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 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 islet cell carcinoma.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tokyo Boeki Medisys Inc. Biolis 24i Clinical Chemistry Analyzer, specifically for glucose measurement:

Acceptance Criteria and Device Performance for Biolis 24i Clinical Chemistry Analyzer (Glucose)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria values for each performance characteristic. Instead, it presents the results of the performance studies and implicitly suggests that these results demonstrated substantial equivalence to the predicate device. For the purpose of this response, I infer the reported performance as the outcome that met the (unspecified) acceptance criteria for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance (Biolis 24i)
Method Comparison (vs. Predicate SYNCHRON CX 7)	Correlation Coefficient (R) close to 1	GLU: 0.999
	Slope (Least-Squares) close to 1	GLU: 0.974
	Y-axis intercept close to 0	GLU: 2.22
Precision (Repeatability)	Low Coefficient of Variation (CV%)	Serum 1: 1.3% Serum 2: 1.3% Serum 3: 1.2% Serum 4: 1.1% Serum 5: 1.5%
Precision (Total Imprecision)	Low Coefficient of Variation (CV%)	Analyzer 2229450610: Control 1: 2.4% Serum Pool 1: 2.5% Serum Pool 2: 2.1% Control 2: 2.3% Analyzer 2227671109: Control 1: 1.9% Serum Pool 1: 2.3% Serum Pool 2: 1.9% Control 2: 2.2%
Linearity	Correlation close to 1	0.9982
	Slope close to 1	0.948
	Intercept close to 0	2.45
	Range of linearity	25 - 500 mg/dL
Sensitivity	Low values for LoB, LoD, LoQ	LoB: 3.64 mg/dL LoD: 5.64 mg/dL LoQ: 10 mg/dL
Interferences	< 10% bias or clinically insignificant interference at stated concentrations	Ascorbic acid: none Bilirubin: -3.3 mg/dL, -3.6% Hemoglobin: -3.6 mg/dL, -3.8% Lipemia: +4 mg/dL, +3.9% Metronidazole: +2.4 mg/dL, +3.1% Tetracycline: none

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

Method Comparison: The document does not explicitly state the total number of samples used for the method comparison (correlation analysis) with the Beckman CX-7.
Precision (Repeatability): 60 replicates for each of 5 serum samples.
Precision (Total Imprecision): 80 replicates for each of 4 samples (2 controls, 2 serum pools) on each of two different analyzers.
Linearity: The sample size for the linearity study is not explicitly stated, but it covered a range of 25 - 500 mg/dL.
Interferences: The sample sizes for the interference study are not explicitly stated, but tests were performed at two glucose concentrations (e.g., 75 mg/dL and 140 mg/dL for Ascorbic acid).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective clinical studies. Given the manufacturer's location (Japan) and the context of typical lab instrument validation, these are likely prospective laboratory studies rather than large-scale clinical trials. The samples used (serum, controls, serum pools) suggest laboratory-generated or purchased materials.

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

This device is a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" for such devices is established by reference methods or validated calibrated materials, not typically by human expert consensus or adjudication on individual cases.

For Method Comparison: The "ground truth" was essentially the measurements obtained from the predicate device, the Beckman CX-7.
For Calibration: The calibrator (Pointe Scientific Chemistry Calibrator) was verified against NIST SRM 965b (Glucose in Frozen Serum), which serves as a highly reliable reference.
No human experts were used to establish the ground truth for the analytical performance of the test set in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth for this type of device is established by reference methods/calibrators, not by human expert adjudication of individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for a standalone clinical chemistry analyzer. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images or data, and the effect of AI assistance on their performance is evaluated. This device provides a quantitative measurement directly.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this entire submission focuses on the standalone performance of the Biolis 24i analyzer as a device for measuring glucose quantitatively. There is no human-in-the-loop component in its measurement principle; it is an automated instrument.

