PRESTIGE 24I; BIOLIS 24I; MGC 240

K103531 · Tokyo Boeki Medisys, Inc. · CFR · Dec 1, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103531
• Device Name: PRESTIGE 24I; BIOLIS 24I; MGC 240
• Applicant: Tokyo Boeki Medisys, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Dec 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic including glucose. An optional lon Selective Electrode Module is intended to measure sodium, potassium and chloride. The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.

Device Story

Discrete, random-access clinical chemistry analyzer; automates pipetting, heating, and photometric measurement. Inputs: human serum samples; reagents. Principle: photometry (glucose hexokinase assay) at 340 nm; optional indirect potentiometry (ISE module) for electrolytes. Output: quantitative analyte concentrations. Used in clinical laboratory settings by trained personnel. Automates manual analytical procedures; provides rapid, standardized results for diagnostic decision-making regarding metabolic disorders. Benefits: increased throughput (240 tests/hr), reduced manual error, and consistent diagnostic data.

Clinical Evidence

Bench testing only. Method comparison against Beckman CX-7 showed correlation coefficient 0.999, slope 0.974, intercept 2.22. Precision studies (N=60 per sample) showed CVs 1.1-1.5%. Total imprecision (N=80) showed CVs 1.9-2.5%. Linearity range 25-500 mg/dL (r=0.9982). Sensitivity: LoB 3.64 mg/dL, LoD 5.64 mg/dL, LoQ 10 mg/dL. Interference testing performed for ascorbic acid, bilirubin, hemoglobin, lipemia, metronidazole, and tetracycline.

Technological Characteristics

Discrete, random-access photometric analyzer. Light source: tungsten halogen lamp. Detector: photo-diode. Wavelength range: 340-800 nm. Reaction cuvettes: plastic, semi-disposable. Path length: 8 mm. Incubation: 37°C ± 0.1°C. Optional ISE module for electrolytes. Software revision: 1.26.

Indications for Use

Indicated for quantitative measurement of glucose in human serum for diagnosis and treatment of carbohydrate metabolism disorders (diabetes mellitus, neonatal hypoglycemia, idiopathic glycemia) and pancreatic islet cell carcinoma. Optional module measures sodium, potassium, and chloride in serum.

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 CX 7 (K904219)

Reference Devices

• Glucose hexokinase (K802810)
• Pointe Scientific Chemistry Calibrator (K070207)

Submission Summary (Full Text)

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K103531

#### Tokyo Boeki Medisys Inc. 1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0051, Japan Phone: [phone] Fax: [phone]

DEC - 1 2011

# 5. 510(k) SUMMARY

# Submitter's Name/Address

| Submitter's Name: | Tokyo Boeki Medisys Inc. |
|------------------------------------|------------------------------------------------|
| Submitter's Address: | 1-14-21 Higashi-Toyota, Hino<br>Tokyo 191-0052 |
| Phone: | [phone] |
| Fax: | [phone] |
| Establishment Registration Number: | 3004378324 |
| Owner/Operator Number: | 9060135 |

#### Contact Person (United States Agent)

| Name of Agent: | James M. Clinton |
|------------------------|----------------------------------------|
| Agent's Business Name: | Quality and Regulatory Consulting, LLC |
| Street Address: | 5105 Fairoaks Road |
| | Durham, NC 27712-2078 |
| Phone: | 919-247-0479 |
| Fax: | 919-287-2551 |
| E-mail address: | [e-mail] |

#### Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common Name:

October 25, 2011

Biolis 24i, MGC 240 and Prestige 24i, (These are the same models except the names)

Clinical Chemistry Analyzer (with optional ISE Module)

Classification Numbers/Class:

75JJE, Class I 75CFR Class II

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# vo Boeki Medisv

1-14-21 Higashi-Tovoda. Hino. Tokvo 191-0 Phone: [phone] Fax: [phone]

### 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 : k103531

### Description:

Using photometry, the Biolis 24i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 24i with lon-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

### Intended Use:

The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic including glucose. An optional lon Selective Electrode Module is intended to measure sodium, potassium and chloride.

