BIOLIS 12I

K110520 · Tokyo Boeki Medisys, Inc. · CEM · Mar 23, 2012 · Clinical Chemistry

Device Facts

• Record ID: K110520
• Device Name: BIOLIS 12I
• Applicant: Tokyo Boeki Medisys, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Mar 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Biolis 12i is a discrete chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing. It is for vitro diagnostic use only. 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. The Biolis 12i 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.

Device Story

Biolis 12i is an automated, discrete, random-access clinical chemistry analyzer; processes serum samples for sodium, potassium, chloride, and glucose. System components include sampler, reagent/reaction trays, mixing units, cuvette washing, and spectrophotometer. ISE module uses potentiometry (ion-selective electrodes) for electrolytes; photometry (340 nm) for glucose hexokinase assay. Throughput: 90-100 tests/hour. Operated by laboratory personnel in clinical settings; not for point-of-care. Operator loads samples into cups on tray; system performs automatic aspiration and analysis. Results displayed to clinician for diagnosis/treatment of metabolic and electrolyte disorders. Benefits include automated, high-throughput quantitative analysis of patient serum.

Clinical Evidence

Bench testing only. Performance validated through method comparison studies against predicate devices (Sirrus and Prestige 24i). Correlation coefficients: Na (0.9872), K (0.9992), Cl (0.9922), Glucose (0.9975). Precision (CV%) for glucose within-run 1.04-1.31%, between-run 0.70-0.87%. ISE precision (CV%) within-run 0.61-0.94%, day-to-day 0.3-1.0%. Linearity ranges: Na 100-200 mmol/L, K 1-10 mmol/L, Cl 70-200 mmol/L, Glucose 25-540 mg/dL. No significant interference observed for bilirubin, hemoglobin, or lipemia at specified concentrations.

Technological Characteristics

Discrete, random-access analyzer. Photometric detection via photo-diode (340-800nm range) using tungsten halogen lamp. ISE module for potentiometry. Semi-disposable plastic cuvettes (8mm path length). Incubation at 37°C +/- 0.1°C. Throughput: 90-100 tests/hour. Connectivity: Analytical unit and control unit interface.

Indications for Use

Indicated for quantitative measurement of sodium, potassium, chloride, and glucose in human serum for diagnosis and treatment of electrolyte imbalances, metabolic disorders, diabetes mellitus, neonatal hypoglycemia, idiopathic glycemia, and pancreatic islet cell carcinoma. Not for point-of-care testing.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• Tokyo Boeki Prestige 24i (ISE) (k040958)
• Beckman CX-7 system (glucose) (k971467)

Submission Summary (Full Text)

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K 10520

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: [phone] Fax: ++81-42-587-7781 MAR 2 3 2012

# 510(k) SUMMARY

#### Submitter's Name/Address

Submitter's Name:

Submitter's Address:

Phone:

Fax:

Establishment Registration Number: Owner/Operator Number:

Tokyo Boeki Medisys Inc. 1-14-21 Higashi-Toyoda, Hino Tokyo 197-0823 [phone] [phone] 3004378324 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<br>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:

Classification Numbers/Class:

اللهرجما (اللانيل) الكان

January 6, 2012

Biolis 12i

Clinical Chemistry Analyzer (with optional ISE Module)

| 75JJE, | Class I |
|--------|----------|
| 75JGS, | Class II |
| 75CEM, | Class II |
| 75CGZ, | Class II |
| 75CFR, | Class II |

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### disys System I

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Ja Phone: [phone] Fax: ++81-42-587-7781

### 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 : K110520

#### Description:

Using photometry, the Biolis 12i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 12i 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 12i is a discrete chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing. It is for vitro diagnostic use only.

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.

The Biolis 12i 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

#### Substantial Equivalence:

Substantial equivalence has been demonstrated between Sirrus (K0421169) running Glucose reagents (K971467) and the Biolis 12i for measuring glucose in serum. These analyzers are calibrated with known concentration calibrator material and both measure specific concentrations using photometry and electrolytes using identical ion selective electrode modules In addition, substantial equivalence has been demonstrated between the Prestige 24i (K040958) and

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1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: [phone] Fax: ++81-42-587-7781

the Biolis 12i with an optional lon Selective Electrode Module for measuring sodium, potassium and chloride in serum. These two analyzers are used to analyze for electrolytes. These analyzers are calibrated with known concentration calibrator material and both utilize lon-Selective Electrodes.

