
| Na (mmol/L) Urine(ISE) y = 1.0000x - 0.0024 R² = 0.9999 | 9.25 | 725.5 |
| CL (mmol/L) Urine(ISE) y = 0.9999x + 0.0129 R² = 0.9986 | 7.25 | 693.3 |

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Cleared under Point Multi-Analyte Chemistry Calibrator (k070207) Cleared under Medica EasyElectroLyte/RapidLyte Na/K/Cl Analyzer (k000926)

d. Detection limit:

The limits of blank (LoB) and detection (LoD) are listed below with the number of determinations they are based on. These limits were determined consistent with the guidelines of CLSI protocol EP17-A with proportions of false positives less than 5% and false negatives less than 5%.

7 of 12

{7}

8 of 12

Glucose

| Specimen | n | LoB | LoD | LOQ |
| --- | --- | --- | --- | --- |
| Serum | 80 | 2.2 | 2.6 | 5.0 mg/dL |
| Urine | 60 | 0.6 | 0.9 | 1.0 mg/dL |

ISE

| Item | n | LoB | LoD | LoQ |
| --- | --- | --- | --- | --- |
| Serum | | | | |
| K (mmol/L) | 60 | 0.06 | 0.08 | 0.48 |
| Na (mmol/L) | 60 | 0.92 | 1.41 | 3.27 |
| CL (mmol/L) | 60 | 1.12 | 1.94 | 5.04 |
| Urine | | | | |
| K (mmol/L) | 60 | 1.50 | 1.76 | 3.01 |
| Na (mmol/L) | 60 | 3.50 | 6.88 | 11.22 |
| CL (mmol/L) | 60 | 1.00 | 2.96 | 5.55 |

e. Analytical specificity:

Glucose

Effects of potentially interfering substances are shown by spiking serum pools with increasing amounts of interferent and measuring the effect of the additions on results. Bilirubin, hemoglobin, and Intralipid® 20% Emulsion are used to estimate icterus, hemolysis, and lipemia interference.

| Interferent | Glucose Concentration | Interferent Concentration | Change in Glucose Result |
| --- | --- | --- | --- |
| Ascorbic acid | 76 mg/dL | 30 mg/L† | -0.1 mg/dL* |
| | 140 mg/dL | 30 mg/L† | -0.8 mg/dL* |
| Bilirubin | 78 mg/dL | 4.8 mg/dL | -2.6 mg/dL |
| | | 8.0 mg/dL | -4.0 mg/dL |
| | 138 mg/dL | 8.0 mg/dL | -3.3 mg/dL |
| | | 16.0 mg/dL | -6.9 mg/dL |
| Hemoglobin | 74 mg/dL | 400 mg/dL† | -2.0 mg/dL |
| | 134 mg/dL | 400 mg/dL† | -3.8 mg/dL |
| Triglycerides (non-turbid) | 69 mg/dL | 728 mg/dL | +2.3 mg/dL |
| | | 910 mg/dL | +3.0 mg/dL |
| | 115 mg/dL | 742 mg/dL | +2.2 mg/dL |
| | | 927 mg/dL† | +2.7 mg/dL |
| Metronidazole | 75 mg/dL | 24 mg/L | +2.6 mg/dL |
| | | 48 mg/L | +5.6 mg/dL |
| | 137 mg/dL | 24 mg/L | +3.1 mg/dL |
| | | 48 mg/L | +5.1 mg/dL |

{8}

| Tetracycline | 76 mg/dL | 15 mg/L† | -1.5 mg/dL |
| --- | --- | --- | --- |
| | 140 mg/dL | 15 mg/L† | -1.5 mg/dL |
| EDTA | 76 mg/dL | 8 mg/mL† | +0.2 mg/dL* |
| | 145 mg/dL | 8 mg/mL† | -0.1 mg/dL* |
| Potassium oxalate | 76 mg/dL | 8 mg/dL† | +0.0 mg/dL* |
| | 146 mg/dL | 8 mg/dL† | -0.8 mg/dL* |
| Sodium citrate | 76 mg/dL | 140 mg/dL† | -1.1 mg/dL |
| | 145 mg/dL | 140 mg/dL† | -2.8 mg/dL |
| Sodium fluoride | 77 mg/dL | 10 mg/dL† | +0.1 mg/dL* |
| | 145 mg/dL | 10 mg/dL† | +0.9 mg/dL* |

* Result is statistically insignificant at p=0.05.
† Highest level tested.

