The Smartest™ Glucowise Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

It is not intended for the diagnosis or screening for diabetes mellitus.

The Smartest™ Glucowise Blood Glucose Monitoring System has the same intended use as previously cleared for the Smartest™ SuperCheck I Blood Glucose Monitoring System (K091815).

The Smartest™ Glucowise Blood Glucose Monitoring System has done a cleaning and disinfection validation test to comply with "Letter to Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA" dated September, 30th, 2010.

For single patient use

Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 1 6267-S is intended to be used by a single person and should not be shared.

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-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 is not changing rapidly).

The Smartest™ Glucowise Test Strips are for use with the Smartest™ Glucowise Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.

The Smartest™ Glucowise Control Solutions are for use with the Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S as a quality control check to verify that the meter and test strips are working together properly.

For multiple patient use

Smartest™ Glucowise MULTI Blood Glucose Monitoring System, Model 6267-M

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-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 diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-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 Smartest™ Glucowise MULTI Test Strips are for use with the Smartest™ Glucowise MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.

The Smartest™ Glucowise MULTI Control Solutions are for use with the Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M as a quality control check to verify that the meter and test strips are working together properly.

Device Description

The Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-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, a glucose test strip is inserted into the top of the device. 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 provided text regarding the Smartest™ Glucowise Blood Glucose Monitoring System, focusing on acceptance criteria, performance, and study details.

Important Note: The provided text is a 510(k) summary for a Special 510(k) submission. A Special 510(k) is used when a modification to an already cleared device does not significantly alter its safety or effectiveness. In this case, the modification was the removal of a "talking feature." Therefore, the submission primarily focuses on demonstrating that this change does not negatively impact the device's original performance, rather than conducting a full de novo performance study for the original device. This means much of the detailed performance data and study specifics (like sample sizes for training/test sets, expert qualifications, etc.) for the glucose measurement function itself are likely contained within the predicate device's (K091815) original submission, which is not included here. This document leverages the previous clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) and the primary modification is the removal of a talking feature, the document does not explicitly state new, specific acceptance criteria for glucose measurement performance. Instead, it asserts that the device's performance remains equivalent to the predicate device (Smartest™ SuperCheck 1, K091815), which was already cleared by the FDA.

Therefore, the "reported device performance" is essentially that the Smartest™ Glucowise system retains the performance characteristics of the Smartest™ SuperCheck 1, as the modification (removing the talking feature) is stated to "not affect the intended use of the device, and it will not significantly affect safety or effectiveness."

To understand the actual numerical acceptance criteria for glucose measurement accuracy, one would need to refer to the original K091815 submission for the predicate device.

Acceptance Criteria (Implied, based on predicate equivalence)	Reported Device Performance (Implied, based on predicate equivalence)
Equivalent intended use as predicate device (K091815)	Intended use remains the same (quantitative glucose measurement in capillary blood).
No significant effect on safety or effectiveness due to voice feature removal.	No significant effect on safety or effectiveness.
Fundamental scientific technology employed remains unchanged.	Fundamental scientific technology employed remains unchanged.
Product sterilization, shelf-life, and biocompatibility unaffected.	Product sterilization, shelf-life, and biocompatibility are equivalent to the predicate.

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

The provided document does not specify a sample size for a test set related to the glucose measurement accuracy for the Smartest™ Glucowise device. This is because the submission is a "Special 510(k)" relying on the equivalence to a previously cleared device where only a non-performance-affecting modification (removal of a talking feature) was made.

The document states: "Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device... meet the design input requirements." This suggests internal testing was done to confirm the removal of the talking feature did not inadvertently introduce new risks or affect existing functionalities. However, no details on test set sizes or data provenance for these specific "verification and validation activities" are provided in the summary.

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

This information is not provided in the document. For a glucose monitoring system, "ground truth" for blood glucose levels is typically established using laboratory reference methods (e.g., YSI glucose analyzer), not expert consensus in the traditional sense of medical imaging or diagnosis. Since this is a Special 510(k), explicit details on expert involvement (beyond internal validation engineers) are not expected for this specific modification.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for studies where human interpretation of data (e.g., medical images) is involved and multiple experts' opinions need to be reconciled. For a blood glucose meter, the "ground truth" is typically a quantitative laboratory measurement.

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

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are generally applicable to interpretive tasks where human readers' performance is being evaluated, often with and without AI assistance. This device is a blood glucose meter, which provides a quantitative reading, not an interpretive one involving human readers for diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This document does not describe a standalone performance study in the context of an "algorithm only" as typically discussed for AI/ML devices. The device is a standalone glucose measurement system. Its performance is evaluated by comparing its readings to a reference method, not by assessing an algorithm's performance in isolation from the hardware.

The entire device is the "standalone" measurement system, and its performance for glucose measurement would have been established and cleared in the predicate device's submission (K091815). The current submission leverages that prior clearance.

7. Type of Ground Truth Used

Based on the nature of a blood glucose monitoring system, the ground truth for glucose measurements would typically be established using a laboratory reference method (e.g., YSI glucose analyzer) that provides highly accurate and precise glucose concentration values. This document does not explicitly state the ground truth method, but it is implied by the "quantitative measurement of glucose."

