Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard photometric and potentiometric measurement techniques and performance metrics like correlation, linearity, and precision. There is no mention of AI, ML, or related concepts like training/test sets, image processing, or complex algorithms beyond basic data analysis.

Therapeutic

No
This device is an in-vitro diagnostic (IVD) device used for measuring chemical components in serum. It provides information for diagnosis and treatment, but it does not directly perform therapy or treatment.

Diagnostic

Yes.

The device is intended "for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use." The results of these measurements (sodium, potassium, chloride, and glucose) are explicitly stated to be "used in the diagnosis and treatment" of various conditions, such as "diseases involving electrolyte imbalance" and "carbohydrate metabolism disorders including diabetes mellitus." This directly indicates its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "discrete photometric chemistry analyzer with ion-selective electrode (ISE)" and measures concentrations using photometry and indirect potentiometry, which are hardware-based methods.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "It is for vitro diagnostic use only."
Intended Use: The device is intended for the "in-vitro, spectrophotometric determination of general chemistry assays for clinical use." This means it analyzes samples taken from the body (in vitro) to provide information for clinical diagnosis and treatment.
Measurements: It measures substances (sodium, potassium, chloride, and glucose) in biological samples (serum) to aid in the diagnosis and treatment of various diseases and conditions.
Clinical Use: The intended use and the specific measurements (electrolyte balance, carbohydrate metabolism disorders) are directly related to clinical diagnosis and patient care.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 Ion 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

Product codes (comma separated list FDA assigned to the subject device)

JJE, JGS, CEM, CGZ, CFR

Device 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 Ion-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ISE Performance:

Correlation Analysis (Prestige 24i vs. Biolis 12i):
- Sodium: Correlation Coefficient 0.9872, Slope 1.0204, Y-axis intercept -3.1903
- Potassium: Correlation Coefficient 0.9992, Slope 1.0255, Y-axis intercept -0.1457
- Chloride: Correlation Coefficient 0.9922, Slope 0.9736, Y-axis intercept 1.8580
Linearity Test:
- Sodium: 100 - 200 mmol/L (Serum)
- Potassium: 1 - 10 mmol/L (Serum)
- Chloride: 70 - 200 mmol/L (Serum)
Precision Test (N=unknown for Day by Day-Run):
- Within Run (N=20):
  - Sodium: Sample 1 0.85%CV, Sample 2 0.61%CV, Sample 3 0.93%CV
  - Potassium: Sample 1 0.90%CV, Sample 2 0.91%CV, Sample 3 0.94%CV
  - Chloride: Sample 1 0.79%CV, Sample 2 0.83%CV, Sample 3 0.69%CV
- Day by Day-Run (N=15):
  - Sodium: Sample 1 0.4%CV, Sample 2 0.4%CV, Sample 3 0.3%CV
  - Potassium: Sample 1 0.8%CV, Sample 2 0.9%CV, Sample 3 0.4%CV
  - Chloride: Sample 1 1.0%CV, Sample 2 0.7%CV, Sample 3 0.4%CV
Interference Test: No significant interference observed for Bilirubin F (19.7 mg/dL), Bilirubin C (21 mg/dL), Hemoglobin (488 mg/dL), Lipemia (1000 mg/dL normal, 500 mg/dL abnormal), Lithium Chloride (3.20 mmol/L), Sodium Bromide (37.60 mmol/L), Sodium Salicylate (4.34 mmol/L), Sodium Thiocyanate (6.88 mmol/L).

Glucose Reagent Performance:

Method Comparison (Sirrus vs. Biolis 12i):
- GLU: Correlation Coefficient 0.9975, Slope 1.0447, Y-axis intercept -4.845
Precision (N=20 for both):
- Within-run: GLU Sample 1 1.31%CV, Sample 2 1.19%CV, Sample 3 1.04%CV
- Between-run: GLU Sample 1 0.87%CV, Sample 2 0.78%CV, Sample 3 0.70%CV
Linearity Test:
- Correlation: 0.9997
- Slope: 0.96
- Intercept: -2.66
- Range: 25 - 540 mg/dL
Sensitivity: Minimum Detectable value 7.83 mg/dL
Interferences: No significant interference observed for Hemoglobin (500mg/dL), Bilirubin (20 mg/dL), Lipemia (1000 mg/dL).
Stability Summary (Calibration Stability): Sample 1 CV (%) 2.1, Sample 2 CV (%) 2.5, Sample 3 CV (%) 2.1

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" for Correlation Coefficients, Slope, Y-intercept, %CV, Linearity ranges, and Minimum Detectable value for Glucose.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K0421169, K040958

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K971467, K070207

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
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.(b)
Classification. Class II.

