The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.

The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.

The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).

The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.

The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.

Device Description

The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.

The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the SuperCheck Plus Blood Glucose Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are not explicitly stated in a single consolidated table in the document, but rather described in the text, referencing ISO 15197 for precision and generally implying agreement with a reference method (YSI 2300) for overall system accuracy. The document states that the system "met the acceptance criteria" without detailing the specific criteria for system accuracy (e.g., percentage within a certain range). For precision, ISO 15197 is mentioned, which typically has performance targets based on CV (Coefficient of Variation) or absolute differences. I will infer based on the stated performance.

Acceptance Criteria	Reported Device Performance	Study Type
Precision
Repeatability Precision (within-run)
Glucose < 100 mg/dL: CV ≤ 7%	CV values were not more than 7%	Precision/Reproducibility
Glucose ≥ 100 mg/dL: CV < 5%	CV values were less than 5%	Precision/Reproducibility
Intermediate Precision (total precision)
Across 3 control levels: CV < 5%	CV values were less than 5%	Precision/Reproducibility
Linearity/Reportable Range
Correlation with reference method (r)	r = 0.9998 compared to YSI analyzer	Linearity/Assay Reportable Range
Measuring range	20-600 mg/dL (Device claims this range)	Linearity/Assay Reportable Range
Operating Temperature	10-40°C (50-104°F)	Study confirmed operation in this range
Operating Humidity	20-80% RH (non-condensing)	Study confirmed operation in this range
Interfering Substances (Analytical Specificity)
Glucose < 100 mg/dL: average difference ≤ 10 mg/dL	Met this criterion for listed substances	Analytical Specificity
Glucose ≥ 100 mg/dL: average difference ≤ 10%	Met this criterion for listed substances	Analytical Specificity
Hematocrit Range	No significant effect from 20-60%	Hematocrit Study
Altitude	No significant effect up to 10,744 ft	Altitude Study
Sample Volume	≥0.7µL produces accurate results (error message for insufficient sample volume of 0.7µL implies accuracy at or above this)	Sample Volume Study
Meter Reliability	All results were within the criteria after challenge (mechanical resistance, vibration, temp/humidity)	Meter Reliability Study
EMC and Electrical Safety	Conforms to IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1 and IEC/EN 61326-2-6 standards	EMC and Electrical Safety Study
Cleaning & Disinfection (Robustness for Meter)	No change in performance or external materials after simulated 3 years of use	Infection Control Studies
Disinfection Efficacy	Complete inactivation of Hepatitis B (HBV) with specified disinfectant	Infection Control Studies
System Accuracy (compared to YSI 2300)	"met the acceptance criteria"	System Accuracy Study
User Performance Study (Accuracy by Lay Users)	"met the acceptance criteria"	User Performance Study
User Performance Study (Ease of Use)	"easy to use for participants"	User Performance Study

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

Precision/Reproducibility (Test Set):
- Repeatability Precision: 5 whole blood concentrations were tested. The number of replicates per concentration is not specified, but typically this involves multiple measurements (e.g., 10-20 replicates). The document doesn't specify if the samples were from a particular country. It's an in-vitro lab study.
- Intermediate Precision: 3 levels of control solutions, 3 lots of test strips, and 10 meters were tested for 10 days. This is an in-vitro lab study.
Linearity (Test Set): 11 concentration levels of capillary whole blood samples (spiked). No specific provenance mentioned, assumed to be laboratory-prepared samples.
Operating Temperature and Humidity Study: Not specified, assumed to be laboratory test samples.
Analytical Specificity: Not specified, assumed to be laboratory test samples.
Hematocrit Study: 9 hematocrit levels at 3 spiked target glucose concentrations. Not specified, assumed to be laboratory test samples.
Altitude Study: Venous blood samples spiked to 3 glucose concentrations. Performed at 33 ft and 10,744 ft. Not specified, assumed to be laboratory test samples.
Sample Volume Study: Blood samples spiked to 3 glucose concentrations, tested from 0.5µL to 3.0µL. Not specified, assumed to be laboratory test samples.
System Accuracy Study (Clinical Test Set): A total of 151 subjects were recruited. The document does not specify the country of origin, but it is a "clinical" study, implying prospective participant recruitment.
User Performance Study (Clinical Test Set): 129 participants. The document implies these were lay users who could read English, suggesting a prospective recruitment in an English-speaking country, but no specific country is mentioned.