8. Sample Size for the Training Set

This information is not provided in the document. The device is a traditional electrochemical blood glucose meter, not a machine learning model that requires a "training set" in the common understanding of AI/ML. Its operational parameters are determined through calibration and manufacturing processes, not by training on a large dataset in the AI sense.

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

As noted above, the concept of a "training set" as it applies to AI/ML devices is not relevant here. The device uses established chemical principles to measure glucose. Therefore, there is no "ground truth for the training set" to be established in the context of machine learning.

Summary

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510 (k) Summary

MAY 0 2 2013

. .

1. Submitter Information

上,

Company name	Biotest Medical Corporation
Contact person	Amanda Chiang
Address	No. 3-2, Chien-kuo road, TEPZ Tantzu, 427, Taichung, Taiwan
Phone	886-4-2532-6668
FAX	886-4-2532-6593
E-mail	amanda@mail.biotestsystems.com
Date Prepared	May 2nd, 2013

2. Name of Device

. .

Trade/Proprietary Name	Smartest™ Glucowise Blood Glucose Monitoring System, Model6267-S
	Smartest™ Glucowise MULTI Blood Glucose Monitoring System,Model 6267-M
Common Names	In Vitro Diagnostic Glucose Test System
Product Code	NBW, System, Test, Blood Glucose, Over-the-Counter
	CGA, Glucose Oxidase, Glucose
	JJX, Single (Specified) Analyte Controls
Classification Panel	Clinical Chemistry
Device Class	Class II
C.F.R. Section	862.1345

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K122525

3. Predicate Device

Trade/Proprietary	Name Smartest™ SuperCheck 1 Blood Glucose Monitoring System,(Model 6268)
Common/Usual Name	In Vitro Diagnostic Glucose Test System
Submitter	Biotest Medical Corporation
510 (k) Number	K091815

4. Device Description

The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

5. Intended Use/Indications for Use

It is not intended for the diagnosis or screening for diabetes mellitus.

The Smartest™ Glucowise Blood Glucose Monitoring System has the same intended use as previously cleared for the Smartest™ SuperCheck I Blood Glucose Monitoring System (K091815).

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For single patient use

Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S

For multiple patient use

Smartest™ Glucowise MULTI Blood Glucose Monitoring System, Model 6267-M

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should

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K122525

be done only during steady - state times (when glucose is not changing rapidly).

6. Comparison to Predicate Device

For the proposed Smartest™ Glucowise device, the modification from the cleared Smartest™ SuperCheck 1 (K091815) is the removal of talking feature.

. Voice feature change from talking to non-talking

This modification involves the removal of speaker component as well as talking software module from Smartest™ SuperCheck 1 (Model 6268). This modification was made due to customer's input and marketing consideration. Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M), in all functions and specifications are exactly same as Smartest™ SuperCheck 1 (Model 6268) except for the talking feature. The modification in talking feature will not affect the intended use of the device, and it will not significantly affect safety or effectiveness.

The modification maintain the integrity of the Smartest Glucowise device (Model 6267-S, 6267-M) as described in the original clearance in terms of the intended use of the device (i.e., the quantitative measurement of glucose in capillary blood), and the fundamental scientific technology employed.

The predicate device and candidate device have same appearance. Product sterilization, shelf-life, and biocompatibility are unaffected by the modifications and are equivalent to the legally marketed Smartest™ SuperCheck 1 (K091815).

For the reasons outlined above, the Smartest Glucowise device (Model 6267-S, 6267-M) is eligible for Special 510(k) in accordance with FDA guidance. '

" Center for Devices and Radiological Health. The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance. March 20, 1998.

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7. Performance Studies

Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device, Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M), meet the design input requirements.

8. Conclusion

Modifications to the cleared device, Smartest™ SuperCheck 1 (K091815), include voice feature change from talking to non-talking. The modifications maintain the integrity of the Smartest™ SuperCheck 1 (K091815) as described in the original clearance in terms of the intended use of the device (i.e., the quantitative measurement of glucose in capillary blood), and the fundamental scientific technology employed. For the reasons outlined above, the Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M) is eligible for Special 510(k) in accordance with FDA guidance.

In summary, the Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M) described in this submission is substantially equivalent to the predicate device.

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

Public Health Service

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

May 2, 2013

Biotest Medical Corporation C/O Ms. Amanda Chiang NO.3 - 2 CHIEN-KUO ROAD, TEPZ TANTZU TAICHUNG, TAIWAN 42760 TW

Re: K122525

Trade/Device Name: Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S Smartest™ Glucowise MULTI Blood Glucose Monitoring System, Model 6267-M Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX

Dated: April 03, 2013 Received: April 04, 2013

Dear Ms. Chiang:

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. Ilsting 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 Part 801); 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 regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Carol C. Benson -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 Form

510(k) Number (if known): K122525

Device Name: Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S Indications for Use:

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used by a single person and should not be shared.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use x (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 Diagnostics and Radiological Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K122525

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Indications for Use Form

510(k) Number (if known): K122525

Device Name: Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M

Indications for Use:

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended for testing outside the body (in virro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The Smartest™ Glucowise MULTI Control Solutions are for use with the Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M as a quality control check to verify that he meter and test strips are working together properly.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _x (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 Diagnostics and Radiological Health (OIR)

Katherine /Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K122525

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.