The TD-4268 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.

The TD-4268 Blood Glucose Monitoring System 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates.

The TD-4268 Blood Glucose Test Strips are for use with the TD-4268 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

The TD-4268 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4268 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus.

Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.

The system is only used with single-use, auto-disabling lancing devices.

The TD-4268 Multi Blood Glucose Test Strips are for use with the TD-4268 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.

Device Description

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

AI/ML Overview

This 510(k) summary (K120042) for the TD-4268 Blood Glucose Monitoring System and TD-4268 Multi Blood Glucose Monitoring System does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria beyond a statement of substantial equivalence to a predicate device.

Instead, the submission relies on demonstrating that the new device has "the same performance characteristics as the predicate device" (TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System, K101635) and that software verification and validation confirmed its performance, safety, and effectiveness are equivalent to the predicate.

Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria are not detailed in this 510(k) summary, a table cannot be constructed with explicit criteria and reported performance. The document generally states:

Acceptance Criteria	Reported Device Performance
Implied: Equivalent performance to predicate device (TD-4239 Blood Glucose Monitoring System)	"TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." "A comparison of system accuracy performance demonstrated that the TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent."
Implied: Performance, safety, and effectiveness	"Software verification and validation testing confirmed that the performance, safety and effectiveness of the TD-4268 Blood Glucose Monitoring System /TD-4268 Multi Blood Glucose Monitoring System are equivalent to the predicate device."

Acceptance Criteria

Reported Device Performance

Implied: Equivalent performance to predicate device (TD-4239 Blood Glucose Monitoring System)

"TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." "A comparison of system accuracy performance demonstrated that the TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent."

Implied: Performance, safety, and effectiveness

"Software verification and validation testing confirmed that the performance, safety and effectiveness of the TD-4268 Blood Glucose Monitoring System /TD-4268 Multi Blood Glucose Monitoring System are equivalent to the predicate device."

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

Sample Size for Test Set: Not explicitly stated in this document. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with a new sample size.
Data Provenance: Not explicitly stated. Given that it's a submission from Taiwan, the data could originate from there, but this is not confirmed. The document does not specify if the data is retrospective or prospective.

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

Number of Experts: Not applicable or not specified. Since the submission focuses on substantial equivalence and mentions "software verification and validation testing" rather than a clinical study with human interpretation of results, there's no indication of experts establishing a ground truth in this context.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. There is no mention of a formal adjudication process for a test set in this summary.

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 to this device. The TD-4268 is a blood glucose monitoring system, an in vitro diagnostic device that measures glucose levels. It is not an AI-assisted diagnostic imaging device requiring human reader interpretation, so an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This is not applicable in the context of an AI algorithm. However, for a blood glucose meter, the "standalone" performance would typically refer to the device's accuracy in measuring glucose levels independently. The document states that the system's accuracy performance was compared to the predicate device to demonstrate substantial equivalence, implying its standalone measurement capability was assessed.

7. The Type of Ground Truth Used

For blood glucose monitoring systems, the ground truth is typically established by reference laboratory methods (e.g., YSI analyzer) for glucose measurement. While not explicitly detailed in this summary, it's the standard practice for such devices to compare their readings against a highly accurate laboratory method. The document mentions "system accuracy performance," which would inherently involve comparison to a gold standard.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable or not specified. This document pertains to a blood glucose meter, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" here would refer to the device's design and calibration, not an AI model.

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

How Ground Truth for Training Set Was Established: Not applicable. As mentioned, this is not an AI algorithm requiring a training set in the machine learning context. The calibration and design of the blood glucose meter would rely on established chemical and electrical engineering principles, with accuracy validated against reference methods.

In summary, this 510(k) submission primarily demonstrates substantial equivalence to a previously cleared predicate device (K101635) by confirming similar operating principles, fundamental technology, circuit design, materials, shelf life, packaging, and manufacturing processes, along with confirmed performance characteristics through "software verification and validation testing." It does not present a detailed, de novo study with explicit acceptance criteria and corresponding performance data as might be expected for novel devices or AI algorithms.