#### Comparison table with Sirrus (Glucose)

| Item | New Device<br>Biolis 12i | Predicate<br>Sirrus(K042169) |
|------------------------|----------------------------------------------------------|-------------------------------------------------------|
| General | | |
| System Principle | Discrete, single line random access, multi-test analysis | Discrete, random access, multi-test analysis |
| Throughput | 90 tests | 240 tests |
| Configuration | Analytical unit, Control unit | Analytical unit, Control unit |
| Measurement modes | Absorbance | Absorbance |
| Detector | Photo-diode | Photo-diode |
| Optical system | Wavelength range of 340 to 800nm | Wavelength range of 340 to 800nm |
| Light source | Tungsten halogen lamp | Tungsten halogen lamp |
| Reaction cuvettes | Plastics, semi disposal | Plastics, semi disposal |
| Path length | 8mm | 8mm |
| Reaction time | Maximum 10min. | Maximum 10min. |
| Incubation temperature | 37°C +/- 0.1°C | 37°C +/- 0.1°C |
| Glucose | | |
| Intended use | Quantitative determination of<br>glucose in serum | Quantitative determination of<br>glucose in serum |
| Method | Photometric endpoint using<br>glucose hexokinase. | Photometric endpoint using<br>glucose |
| Sample type | Serum | Serum, |
| Sample Volume | 2 uL | 3 uL |
| Wavelength | 340 / 405 nm | 340 / 405 nm |
| Reaction type | Endpoint | Endpoint |
| Read Point | Read period: 19 - 20 cycles<br>(30 seconds per cycle) | Read period: 50 - 52 cycles<br>(15 seconds per cycle) |

### Comparison Table with Prestige 24i (ISE)

| Item | New Device<br>Biolis 12i | Predicate<br>Prestige 24i (K040958) |
|-------------------|-------------------------------------------------------------|-------------------------------------------------|
| General | | |
| System Principle | Discrete, single line random<br>access, multi-test analysis | Discrete, random access,<br>multi-test analysis |
| Throughput | 100 tests including ISE tests | 400 tests including ISE tests |
| Configuration | Analytical unit, Control unit | Analytical unit, Control unit |
| Measurement modes | Absorbance | Absorbance |
| Detector | Photo-diode | Photo-diode |
| Optical system | Wavelength range of 340 to | Wavelength range of 340 to |

. ·

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Tokyo Boeki Medisys System Ltd.
1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan
Phone: [phone]

| | 800nm | 800nm |
|------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------|
| Light source | Tungsten halogen lamp | Tungsten halogen lamp |
| Reaction cuvettes | Plastics, semi disposal | Plastics, semi disposal |
| Path length | 8mm | 8mm |
| Reaction time | Maximum 10min. | Maximum 10min. |
| Incubation temperature | 37°C +/- 0.1°C | 37°C +/- 0.1°C |
| ISE | The ISE module is operated on<br>the Biolis 12i integrated system. | The ISE module is operated on<br>the Biolis 24i integrated system |
| Intended use | Quantitative determination of<br>Na, K and Cl | Quantitative determination of<br>Na, K and Cl |
| Method | Ion selective electrode | Ion selective electrode |
| Sample type | Serum | Serum |
| Sample Volume | 60 uL | 60 uL |
| Analysis time | 100 seconds | 100 seconds |

### The validated system is described below.

. :

| Analyzer: | Tokyo Boeki BiOLiS 12i Analyzer with Ion -selective electrode module using<br>direct potentiometry. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Serial numbers are listed on individual study reports |
| Software | Interface software version: 1.70<br>ISE ROM software version: 3.05 |
| Reagent: | Carolina Liquid Chemistries Glucose Reagent, Kit product no. BL-208 (also<br>packaged as AU-208). Lot numbers are listed on individual study reports |
| Calibrator<br>for glucose | Pointe Scientific Chemistry Calibrator<br>product no. C7506-50, lot 11802, exp. March 2014 |
| | 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<br>NIST SRM 965b, Glucose in Frozen Serum. The Pointe Calibrator was<br>assayed eight times over each of four analytical runs against NIST standard<br>levels 3 and 4 which were each assayed in duplicate. The glucose<br>concentration of the Pointe Calibrator was calculated for each run by linear<br>interpolation the NIST assay values and their respective certified values of 118.5<br>mg/dL and 294.5 mg/dL. The mean glucose result of the Pointe Calibrator over<br>the four runs was 185.6 mg/dL. |
| Calibrator<br>for ISE | Calibrator 1 and Calibrator 2<br>Manufacturer: Tokyo Boeki Medisys |
| | Lot numbers are listed on individual study reports |
| | Premarket clearance reference no: K040958 |

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1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: [phone] Fax: ++81-42-587-7781

### Performance Characteristics:

ISE

A correlation analysis between the Prestige 24i and the Biolis 12i yielded the following results:

| | Representative<br>Method | Correlation<br>Coefficient | Slope<br>(Least-Squares) | Y-axis intercept |
|---|--------------------------|----------------------------|--------------------------|------------------|
| 1 | Sodium | 0.9872 | 1.0204 | -3.1903 |
| 2 | Potassium | 0.9992 | 1.0255 | -0.1457 |
| 3 | Chloride | 0.9922 | 0.9736 | 1.8580 |