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

For the System Accuracy Study, the ground truth was established by a reference method, the YSI 2300 glucose analyzer. This is a highly accurate laboratory instrument, and its operation would typically be managed by trained laboratory technicians or clinical chemists. No "experts" in the sense of clinicians or radiologists are involved in establishing this type of ground truth.
For the User Performance Study, the ground truth for comparison was also likely the YSI 2300 or another laboratory reference method, against which the lay user's results from the device were compared. The "experts" here would be the lab personnel operating the reference method.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for glucose measurements is typically established by objective laboratory reference methods (like the YSI 2300), not through expert consensus or adjudication in the way medical imaging diagnosis might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically done for diagnostic imaging devices where human readers interpret images, sometimes with and without AI assistance, to measure the change in diagnostic accuracy. This document describes a blood glucose monitoring system, which is a quantitative measurement device, not an imaging device. The "User Performance Study" evaluates lay users testing themselves, which is a form of human-in-the-loop performance, but it's not an MRMC study comparing AI vs. no AI assistance for diagnosis.

6. Standalone Performance

Yes, the analytical performance studies (precision, linearity, specificity, hematocrit, altitude, sample volume, meter reliability, EMC/electrical safety) are all forms of standalone performance of the device, without human-in-the-loop interpretation being the primary focus. The "System Accuracy Study" also represents the standalone analytical performance of the device when operated under controlled clinical conditions, comparing its results directly to a gold standard, without focusing on the impact of user interaction beyond the collection and application of the sample.

7. Type of Ground Truth Used

For most analytical performance studies (precision, linearity, analytical specificity, hematocrit, altitude, system accuracy): Reference method measurements, specifically the YSI 2300 glucose analyzer.
For meter reliability and EMC/electrical safety: Adherence to engineering specifications and relevant ISO/IEC standards.
For infection control: Disinfection efficacy testing against a specific pathogen (HBV) and robustness testing of materials.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a blood glucose meter, which typically operates on electrochemistry principles, not an AI or machine learning algorithm that requires a training set. If there were any internal calibrations or algorithms developed during the device's design, the data used for those would be part of internal R&D and not typically disclosed as a "training set" in this type of regulatory document.

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

As no training set (in the AI/ML sense) is mentioned or implied for this type of device, this question is not strictly applicable. The device's operational parameters would be based on underlying physical and chemical principles, calibrated using known glucose concentrations and validated against reference methods, rather than "trained" on a dataset with established ground truth.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2015

BIOTEST MEDICAL CORP. YUHUA CHEN NO.3-2, CHIEN-KUO ROAD, TEPZ, TANTZU, 427 TAICHUNG, TAIWAN

Re: K141351

Trade/Device Name: SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S), SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: May 20, 2014 Received: May 22, 2014

Dear Yuhua Chen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141351

Device Name

SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)

Indications for Use (Describe)

The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingettips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K141351

Device Name

SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S)

Indications for Use (Describe)

The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.

Type of Use (Select one or both, as applicable)

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

(Per 21 CFR 807.92)

1. Submitter Information C

Company Name	Biotest Medical Corporation
Address	No. 3-2 , Chien-kuo road, TEPZ Tantzu, 427Taichung, Taiwan
Contact Person	Yuhua Chen
Phone	886-4-2532-6668
Fax	886-4-2532-6593
Email	yuhuachen@mail.biotestsystems.com
Date Prepared	May 14, 2015

1. Device Name Proprietary Name
  Common Name Classification Number

Classification Panel Product Code Regulation Number

1. Predicate Device Proprietary Name Common Name Manufacturer 510(k) Number
  SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) Blood Glucose Test System System, Test, Blood Glucose, Over the Counter Chemistry NBW, LFR, JJX 862.1345

ACCU-CHEK Performa System Blood Glucose Test System Roche Diagnostics Corporation K070585

1. Device Description
  The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.

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5. Intended Use

For single patient use

SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S)

The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of qlucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model 5228-S) is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.

