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.

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

AI/ML Overview

The provided 510(k) summary describes the Biolis 12i, a clinical chemistry analyzer with an optional Ion-Selective Electrode (ISE) module, and its performance for measuring glucose, sodium, potassium, and chloride in serum. The study focuses on demonstrating substantial equivalence to predicate devices (Sirrus for Glucose and Prestige 24i for ISE).

Here's an analysis of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical "acceptance criteria" in the format of a predefined pass/fail threshold. Instead, it presents performance characteristics (correlation, linearity, precision, and interference) and asserts "substantial equivalence" to the predicate devices. The implicit acceptance criterion is that the performance of the Biolis 12i must be comparable or equivalent to the predicate devices.

Performance Metric	Analyte	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Biolis 12i)
Correlation
(vs. Predicate)	Sodium	Comparable to Prestige 24i	0.9872 (Correlation Coefficient)
	Potassium	Comparable to Prestige 24i	0.9992 (Correlation Coefficient)
	Chloride	Comparable to Prestige 24i	0.9922 (Correlation Coefficient)
	Glucose	Comparable to Sirrus	0.9975 (Correlation Coefficient)
Linearity
Range (Serum)	Sodium	Reportable range	100 - 200 mmol/L
	Potassium	Reportable range	1 - 10 mmol/L
	Chloride	Reportable range	70 - 200 mmol/L
	Glucose	Reportable range	25 - 540 mg/dL
Precision
Within Run %CV	Sodium	Low variability	0.85, 0.61, 0.93
	Potassium	Low variability	0.90, 0.91, 0.94
	Chloride	Low variability	0.79, 0.83, 0.69
	Glucose	Low variability	1.31, 1.19, 1.04
Day-by-Day %CV	Sodium	Low variability	0.4, 0.4, 0.3
	Potassium	Low variability	0.8, 0.9, 0.4
	Chloride	Low variability	1.0, 0.7, 0.4
Between-run %CV	Glucose	Low variability	0.87, 0.78, 0.70
Interferences	All Analytes	No significant interference at specified concentrations	No significant interference observed at specified concentrations (Bilirubin, Hemoglobin, Lipemia, Lithium Chloride, Sodium Bromide, Sodium Salicylate, Sodium Thiocyanate)
Sensitivity
Minimum Detectable Value	Glucose	Quantifiable low limit	7.83 mg/dL
Stability
Calibration Stability CV (%)	Glucose	Low variability	2.1, 2.5, 2.1

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not explicitly state the total number of patient samples (serum) used for the correlation, linearity, and interference studies.
- For precision studies:
  - ISE (Sodium, Potassium, Chloride): N=20 for Within Run (repeated measurements of 3 samples), N=15 for Day-by-Day (measurements of 3 samples over 15 days).
  - Glucose: N=20 for Within-run (repeated measurements of 3 samples), N=20 for Between-run (measurements of 3 samples over 20 runs, likely implying 20 days if one run/day).
Data Provenance: The document does not specify the country of origin of the data or explicitly state whether the study was retrospective or prospective. Given that the manufacturer is in Japan, it's possible the studies took place there, but this is not confirmed in the text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Experts: Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by reference methods or predicate devices, not human expert consensus on interpretations. The ground truth for the correlation studies was the measurements obtained from the predicate devices (Prestige 24i for ISE and Sirrus for glucose) and for linearity studies, it would be prepared known concentrations. For calibrator verification, the ground truth for glucose was NIST SRM 965b.
Qualifications: Not applicable in the context of expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This is an IVD device measuring analytes, not making diagnostic interpretations that require human adjudication. The performance is assessed by direct comparison to established methods or known concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This is not applicable. The Biolis 12i is an automated clinical chemistry analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data outputs and making diagnoses. Therefore, an MRMC study and effects on human reader improvement are not relevant to this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, this study essentially represents standalone performance. The Biolis 12i is an automated analyzer. The performance characteristics (correlation, linearity, precision, interference) are measured for the device itself using predefined protocols, without a "human-in-the-loop" interaction for interpretation that would alter its output. The results are quantitative measurements directly from the algorithm/instrument.