### The linearity test yielded the following results:

| Linearity | |
|-----------|--------------------------|
| Sodium | 100 - 200 mmol/L (Serum) |
| Potassium | 1 - 10 mmol/L (Serum) |
| Chloride | 70 - 200 mmol/L (Serum) |

### The precision test results:

| | | Item | Sample 1<br>%CV | Sample 2<br>%CV | Sample 3<br>%CV |
|---|---------------------------|-----------|-----------------|-----------------|-----------------|
| 4 | Within Run<br>N=20 | Sodium | 0.85 | 0.61 | 0.93 |
| | | Potassium | 0.90 | 0.91 | 0.94 |
| | | Chloride | 0.79 | 0.83 | 0.69 |
| 5 | Day by<br>Day-Run<br>N=15 | Sodium | 0.4 | 0.4 | 0.3 |
| | | Potassium | 0.8 | 0.9 | 0.4 |
| | | Chloride | 1.0 | 0.7 | 0.4 |

### Interferences

The Interference test yielded the following results:

No significant interference were observed for the substances at the concentration levels as follows

| Substance | Normal | Abnormal |
|-------------|------------|------------|
| Bilirubin F | 19.7 mg/dL | 19.7 mg/dL |
| Bilirubin C | 21 mg/dL | 21 mg/dL |
| Hemoglobin | 488 mg/dL | 488 mg/dL |
| Lipemia | 1000mg/dL | 500 mg/dL |

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1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: [phone] Fax: ++81-42-587-7781

| | Normal | Abnormal |
|--------------------|--------------|--------------|
| Lithium Chloride | 3.20 mmol/L | 3.20 mmol/L |
| Sodium Bromide | 37.60 mmol/L | 37.60 mmol/L |
| Sodium Salicylate | 4.34 mmol/L | 4.34 mmol/L |
| Sodium Thiocyanate | 6.88 mmol/L | 6.88 mmol/L |

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### Conclusion:

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The lon Selective Electrode performance data for Sodium, Potassium and Chloride demonstrates that Biolis 12i is substantially equivalent to the Prestige 24i (K040958).

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1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: [phone] Fax: ++81-42-587-7781

### Glucose Reagent

### Method Comparison

A correlation analysis between the Sirrus and the Biolis 12i yielded the following results:

| Representative<br>Method | Correlation<br>Coefficient | Slope<br>(Least-Squares) | Y-axis intercept |
|--------------------------|----------------------------|--------------------------|------------------|
| GLU | 0.9975 | 1.0447 | -4.845 |

### Precision

The precision test results:

| | Item | Sample 1<br>CV (%) | Sample 2<br>CV (%) | Sample 3<br>CV (%) | |
|---|---------------------|--------------------|--------------------|--------------------|------|
| 1 | Within-run<br>N=20 | GLU | 1.31 | 1.19 | 1.04 |
| 2 | Between-run<br>N=20 | GLU | 0.87 | 0.78 | 0.70 |

#### Linearity

The linearity test yielded the following results:

| Correlation | 0.9997 |
|-------------|-------------------|
| Slope | 0.96 |
| Intercept | -2.66 |
| Range | 25 - 540<br>mg/dL |

### Sensitivity

The minimum detection limit test yielded the following results:

| Minimum Detectable value | 7.83 mg/dL |
|--------------------------|------------|
|--------------------------|------------|

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1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: [phone] Fax: ++81-42-587-7781

# Interferences

- The Interference test yielded the following results: .
No significant interference were observed at the following concentration levels

| | Normal | Abnormal |
|------------|------------|------------|
| Hemoglobin | 500mg/dL | 500mg/dL |
| Bilirubin | 20 mg/dL | 20 mg/dL |
| Lipemia | 1000 mg/dL | 1000 mg/dL |

### Stability Summary

The calibration stability test yielded the following results:

| | Sample 1 | Sample 2 | Sample 3 |
|--------|----------|----------|----------|
| CV (%) | 2.1 | 2.5 | 2.1 |

### Conclusion:

The glucose performance data demonstrates that Biolis 12i is substantially equivalent to Sirrus (K 042169)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around a central emblem. The emblem features a stylized depiction of an eagle or bird-like figure, with flowing lines suggesting wings or feathers.

#### Public Health Service

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

Tokyo Boeki Medisys Inc. c/o James Clinton c/o Quality & Regulatory Consulting, LLC. 5105 Fairoaks Rd. Durham, NC 27712

MAR 2 3 2012

k110520 Re:

Trade Name: BIOLIS 12i Regulation Number: 21 CFR §862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Codes: JGS, CEM, CGZ, CFR, JJE Dated: February 29, 2012 Received: March 6, 2012

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 11 796 tt 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/ResourcesforYou/Industry/default.htm

Sincerely yours,

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): K110520

Device Name: Biolis 12i

Indications for Use:

The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing. It is for vitro diagnostic use only.

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.

The Biolis 12i 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

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

Rute Chube

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

110520 510(k)________________________________________________________________________________________________________________________________________________________________________

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