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

Intended Use

The BS-400 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories. The analyzer is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples.

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. Performance evaluated via correlation analysis, precision, linearity, LoD/LoQ, and interference studies. Correlation with predicate devices (n=218 for Glucose; n=40 for electrolytes) showed high R² values (0.9957–0.9996). Precision studies (n=117-120) demonstrated low CV% (Within-run: 0.5%–2.48%; Between-run: 0.56%–4.75%). Linearity and interference testing confirmed performance within specified ranges for serum, plasma, and urine samples.

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)

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KI12377

MAR 2 3 2012

510 (k) Summary

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The assigned 510(k) number is: _ ______________

# Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: [phone] Fax: [phone]

- Contact Person:
- Tan Chuanbin

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

- Date Prepared:
July 26, 2011

### Name of the device:

- . Trade/Proprietary Name: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer
(BS-400 and CLC 720 are the same analyzers except the Models. For convenience of explanation, the BS-400 Chemistry Analyzer is represented of the two in this summary.)

- . Common Name: Clinical Chemistry Analyzer (with optional ISE Module)
- Classification Number/Class: ●

75JJE, Class I 75CRF, Class II 75CEM, Class II

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75CGE, Class II 75JGS, Class II

# Legally Marketed Predicate Device:

SYNCHRON CX7, BECKMAN K904219 K072018 BS-200 Chemistry Analyzer, Mindray K970664 GLUCOSE REAGENT, DERMA MEDIA LAB., INC.

# Description:

The BS-400/CLC 720 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K970664 and is the chosen assay to demonstrate performance for the photometric unit. The BS-400 Chemistry Analyzer has an optional lon-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.

#### Intended Use:

The BS-400 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories. The analyzer is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples.

# Comparison of Technological Characteristics:

Substantial equivalence has been demonstrated between the BS-400 Chemistry Analyzer and SYNCHRON CX7 analyzer. Both of them utilize absorbance photometry to perform and output quantitative results for kinetic and endpoint clinical chemistries. For analytes, the BS-400 Chemistry Analyzer and SYNCHRON CX7 analyzer determine the concentration of unknown samples from a standard curve generated with known analyte concentrations. The BS-400 Chemistry Analyzer and BS-200 Chemistry Analyzer both utilize Ion-Selective Electrodes technology and are equipped with the same ISE Module.

### Performance Characteristics:

Performance testing of the BS-400 Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-400 to evaluate precision, linearity, and method comparison, Limits of Detection and Limits of Quantitation, interference.

A correlation analysis between the BS-400 Chemistry Analyzer and the predicate devices yielded

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#### 510 (k) Summary

the following results:

| Item | Regression<br>slope | Regression intercept | Correlation<br>coefficient<br>square R² | Sample<br>numbers |
|--------------------------|---------------------|----------------------|-----------------------------------------|-------------------|
| GLU (mg/dL) | 0.989 | 1.31 | 0.999 | 218 |
| Serum K+ (mmol/L) (ISE) | 1.0139 | 0.0384 | 0.9973 | 40 |
| Serum Na+ (mmol/L) (ISE) | 1.0101 | -0.9322 | 0.9975 | 40 |
| Serum Cl- (mmol/L) (ISE) | 0.9837 | 0.5059 | 0.9957 | 40 |
| Urine K+ (mmol/L) (ISE) | 0.9671 | 2.1934 | 0.9996 | 40 |
| Urine Na+ (mmol/L) (ISE) | 1.0256 | -13.841 | 0.9994 | 40 |
| Urine Cl- (mmol/L) (ISE) | 0.9981 | 2.4059 | 0.9996 | 40 |

Precision of Glucose test yielded the following results:

.

・

. .

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

The Within-Run precision of ISE module test yielded the following results:

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.