For multiple patient use SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)

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SuperCheck Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.

Similarities
ltem	SuperCheck Plus Blood Glucose	ACCU-CHEK Performa
	Monitoring System(Model	System (Predicate device)
	5228-S)
	SuperCheck Plus Multi Blood
	Glucose Monitoring System
	(Model 5228-M)
	(Proposed devices)
Enzyme	FAD- glucose dehydrogenase	Glucose dehydrogenase with
		nitrosoaniline mediator
Measurement	Same	Amperometric method
principle
Sample type	Same	Fresh capillary whole blood
		Venous whole blood
Power	Same	Two 1.5V AAA alkaline
		batteries

6. Comparison to Predicate Device

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Glucose units	Same	Either mg/dL or mmol/L
Strip vial open time	Same	90 days
Test time	Same	5 seconds
Memory	Same	500 measurements with day and time
PC link	Same	Yes
Strip storage condition	2~30℃ (35.6-86°F)/20-80%RH	2~30℃(35.6-86°F)


Differences
Weight	72g	62g
Dimensions	100mm(L)x50mm(W)x20mm(H)	93mm(L)x52mm(W)x22mm(H)
Test volume	0.7µL	0.6µL
Test Range	20-600 mg/dL	10-600 mg/dL
Operating condition	10~40℃ (50-104°F)	6~44℃(39.2-111.2°F)
Operating condition	20~80% RH (non-condensing)	10~90% RH
Alternate site capability	Forearm	Palm, forearm, upper arm, thigh, and calf
Hematocrit range	20-60%	10-70%
Coding	No	Yes (A Code Key is provided with each box of test strips to calibrate the meter for that strip lot.)

1. Non-Clinical Performance Characteristics
  A brief description of analytical performance for these studies listed below is included in this submission.
a. Precision/Reproducibility
Precision/Reproducibility evaluations were conducted by performing repeatability precision (within-run precision) and intermediate precision (total precision) based on ISO 15197. Repeatability precision was performed on 5 whole blood concentrations (30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL). For glucose concentration was less than 100 mg/dL, the test results of CV values were not more than 7%. For glucose concentration was more than or

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equal to 100mg/dL, the test results of CV values were less than 5%. Intermediate precision was performed on 3 levels of control solutions (30-50mg/dL, 96-144mg/dL and 280-420mg/dL) with 3 lots of test strips and 10 meters for 10 days. The test results of CV values were less than 5%.

b. Linearity/assay reportable range

The linearity study was performed using capillary whole blood samples. The capillary samples were spiked to 11 concentration levels from 20-600 mg/dL. Linear regression showed a correlation of r-0.9998 compared to the reference method (YSI analyzer) over the range 21 mg/dL to 592 mg/dL.

The measuring range of the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems is 20-600 mg/dL.

c. Operating Temperature and Humidity Study

The study confirmed the operation of the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring System for temperature range of 10-40°C(50-104°F) and the relative humidity range of 20-80%, noncondensing.

d. Analytical specificity

Nine endogenous substances and thirteen exogenous substances were analyzed at two concentrations of glucose and interferent according to NCCLS EP 7. For glucose concentrations is less than 100mg/dL, the average difference between the tested and the control sample is within 10 mg/dL. For glucose concentrations is more than or equal to 100 mg/dL, the average difference between the tested and the control sample is within 10%. Results are presented in the table below:

Interfering substances	Highest concentration at whichno interference is observed
Endogenous substances
Billrubin	20.8 mg/dL
Cholesterol	648.1 mg/dL
Creatinine	5.95 mg/dL
Fructose	30 mg/dL