7. The Type of Ground Truth Used:

For Correlation Studies: The ground truth was the measurements obtained from the predicate devices (Sirrus for Glucose, Prestige 24i for Na, K, Cl).
For Linearity Studies: The ground truth was based on a range of known concentrations (likely serially diluted or prepared samples).
For Calibrator Verification (Glucose): The ground truth was NIST SRM 965b, Glucose in Frozen Serum, which is a certified reference material.

8. The Sample Size for the Training Set:

Not applicable / Not disclosed. Automated clinical chemistry analyzers typically do not have a "training set" in the machine learning sense. Their operational parameters are often determined by engineering design, chemical principles, and calibration curves established with known standards. The document clarifies how calibrators were verified but does not mention a distinct "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As a traditional in vitro diagnostic device, it does not involve machine learning "training sets" and associated ground truth establishment in the way AI/ML devices do. Its "calibration" is performed using known concentration calibrator materials and validated against reference standards. For instance, the glucose calibrator was verified against NIST SRM 965b.

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 RoadDurham, 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

-1-

{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:

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.

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

-2-

{2}------------------------------------------------

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 DeviceBiolis 12i	PredicateSirrus(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 ofglucose in serum	Quantitative determination ofglucose in serum
Method	Photometric endpoint usingglucose hexokinase.	Photometric endpoint usingglucose
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 DeviceBiolis 12i	PredicatePrestige 24i (K040958)
General
System Principle	Discrete, single line randomaccess, 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 onthe Biolis 12i integrated system.	The ISE module is operated onthe Biolis 24i integrated system
Intended use	Quantitative determination ofNa, K and Cl	Quantitative determination ofNa, 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 usingdirect potentiometry.
	Serial numbers are listed on individual study reports
Software	Interface software version: 1.70ISE ROM software version: 3.05
Reagent:	Carolina Liquid Chemistries Glucose Reagent, Kit product no. BL-208 (alsopackaged as AU-208). Lot numbers are listed on individual study reports
Calibratorfor glucose	Pointe Scientific Chemistry Calibratorproduct 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 theCarolina Liquid Chemistries Glucose Reagent by comparing the calibrator toNIST SRM 965b, Glucose in Frozen Serum. The Pointe Calibrator wasassayed eight times over each of four analytical runs against NIST standardlevels 3 and 4 which were each assayed in duplicate. The glucoseconcentration of the Pointe Calibrator was calculated for each run by linearinterpolation the NIST assay values and their respective certified values of 118.5mg/dL and 294.5 mg/dL. The mean glucose result of the Pointe Calibrator overthe four runs was 185.6 mg/dL.
Calibratorfor ISE	Calibrator 1 and Calibrator 2Manufacturer: Tokyo Boeki Medisys
	Lot numbers are listed on individual study reports
	Premarket clearance reference no: K040958

{4}------------------------------------------------

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:

	RepresentativeMethod	CorrelationCoefficient	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 RunN=20	Sodium	0.85	0.61	0.93
		Potassium	0.90	0.91	0.94
		Chloride	0.79	0.83	0.69
5	Day byDay-RunN=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

{5}------------------------------------------------

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

Conclusion:

: :

: 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

. : :

· . '

{6}------------------------------------------------

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:

RepresentativeMethod	CorrelationCoefficient	Slope(Least-Squares)	Y-axis intercept
GLU	0.9975	1.0447	-4.845

Precision

The precision test results:

	Item	Sample 1CV (%)	Sample 2CV (%)	Sample 3CV (%)
1	Within-runN=20	GLU	1.31	1.19	1.04
2	Between-runN=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 - 540mg/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,

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:

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.

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)________________________________________________________________________________________________________________________________________________________________________

Page 1 of |

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.