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

The Between-run imprecision of ISE module test yielded the following results:

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

The linearity test yielded the following results: ·

| Item | Linear range | |
|-------------------------------------------|--------------|-------------|
| | Lower limit | Upper limit |
| GLU ( mg/dL )<br>(Specimen :Serum/Plasma) | 5 | 700 |
| GLU (mg/dL) (Specimen :Urine) | 2 | 700 |

・

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^{510 (}k) Summary

| K (mmol/L) serum(ISE) | 0.94 | 8.18 |
|------------------------|-------|--------|
| Na (mmol/L) serum(ISE) | 71.00 | 232.28 |
| CL (mmol/L) serum(ISE) | 49.60 | 198.18 |
| K (mmol/L)Urine(ISE) | 3.50 | 209.25 |
| Na (mmol/L) Urine(ISE) | 9.25 | 725.50 |
| CL (mmol/L)Urine(ISE) | 7.25 | 693.25 |

The Limit of Detection test yielded the following results:

| Item | LoB | LoD | LoQ |
|-------------------------------|------|------|-------|
| GLU (mg/dL) (Specimen :Serum) | 2.2 | 2.6 | / |
| GLU (mg/dL) (Specimen :Urine) | 0.6 | 0.9 | / |
| K (mmol/L) serum(ISE) | 0.07 | 0.10 | 0.52 |
| Na (mmol/L) serum(ISE) | 1.28 | 2.06 | 4.38 |
| CL (mmol/L) serum(ISE) | 2.30 | 3.56 | 5.12 |
| K (mmol/L) Urine(ISE) | 1.50 | 2.42 | 3.70 |
| Na (mmol/L) Urine(ISE) | 5.50 | 8.98 | 10.98 |
| CL (mmol/L)Urine(ISE) | 3.50 | 5.91 | 7.15 |

The Interference of Glucose test yielded the following results:

Effects of icterus, hemolysis, and lipemia are shown by spiking serum pools with bilirubin, hemoglobin, and Intralipid® 20% emulsion. Other substances are also tested. Interference is defined as a shift in results by more than both 3 mg/dL and 3%.

| Interferent | Glucose<br>Concentration | Interferent<br>Concentration | Observed<br>Interference |
|-------------------------------|--------------------------|------------------------------|--------------------------|
| Ascorbic acid | 76 mg/dL<br>140 mg/dL | 30 mg/L | none |
| Bilirubin | 78 mg/dL<br>138 mg/dL | 5.4 mg/dL<br>9.8 mg/dL | -3%*<br>-3%* |
| Hemoglobin | 74 mg/dL<br>134 mg/dL | 400 mg/dL | none |
| Lipemia (from<br>Intralipid®) | 72 mg/dL<br>139 mg/dL | 400 mg/dL<br>67 mg/dL | + 3.1 mg/dL<br>+3%* |

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#### 510 (k) Summary

| Metronidazole | 75 mg/dL | 27 mg/L | + 3 mg/dL* |
|-------------------|-----------------------|-----------|------------|
| | 137 mg/dL | 35 mg/L | + 3%* |
| Tetracycline | 76 mg/dL<br>140 mg/dL | 15 mg/L | none |
| EDTA | 76 mg/dL<br>145 mg/dL | 8 mg/mL | none |
| Potassium oxalate | 76 mg/dL<br>146 mg/dL | 8 mg/dL | none |
| Sodium citrate | 76 mg/dL<br>145 mg/dL | 140 mg/dL | none |
| Sodium fluoride | 77 mg/dL<br>145 mg/dL | 10 mg/dL | none |

*Amount of interference is interpolated from the results of adjacent spiked samples.

The Interference of ISE module test yielded the following results:

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

# Conclusion:

The data demonstrates that the BS-400 Chemistry Analyzer is substantially equivalent to SYNCHRON CX7 Analyzer and BS-200 Chemistry Analyzer.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads facing to the right.

#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Shenzhen Mindray Bio-Medical Electronics Co., Ltd c/o Susan D. Goldstein-Falk MDI Consultants, Inc 55 Northern Blvd., Suite 200 Great Neck, NY 11021

MAR 2 3 2012

Re: k112377

Trade/Device Name: BS-400/CLC 720 Chemistry Analyzer · Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JGS, CEM, CGZ, JJE Dated: March 9, 2012 Received: March 12, 2012

Dear Ms. Goldstein-Falk,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ... .

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours.

N

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k112377

Device Name: BS-400/CLC 720 Chemistry Analyzer

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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Omoce Evaluation and Safety

510(k) K(112327)

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