Summary

0

K 10520

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: +81-42-587-2965 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 +81-42-532-2771 +81-42-532-2772 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
Durham, NC 27712-2078
Phone:	919-247-0479
Fax:	919-287-2551
E-mail address:	clintonim@earthlink.net

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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1

disys System I

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Ja Phone: +81-42-587-2965 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: +81-42-587-2965 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
Biolis 12i | Predicate
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
glucose in serum | Quantitative determination of
glucose in serum |
| Method | Photometric endpoint using
glucose hexokinase. | Photometric endpoint using
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
(30 seconds per cycle) | Read period: 50 - 52 cycles
(15 seconds per cycle) |

Comparison Table with Prestige 24i (ISE)

| Item | New Device
Biolis 12i | Predicate
Prestige 24i (K040958) |
|-------------------|-------------------------------------------------------------|-------------------------------------------------|
| General | | |
| System Principle | Discrete, single line random
access, multi-test analysis | Discrete, random access,
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 |

. ·

3

Tokyo Boeki Medisys System Ltd.
1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan
Phone: +81-42-587-2965

	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
the Biolis 12i integrated system.	The ISE module is operated on
the Biolis 24i integrated system
Intended use	Quantitative determination of
Na, K and Cl	Quantitative determination of
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
direct potentiometry. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Serial numbers are listed on individual study reports |
| Software | Interface software version: 1.70
ISE ROM software version: 3.05 |
| Reagent: | Carolina Liquid Chemistries Glucose Reagent, Kit product no. BL-208 (also
packaged as AU-208). Lot numbers are listed on individual study reports |
| Calibrator
for glucose | Pointe Scientific Chemistry Calibrator
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
Carolina Liquid Chemistries Glucose Reagent by comparing the calibrator to
NIST SRM 965b, Glucose in Frozen Serum. The Pointe Calibrator was
assayed eight times over each of four analytical runs against NIST standard
levels 3 and 4 which were each assayed in duplicate. The glucose
concentration of the Pointe Calibrator was calculated for each run by linear
interpolation the NIST assay values and their respective certified values of 118.5
mg/dL and 294.5 mg/dL. The mean glucose result of the Pointe Calibrator over
the four runs was 185.6 mg/dL. |
| Calibrator
for ISE | Calibrator 1 and Calibrator 2
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: +81-42-587-2965 Fax: ++81-42-587-7781

Performance Characteristics:

ISE

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

| | Representative
Method | Correlation
Coefficient | Slope
(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
%CV | Sample 2
%CV | Sample 3
%CV |
|---|---------------------------|-----------|-----------------|-----------------|-----------------|
| 4 | Within Run
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
Day-Run
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: +81-42-587-2965 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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:

: :

:

.

: 上一篇:

. . . . .

:

.

. '

:

.

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

:

1. 1

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:

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. : :

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1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: +81-42-587-2965 Fax: ++81-42-587-7781

Glucose Reagent

Method Comparison

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

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

Precision

The precision test results:

| | Item | Sample 1
CV (%) | Sample 2
CV (%) | Sample 3
CV (%) | |
|---|---------------------|--------------------|--------------------|--------------------|------|
| 1 | Within-run
N=20 | GLU | 1.31 | 1.19 | 1.04 |
| 2 | Between-run
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
mg/dL

Sensitivity

The minimum detection limit test yielded the following results:

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

7

1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0052, Japan Phone: +81-42-587-2965 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)

8

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).

9

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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or (301) 796-5680 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

10

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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