K Number

Device Name

ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276

Manufacturer

TaiDoc Technology Corporation

Date Cleared

2010-04-23

(122 days)

Product Code

NBW CGA

Regulation Number

862.1345

Intended Use

ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System, Model TD-4276, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The alternative site testing in the system can be used only during steady-state blood glucose conditions. The device is not to be used for the diagnosis or screening of diabetes or tested on neonates.

Device Description

The kit of ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System consist of four main products: the meter with blood glucose measurement function, test strips, control solution (cleared under k041107), and a lancing device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K072039

Reference Devices

K041107

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components in the intended use, device description, or performance studies.

Therapeutic

No
This device is for monitoring glucose levels, not for providing therapy or treatment.

Diagnostic

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device is not to be used for the diagnosis or screening of diabetes or tested on neonates." While it measures glucose, it is an "aid in monitoring the effectiveness of diabetes control program," not for initial diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states the kit consists of a meter with blood glucose measurement function, test strips, control solution, and a lancing device, indicating it is a hardware-based system with software components, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
Device Description: The description mentions "test strips" and "control solution", which are components typically used in in vitro diagnostic tests.
Function: The core function is "blood glucose measurement", which is an in vitro analysis of a blood sample.

The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, that have been taken from the human body to help detect infections, diagnose a medical condition, prevent disease, or monitor drug therapies. This device clearly fits this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is not to be used for the diagnosis or screening of diabetes or tested on neonates.

Product codes

NBW, CGA

Device Description

The kit of ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System consist of four main products: the meter with blood glucose measurement function, test strips, control solution (cleared under K041107), and a lancing device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

finger, palm, forearm, upper-arm, calf and thigh

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals and people with diabetes mellitus at home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing confirmed that the performance, safety and effectiveness of the ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System is equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072039

Reference Device(s)

K041107

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

APR 2 3 2010

Attachment B. 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: K093940

1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Debra Liang Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw

Date of submission: December 21, 2009

1. Device name:

Proprietary name: ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System

Regulatory information:

Regulation section: 21 CFR § 862.1345, Glucose Test System A.
Class II (Glucose Test System) B. Classification: NBW. System, Test, Blood Glucose, Over The Counter Product Code: C. CGA, Glucose Oxidase, Glucose 75, Clinical Chemistry - Glucose Test System Panel: D.

3. Intended Use:

The device is not to be used for the diagnosis or screening of diabetes or tested on neonates.

1. Device Description:
  The kit of ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System consist of four main products: the meter with blood glucose measurement function, test strips, control solution (cleared under K041107), and a lancing device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
1. Substantial Equivalence Information:
  A. Predicate device name: ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4223F Predicate K number: K072039

Comparison with predicate: B.

The modified ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System has the following similarities to the predicate device:

same operating principle, ■
same fundamental scientific technology,
I incorporate the same basic circuit design,
l incorporate the same materials,
same shelf life
1 packaged using the same materials, and

Manufactured by the same process.
The modifications encompass:
Software modification ■
Removal of ketone warning message
트 Physical appearance change
Engineering change
마 Memory capacity change
Removal of data transmission function L
Labeling change due to the above modifications
1. Test Principle:

For blood glucose, the detection and measurement is by an electrochemical biosensor technology using glucose oxidase.

1. Performance Characteristics:
  The ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System is substantially equivalent to the predicate ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4223F.

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

TaiDoc Technology Corporation c/o Debra Liang Regulatory Affairs Specialist 6F, No.127, Wugong 2nd Rd., Wugu Township Taipei County, China (Taiwan) 248

APR 2 3 2010

K093940 Re: Trade/Device Name: ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System, Model TD-4276 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 12, 2010 Received: April 14, 2010

Dear Ms. Liang

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Section 8 Indications for Use

Indications for Use

510(k) Number: KD93940

Device Name: ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System, Model TD-4276

Indications for Use:

The device is not to be used for the diagnosis or screening of diabetes or tested on neonates.

Over the Counter Use __X Prescription Use _____________________________________________________________________________________________________________________________________________________________ × And/Or (21 CFR Part 801 Subpart D) (21 CFR Part 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 Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_15093940

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