The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.

### Substantial Equivalence:

Substantial equivalence has been demonstrated between the Beckman CX-7 (K904219) and the Biolis 24i. These analyzers are calibrated with known concentration calibrator material and both measure specific concentrations using photometry.

| Item | New Device<br>Biolis 24i | Predicate<br>SYNCHRON CX 7 (K904219) |
|-------------------|----------------------------------------------------------|----------------------------------------------|
| General | | |
| System Principle | Discrete, single line random access, multi-test analysis | Discrete, random access, multi-test analysis |
| Throughput | 240 tests | 225 tests/hr (photometric only) |
| Configuration | Analytical unit, Control unit | Analytical unit, Control unit |
| Measurement modes | Absorbance | Absorbance |

Comparison with predicate:

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# Tokyo Boeki Medisys Inc.

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0051, Japan
Phone: [phone]

| Detector | Photo-diode | Diffraction grating, photodiode array |
|------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Optical system | Wavelength range of 340 to 800nm | 340, 380, 410, 470, 520, 560, 600, 650, 670, 700 nm |
| Light source | Tungsten halogen lamp | xenon |
| Reaction cuvettes | Plastics, semi disposal | quartz |
| Path length | 8mm | 5 mm |
| Reaction time | Maximum 10min. | Maximum 12 min. |
| Incubation temperature | 37°C +/- 0.1°C | same |
| Glucose | | Glucose hexokinase 510(k): k802810 |
| Intended use | Quantitative determination of glucose in serum | Quantitative determination of glucose in serum plasma, urine, CSF |
| Method | Photometric endpoint using glucose hexokinase. | Same |
| Sample type | Serum | Serum, plasma, urine, CSF |
| Sample Volume | 3 uL | same |
| Reaction Time | 5 min<br>` Analysis time<br>Read period: 52 - 54 points<br>(15 seconds per point) | 5 min |

The validated system is described below.

.. .

.

| Analyzer: | Tokyo Boeki BioLis 24i Analyzer, software revision: 1.26<br>Serial numbers are listed on individual data sheets. | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Reagent: | Carolina Liquid Chemistries Glucose Reagent, Kit product no. BL-208 (also<br>packaged as AU-208). Lot numbers are listed on individual data sheets. | | |
| Application<br>parameters: | Sample volume: 3 µL<br>Reagent volume: 310 µL<br>Wavelengths: 340 / 405 nm<br>Reaction type: Endpoint<br>Read period: 52 - 54 | | |
| Calibrator: | Pointe Scientific Chemistry Calibrator<br>product no. C7506-50, lot 11802, exp. March 2014<br>Premarket clearance reference no.: K070207 | | |
| | The 185 mg/dL glucose set point for the Pointe Calibrator was verified for the<br>Carolina Liquid Chemistries Glucose Reagent by comparing the calibrator to NIST<br>SRM 965b, Glucose in Frozen Serum. The Pointe Calibrator was assayed eight<br>times over each of four analytical runs against NIST standard levels 3 and 4 which<br>were each assayed in duplicate. The glucose concentration of the Pointe Calibrator<br>was calculated for each run by linear interpolation the NIST assay values and their<br>respective certified values of 118.5 mg/dL and 294.5 mg/dL. The mean glucose<br>result of the Pointe Calibrator over the four runs was 185.6 mg/dL. | | |

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# Tokyo Boeki Medisys Inc.