Summary

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K120042

MAY 22 2012

Section 11. 510(k) Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

1. Submitter's Identification:
  TaiDoc Technology Corporation

3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan

Correspondent: Mciru Li Regulatory Affairs Specialist Tel: +886-2-6625-8188 #6134 Fax: +886-2-6625-0288 Email: limeiru@taidoc.com.tw

Prepared date: January 02, 2012

1. Device name:
  D.

Proprietary name: TD-4268 Blood Glucose Monitoring System and TD-4268 Multi Blood Glucose Monitoring System

Regulatory information:

Regulation section: 21 CFR 862.1345 Glucose Test System A.
B. Classification: Class II

LFR, Glucose Dehydrogenase, Glucose ். Product Code:

NBW, System, Test, Blood Glucose, Over The Counter Panel: Clinical Chemistry (75)

11-1

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3. Intended Use:

For single use device

The TD-4268 Blood Glucose Test Strips are for use with the TD-4268 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

For multiple patient use device

Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.

The system is only used with single-use, auto-disabling lancing devices.

The TD-4268 Multi Blood Glucose Test Strips are for use with the TD-4268 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.

4. Device Description:

1. Substantial Equivalence Information:
  11-2

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Predicate device name: TD-4239 Blood Glucose Monitoring System and A. TD-4239 Multi Blood Glucose Monitoring System
B. Predicate K number: K101635
Comparison with predicate: C.

The modified TD-4268 Blood Glucose Monitoring System and TD-4268 Multi Blood Glucose Monitoring System have the following similarities to the predicate device:

の same operating principle,
动 same fundamental scientific technology,

ﻟﻘ incorporate the same basic circuit design,

ਿ incorporate the same materials,
网 same shelf life
E packaged using the same materials, and
િય manufactured by the same process.

The modifications encompass:

Modification in the physical appearance મ્પ્
湖 Minor software modifications of the glucose meter
Labeling change due to the above modifications ું
1. Test Principle:
- The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose dehydrogenase.
1. Performance Characteristics:

TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the TD-4268 Blood Glucose Monitoring System/TD-4268 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the TD-4268 Blood Glucose Monitoring System /TD-4268 Multi Blood Glucose Monitoring System are equivalent to the predicate device.

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8. Conclusion:

Based on the information provided in this submission, the TD-4268 Blood Glucose Monitoring System and TD-4268 Multi Blood Glucose Monitoring System are substantially equivalent to the predicate TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 an abstract symbol resembling a stylized caduceus or a representation of human figures.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

TAIDOC TECHNOLOGY CORPORATION c/o Meiru Li 3F,5F, No. 127, Wugong 2nd Rd. Wugu District New Taipei City China (Taiwan) 24888

MAY 2 2 2012

K120042 Re:

Trade Name: TD-4268 Blood Glucose Monitoring System, TD-4268 Multi Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR, NBW Dated: April 10, 2012 Received: April 23, 2012

Dear Meiru Li:

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 approvisions 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 reporting (reporting of mequirements 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 If you desire specific advice for your covice Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 prease note the regulation officies, "Anientarket surveillance, please contact CDRH 's CITY at 607.77). I of questions regarding postmarket Surveillance at (301) 0111cc or but villance and 22rding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

CFK Fall 805), prease go to map. www.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 Tou may of amall 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,

Couriney 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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Section 8.

Indications for Use

510(k) Number (if known):

Device Name: TD-4268 Blood Glucose Monitoring System, model TD-4268

Indications for Use:

The TD-4268 Blood Glucose Test Strips are for use with the TD-4268 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

AND/OR

Prescription Use 21 CFR 801 Subpart D)

Over-The-Counter Use __ X . (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 120042 510(k)

8-1

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Indications for Use

510(k) Number (if known):

Device Name: TD-4268 Multi Blood Glucose Monitoring System, model TD-4268

Indications for Use:

Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel.

The system is only used with single-use, auto-disabling lancing devices.

Over-The-Counter Use X AND/QR Prescription Use × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) == 120042

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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.