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.

AI/ML Overview

This 510(k) summary describes the "FORA Diamond Prima Blood Glucose Monitoring System" and "FORA Diamond Mini Blood Glucose Monitoring System." The information regarding acceptance criteria and study details is limited as it relies heavily on substantial equivalence to a predicate device (TD-4277, K100322) rather than presenting new detailed performance studies.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., ISO 15197 standards). Instead, it relies on the assertion of substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (TD-4277, K100322) in performance characteristics	"A comparison of system accuracy performance demonstrated that the FORA Diamond Prima Blood Glucose Monitoring System, FORA Diamond Mini Blood Glucose Monitoring System and the TD-4277 blood glucose monitoring system are substantially equivalent."
Performance, safety, and effectiveness equivalent to the predicate device	"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."

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "A comparison of system accuracy performance" without providing details.

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

This information is not provided. Given that it's a blood glucose monitoring system, the "ground truth" would typically refer to a laboratory reference method (e.g., YSI analyzer) rather than expert human interpretation.

4. Adjudication Method for the Test Set:

Not applicable or not specified.

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

Not applicable. This type of study is relevant for imaging or diagnostic devices where human readers interpret results, comparing aided vs. unaided performance. For a blood glucose meter, the output is a numerical value.

6. Standalone (Algorithm Only) Performance:

The entire system (meter, test strips, control solutions) is presented as a standalone device for measuring glucose. However, the document does not present separate "algorithm only" performance data distinct from the overall system performance. The "algorithm" is embedded within the meter's software. The study essentially demonstrates the standalone performance of the device (meter + strip) as it is intended to be used.

7. Type of Ground Truth Used:

The document implicitly refers to a "comparison of system accuracy performance" against the predicate device. For blood glucose meters, the ground truth is typically established using a highly accurate laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated, this is the standard for such devices.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is common for predicate-based submissions where the original predicate device's data or established engineering principles are relied upon. Any "software modification" mentioned would have its own internal testing, but details are not provided.

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

This information is not provided. If a training set was used for software development, the ground truth would likely have been established through a reference method (e.g., YSI analyzer). However, the document focuses on the end-product's equivalence to a predicate.

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: +886-2-6625-8188 #1158 Fax: +886-2-6625-0288 Email: kolinda@taidoc.com.tw

Prepared date: June 27, 2011

1. 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:

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:

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:

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

1. 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
1. Test Principle:

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

1. 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.

1. 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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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/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 (800) 638-2041 or (301) 796-5680 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.

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

Page 1 of 2

A22-1 of 2

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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:

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

Page 2 of

A22-2 of 2

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.