7. The Type of Ground Truth Used

The ground truth used was based on:

Reference measurements from a predicate device (Beckman CX-7) for method comparison studies.
NIST Standard Reference Material (SRM 965b, Glucose in Frozen Serum) for verifying the calibrator used to establish the measurement accuracy.
Known concentrations in control materials and serum pools for precision studies.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development. Clinical chemistry analyzers are typically developed and validated using well-established analytical principles and internal testing, calibration, and verification processes rather than machine learning "training sets" in the way an AI algorithm might have one. The "training" would refer to the calibration of the instrument using known calibrators. The text states:

The calibrator (Pointe Scientific Chemistry Calibrator) was assayed eight times over each of four analytical runs against NIST standard levels 3 and 4, each assayed in duplicate. This process helps "train" or verify the calibration curve for the device.

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

As mentioned above, the "training" in this context refers to the calibration and verification process. The ground truth for the calibrator was established by comparing it to NIST SRM 965b, Glucose in Frozen Serum, which has certified glucose values (118.5 mg/dL and 294.5 mg/dL). This comparison allowed for the verification of the 185 mg/dL glucose set point for the Pointe Calibrator.

Summary

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K103531

Tokyo Boeki Medisys Inc. 1-14-21 Higashi-Toyoda, Hino, Tokyo 191-0051, Japan Phone: +81-42-587-2965 Fax: +81-42-587-7781

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, HinoTokyo 191-0052
Phone:	+81-42-587-2965
Fax:	+81-42-587-7781
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:	clintonjm@earthlink.net

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: +81-42-587-2965 Fax: +81-42-587-7

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:

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 DeviceBiolis 24i	PredicateSYNCHRON 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: +81-42-587-2965

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` Analysis timeRead period: 52 - 54 points(15 seconds per point)	5 min

The validated system is described below.

.. .

Analyzer:	Tokyo Boeki BioLis 24i Analyzer, software revision: 1.26Serial numbers are listed on individual data sheets.
Reagent:	Carolina Liquid Chemistries Glucose Reagent, Kit product no. BL-208 (alsopackaged as AU-208). Lot numbers are listed on individual data sheets.
Applicationparameters:	Sample volume: 3 µLReagent volume: 310 µLWavelengths: 340 / 405 nmReaction type: EndpointRead period: 52 - 54
Calibrator:	Pointe Scientific Chemistry Calibratorproduct no. C7506-50, lot 11802, exp. March 2014Premarket 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 to NISTSRM 965b, Glucose in Frozen Serum. The Pointe Calibrator was assayed eighttimes over each of four analytical runs against NIST standard levels 3 and 4 whichwere each assayed in duplicate. The glucose concentration of the Pointe Calibratorwas calculated for each run by linear interpolation the NIST assay values and theirrespective certified values of 118.5 mg/dL and 294.5 mg/dL. The mean glucoseresult 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: +81-42-587-2965 Fax: +81-42-587-7781

Performance Characteristics

Method Comparison

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

RepresentativeMethod	CorrelationCoefficient	Slope(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: +81-42-587-2965 Fax: +81-42-587-7781

Sensitivity

	mg/dL
LoB	3.64
LoD	5.64
LoQ	10

Interferences

Interferent	InterferentConcentration	GlucoseConcentration	ObservedInterference
Ascorbic acid	30 mg/L	75 mg/dL140 mg/dL	none
Bilirubin	4.8 mg/dL6.4 mg/dL	90 mg/dL146 mg/dL	-3.3 mg/dL-3.6%
Hemoglobin	240 mg/dL160 mg/dL	76 mg/dL139 mg/dL	-3.6 mg/dL-3.8%*
Lipemia(from Intralipid)	600 mg/dL80 mg/dL	72 mg/dL142 mg/dL	+ 4 mg/dL+ 3.9%
Metronidazole	24 mg/L48 mg/L	76 mg/dL139 mg/dL	+ 2.4 mg/dL+ 3.1%
Tetracycline	15 mg/L	76 mg/dL141 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 (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/Resourcesfor You/Industry/default.htm

Sincerely yours,

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:

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

Page 1 of

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.