Serum pools containing 73 mg/dL and 121 mg/dL glucose and respectively spiked with 50 mg/dL and 60 mg/dL Intralipid® give lipemia index values of 47.1 and 54.9. Both pools appear moderately lipemic.

Visibly lipemic specimens with lipemic index values greater than 47 may produce elevated results. Assay these specimens using the Glucose (Blanked) Application.

ISE

Interference: Interference studies were performed based on CLSI document EP7-A2, the test results are showing below with no interference up to the amounts tested.

| Item | Interference materials | | |
| --- | --- | --- | --- |
| | Hemoglobin | Bilirubin | Lipemia Intralipids® |
| K (mmol/L) | 500 mg/dL | 40 mg/dL | 1000 mg/dL |
| Na (mmol/L) | 500 mg/dL | 40 mg/dL | 1000 mg/dL |
| CL (mmol/L) | 500 mg/dL | 40 mg/dL | 1000 mg/dL |

Note: Hemolysis: Hemoglobin had no interference to serum K⁺ due to Hemoglobin used not having K⁺, but Hemolysis will interfere with K⁺ due to the high K⁺ concentration in erythrocytes.

f. Assay cut-off: Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

Method comparison using 110 serum and 108 plasma samples (vs. Beckman

{9}

Synchron CX7)

| Item | Specimen | N | r2 | Slope | Intercept | Range |
| --- | --- | --- | --- | --- | --- | --- |
| GLU (mg/dL) | Serum + Plasma | 218 | 0.999 | 0.989 | 1.31 | 38 – 672 |
| GLU (mg/dL) | Serum | 110 | 1.000 | 0.992 | 1.40 | 38 – 672 |
| GLU (mg/dL) | Plasma | 108 | 0.999 | 0.986 | 1.22 | 42 – 672 |

Method comparison using urine samples (vs. Beckman Synchron CX7)

| Item | N | r2 | Slope | Intercept | Range |
| --- | --- | --- | --- | --- | --- |
| GLU (mg/dL) | 108 | 1.000 | 1.001 | 1.36 | 2 – 660 |

ISE analysis (vs. BS-200 Chemistry Analyzer)

| Item (mmol/L) | Regression Slope | Regression Intercept | Correlation coefficient square R2 | Analyze Range of BS-400 (mmol/L) | Sample numbers |
| --- | --- | --- | --- | --- | --- |
| Serum K+ | 1.0097 | 0.0591 | 0.997 | 0.93~8.18 | 40 |
| Serum Na+ | 1.0092 | -0.7885 | 0.9975 | 70.7~232.3 | 40 |
| Serum Cl- (mmol/L) | 0.9763 | 1.3848 | 0.9946 | 49.5~198.0 | 40 |
| Urine K+ | 0.9718 | 1.7022 | 0.9996 | 4~210 | 40 |
| Urine Na+ | 1.0249 | -13.487 | 0.9994 | 12~725 | 40 |
| Urine Cl- | 0.9984 | 2.1591 | 0.9996 | 7~690 | 40 |

b. Matrix comparison:

See 2.a method comparison above for glucose plasma and urine and ISE urine claim. 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

Sample Conventional Units SI Units

{10}

Serum/Plasma 74 to 100 mg/dL 4.1 to 5.1 mmol/L
Urine, Random 1 to 15 mg/dL 0.1 to 0.8 mmol/L
Urine, 24 hour < 0.5 g/day < 2.87 mmol/day

Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Elsevier Inc., St. Louis, MO, 2006.

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
Chloride – serum: 98-107 mmol/L, 24 hour urine: 110-250 mmol/L

Tietz, N.W., Clinical Guide to Laboratory Tests, Philadelphia, W.B. Saunders, 1990

## N. Instrument Name:

BS-400/CLC 720 Chemistry Analyzer

## O. System Descriptions:

1. Modes of Operation:

Random access instrument with ISE module

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?:

Yes ☐ or No ☐ X

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:

11 of 12

{11}

Random access and stat mode operation Samples are loaded on sample disk

5. Calibration:
Linear calibration and nonlinear calibration

6. Quality Control:
Includes quality control program

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.

12 of 12