FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM

• K Number: K111890
• Device Name: FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer: TaiDoc Technology Corporation
• Date Cleared: 2012-02-06 ( 220 days)
• Product Code: NBW LFR SYS
• Regulation Number: 862.1345

Intended Use

FORA Diamond Prima Blood Glucose Monitoring System is Intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. This system is intended for single-patient use and should not be shared. The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitys. and is not intended for use on neonates. This system is intended for single-patient use and should not be shared. The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Clucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

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. Use only FORA test strips and FORA control solutions (cleared under k093724) with the FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucosc Monitoring System.

Predicate Devices

K 100322

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.

Therapeutic

No
This device is a blood glucose monitoring system, which is used to measure blood glucose levels. It is an in vitro diagnostic device used for monitoring, not for direct therapy or treatment.

Diagnostic

Yes

This device is a blood glucose monitoring system, which is explicitly stated as being for "in vitro diagnostic use" in its intended use. While it's not for diagnosing or screening diabetes, it aids in monitoring the effectiveness of a diabetes control program, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of a meter, test strips, and control solutions, which are hardware components.

IVD (In Vitro Diagnostic)

Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Explicit Statement in Intended Use: Both the FORA Diamond Prima and FORA Diamond Mini systems explicitly state in their "Intended Use / Indications for Use" sections that they are "Intended for self testing outside the body (in vitro diagnostic use)".
• Measurement of Analytes in Biological Samples: The systems are designed for the "quantitative measurement of glucose in fresh capillary whole blood from the finger". Measuring analytes (glucose) in biological samples (blood) outside the body is a core characteristic of IVDs.
• Aid in Monitoring a Medical Condition: The systems are intended "as an aid in monitoring the effectiveness of diabetes control program". IVDs are often used to monitor medical conditions.

The text clearly aligns with the definition and purpose of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For FORA Diamond Prima Blood Glucose Monitoring System:

FORA Diamond Prima Blood Glucose Monitoring System is Intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended for single-patient use and should not be shared.

The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For FORA Diamond Mini Blood Glucose Monitoring System:

FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitys. and is not intended for use on neonates.

This system is intended for single-patient use and should not be shared.

The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Clucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Product codes (comma separated list FDA assigned to the subject device)

NBW, LFR

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. Use only FORA test strips and FORA control solutions (cleared under K093724) with the FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucosc Monitoring System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

finger

Indicated Patient Age Range

Not intended for use on neonates.

Intended User / Care Setting

self testing outside the body (in vitro diagnostic use), by people with diabetes mellitus at home, single-patient use (lay-users 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 FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System are equivalent to the predicate device.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K 100322

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

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

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FEB - 6 2012

Attachment A23. 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, SF, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
     Correspondent: Linda Ko Regulatory Affairs Specialist Tel: [phone] #1158 Fax: [phone] Email: [e-mail]

Prepared date: June 27, 2011

• 2. Device name:
     Proprietary name: FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System

Regulatory information:

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

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3. Intended Use:

For FORA Diamond Prima Blood Glucose Monitoring System:

FORA Diamond Prima Blood Glucose Monitoring System is Intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended for single-patient use and should not be shared.

The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For FORA Diamond Mini Blood Glucose Monitoring System:

FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitys. and is not intended for use on neonates.

This system is intended for single-patient use and should not be shared.

The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Clucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

And and the commend of the company of

4. 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. Use only FORA test strips and FORA control solutions (cleared under K093724) with the FORA Diamond Prima

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Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucosc Monitoring System.

• 5. Substantial Equivalence Information:
  • Predicate device name: TD-4277 blood glucose monitoring system A.
  • B. Predicate K number: K 100322
  • C. Comparison with predicate:

The modified FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System have the following similarities to the predicate device:

• 型 same operating principle,
• 网 same fundamental scientific technology,
• . incorporate the same basic circuit design,
• ir incorporate the same materials,
• E same shelf life
• 1:3 packaged using the same materials, and
• 분방 manufactured by the same process.

The modifications encompass:

• 国 Physical appearance change
• E Software modification of the glucose meter
• 포 Labeling change due to the above modifications
• 6. Test Principle:

.

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose dehydrogenase.

• 7. Performance Characteristics:
     FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System have the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA Diamond Prima Blood Glucose Monitoring System, FORA Diamond Mini Blood Glucose A23-3 of 3

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Monitoring System and the TD-4277 blood glucose monitoring system are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System are equivalent to the predicate device.

• 8. Conclusion:
     Based on the information provided in this submission, the FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System are substantially equivalent to the predicate TD-4279 blood glucose monitoring system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

FEB 0 6 2012

TAIDOC TECHNOLOGY CORPORATION C/O MEIRU LI 3F-5F NO. 127 WUGONG 2ª RD. WUGU DISTRICT NEW TAIPEI CITY CHINA (TAIWAN) 24888

K111890 Re:

K111890
Trade Name: FORA Diamond Prima Blood Glucose Monitoring System,
Trade Name: FORA Diamond Comment Comment System I rade Name. FORA Diamond Tricose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR Dated: December 29, 2011 Received: January 9, 2012

Dear Meiru Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Secuon 110(ts) picmailer is substantially equivalent (for the referenced above and have determined the device by squaredicate devices marketed in
indications for use stated in the enclosure) to he anstreant date of the Medical Device indications for use stated in the encosment of the enactment date of the Medical Device
interstate commerce prior to May 28, 1976, the enactment with the provisio interstate commerce prior to May 2, 1976, the circulation coace with the provisions of
Amendments, or to devices that have been receassified in accordance with the provisions Amendments, or to devices that have oeen recassions approval of a prematket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premains the Federal Food, Drug, and Cosmetic Act (Act (Act) that do not one of the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (PMA). Tou may, increases in the Act include controls provisions of the Act. The general of devices, good manufacturing practice,
requirements for annual registration, listing of devices, good manufacturing requirements for annual registration, noting of and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III
ns affective If your device is classified (see above) into elther class in (open major regulations affecting
(PMA), it may be subject to such additional controls. Existing (CFR). Parts 8 (PMA), it may be subject to such additions: Listingions (CFR), Partis 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Partis 800 to 800 your device can be found in Title 21, Code of Federal Kegalaton (12 - 7)
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 Please be advised that FDA's issuance of a substantials with other requirements
mean that FDA has made a determination that your device with other requirements. mean that FDA has made a determinations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any Federal statutes and regulations administers on the limited to: registration
You must comply with all the Act's requirements, including, but not limited dev You must comply with all the Act Stequirements, interactions)
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device and listing (21 CFR Part 807); labeling (21 CFR Parts overse events) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); regul reporting (reporting of medical device-related adverse ovensy (CS) regulation (21 CFR Part 820).

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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 [phone]. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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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Indications for Use

510(k) Number (if known): K111890

Device Name: FORA Diamond Prima Blood Glucose Monitoring System

Indications for Use:

FORA Diamond Prima Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended for single-patient use (lay-users at home) and should not be shared.

The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR (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 Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K111890

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Indications for Use

510(k) Number (if known): K111890

Device Name: FORA Diamond Mini Blood Glucose Monitoring System

Indications for Use:

FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended for single-patient use and should not be shared.

The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR (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 Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K111890

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