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0051, Japan Phone: [phone] Fax: [phone]

## Performance Characteristics <Glucose Hexokinase >

# Method Comparison

A correlation analysis between the Beckman CX-7 and the Biolis 24i yielded the following results:

| Representative<br>Method | Correlation<br>Coefficient | Slope<br>(Least-Squares) | Y-axis intercept |
|--------------------------|----------------------------|--------------------------|------------------|
| GLU | 0.999 | 0.974 | 2.22 |

### Precision

Repeatability

| Sample | N | Mean | SD | CV(%) |
|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----|-------|
| Serum 1 | રેત્વે છે. વિશ્વિત દિવસ (Career) તાલુકાઓ પૈકીના એક એવા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલ | 60.3 | 0.8 | 1.3% |
| Serum 2 | 60 | 106.4 | 1.4 | 1.3% |
| Serum 3 | 60 | 116.8 | 1.4 | 1.2% |
| Serum 4 | 60 | 192.1 | 2.2 | 1.1% |
| Serum 5 | 60 | 446.2 | 6.8 | 1.5% |

#### Total Imprecision Study

| Analyzer s/n | Sample | n | mean | SD | %CV |
|--------------|--------------|----|-------|------|------|
| 2229450610 | Control 1 | 80 | 63.2 | 1.5 | 2.4% |
| 2229450610 | Serum Pool 1 | 80 | 118.1 | 2.9 | 2.5% |
| 2229450610 | Serum Pool 2 | 80 | 188.8 | 4.1 | 2.1% |
| 2229450610 | Control 2 | 80 | 447.0 | 10.5 | 2.3% |
| 2227671109 | Control 1 | 80 | 63.2 | 1.2 | 1.9% |
| 2227671109 | Serum Pool 1 | 80 | 117.6 | 2.7 | 2.3% |
| 2227671109 | Serum Pool 2 | 80 | 186.9 | 3.6 | 1.9% |
| 2227671109 | Control 2 | 80 | 445.9 | 9.8 | 2.2% |

#### Linearity

The linearity test yielded the following results:

| Correlation | 0.9982 |
|-------------|----------------|
| Slope | 0.948 |
| Intercept | 2.45 |
| Range | 25 - 500 mg/dL |

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# Tokyo Boeki Medisys Inc.

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0051, Japan Phone: [phone] Fax: [phone]

# Sensitivity

| | mg/dL |
|-----|-------|
| LoB | 3.64 |
| LoD | 5.64 |
| LoQ | 10 |

#### Interferences

| Interferent | Interferent<br>Concentration | Glucose<br>Concentration | Observed<br>Interference |
|------------------------------|------------------------------|--------------------------|--------------------------|
| Ascorbic acid | 30 mg/L | 75 mg/dL<br>140 mg/dL | none |
| Bilirubin | 4.8 mg/dL<br>6.4 mg/dL | 90 mg/dL<br>146 mg/dL | -3.3 mg/dL<br>-3.6% |
| Hemoglobin | 240 mg/dL<br>160 mg/dL | 76 mg/dL<br>139 mg/dL | -3.6 mg/dL<br>-3.8%* |
| Lipemia<br>(from Intralipid) | 600 mg/dL<br>80 mg/dL | 72 mg/dL<br>142 mg/dL | + 4 mg/dL<br>+ 3.9% |
| Metronidazole | 24 mg/L<br>48 mg/L | 76 mg/dL<br>139 mg/dL | + 2.4 mg/dL<br>+ 3.1% |
| Tetracycline | 15 mg/L | 76 mg/dL<br>141 mg/dL | none |

#### Conclusion

The data demonstrates that Biolis 241 is substantially equivalent to Beckman SYNCHRON CX 7 (K904219) and that the CLC Glucose Reagent is substantially equivalent to Beckman Glucose Reagent (K802810).

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Image /page/5/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 caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Tokyo Boeki Medisys Inc. c/o James M Clinton US Agent 5105 Fairoaks Road, Durham, NC 27712

DEC - 1 2011

Re: k103531

Trade/Device Name: Biolis 24i Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system Regulatory Class: II Product Code: CFR, JJE Dated: November 4, 2011 Received: November 8, 2011

Dear Mr. Clinton:

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 yours,

N

Countney 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): k103531

Device Name: Biolis 24i Clinical Chemistry Analyzer

Indications for Use:

The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various andytes af diagnostic interest including glucose.

The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic isle cell carcinoma.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Ruth Clark

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 103531

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