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Galactose	60 mg/dL
Glutathione	23.5 mg/dL
Glyceryl Tributyrate	3039.3 mg/dL
Hemoglobin	20 g/dL
Uric Acid	9.5 mg/dL
Exogenous substances
Acetaminophen	20 mg/dL
Ascorbic Acid	4.5 mg/dL
Dopamine	1.25 mg/dL
Gentistic acid	6.75 mg/dL
Ibuprofen	50 mg/dL
L-Dopa	1.9 mg/dL
Maltose	1000 mg/dL
Methyl Dopa	1.5 mg/dL
Pralidoxime Iodide(PAM)	62.5 mg/dL
Salicylate	115.5 mg/dL
Tolazamide	3.8 mg/dL
Tolbutamide	64 mg/dL
Xylose	6.3 mg/dL

The accuracy study of EDTA anticoagulated whole blood samples used with SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring System compared to results obtained using a capillary sample collected in heparin with a reference method (YSI glucose analyzer) were evaluated. The result of the study was shown that SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring System produce accurate glucose results when the blood samples are collected in EDTA tube.

e. Hematocrit Study
Nine hematocrit levels of 20, 25, 30, 35, 42, 45, 50, 55 and 60% at 3 spiked target glucose concentrations were evaluated. The study showed no significant hematocrit effect from 20%-60% for samples with concentration levels over dynamic range (20-600 mg/dL).
f. Altitude Study
Venous blood samples were spiked to 3 glucose concentration (30-50 mg/dL, 96-144 mg/dL, 280-420 mg/dL). The samples were performed at 33 ft and 10,744 ft. Values were compared to the YSI 2300 (reference

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method). The results demonstrated that altitudes up to 10,744 ft have no significant effect on blood glucose measurement from the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems.

g. Sample volume study

The blood volume test was performed from 0.5µl to 3.0ul by using the blood samples spiked to produce 3 glucose concentrations (30-50 mg/dL, 96-144 mg/dL, 280-420 mg/dL) for verifying the performance of test strip.

The results showed that error message was displayed for insufficient sample volume of 0.7ul; therefore the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems claim that sample volume of ≥0.7ul produces accurate blood glucose results.

h. Meter reliability study

The reliability test was performed before and after challenge including mechanical resistance to drop and vibration and protection against exposure to temperature and humidity levels. All results were within the criteria. It demonstrates that SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) meters produced accurate results within its claimed temperature and humidity limits.

i. EMC and electrical safety study

SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems by performing Electromagnetic Interference and Safety Test to verify the product conform IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1 and IEC/EN 61326-2-6 standards. All the results revealed the system was complied with the above related standards.

Infection control studies i.

The systems are intended for single-patient use (SuperCheck Plus (5228-S)) and multiple-patient use (SuperCheck Plus Multi (5228-M)). Cleaning and disinfection can be accomplished by wiping the meter with Clorox® Germicidal Wipes (EPA Reg. No. 67619-12). The robustness study was conducted and the results demonstrated that there was no

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change in performance or in the external materials of the meter after 10,950 cleaning and disinfection cycles to simulate 3 years of use for multiple-patient use and after 5475 cleaning cycle and 156 disinfection cycles to simulate 3 years of use for single-patient use.

Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B (HBV) with chosen disinfectant, HEALTHCARETM Bleach Germicidal Wipes by the Clorox Company (EPA registered # 67619-12).

8. Clinical Performance Characteristics

a. System Accuracy Study
The accuracy study of SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems was compared to YSI 2300 (reference method). A total of 151 subjects were recruited. The study result demonstrates that the accuracy of SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems met the acceptance criteria.

b. User Performance Study

The study was performed with 129 participants to demonstrate the accuracy of the SuperCheck Plus (Model 5228-S) Blood Glucose Monitoring System. Participants, who were able to read the User's Manual in English, were instructed to read the manual and perform testing on the finger and the forearm. The study results met the acceptance criteria and according to the results of questionnaire, SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems are easy to use for participants.

9. Conclusion

Laboratory testing and clinical testing results of SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) and SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) demonstrated satisfactory and support their Indications for Use. It also demonstrates that SuperCheck Plus (Model 5228-S) and SuperCheck Plus Multi (Model 5228-M) are substantial equivalence to the predicate.

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.