The Genesis Health Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, and the upper-arm. It 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 to be used by a single person and should not be shared.

The Genesis Health Technologies test strips are for use with the Genesis Health Technologies meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.

The alternative site testing in the Genesis Health Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The Genesis Health Technologies control solutions are for use with the Genesis Health Blood Glucose meter and test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

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

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

The provided text describes a 510(k) submission for a blood glucose monitoring system. Crucially, it does not provide explicit acceptance criteria with specific numerical thresholds for accuracy, nor does it detail a standalone study proving the device meets new acceptance criteria.

Instead, the submission for the Genesis Health Technologies Blood Glucose Monitoring System (model TD-4123) is based on demonstrating substantial equivalence to a predicate device, the U-RIGHT TD-4252 Blood Glucose Monitoring System (K101631). This means the focus of the "study" described is to show that the new device performs similarly or identically to an already approved device, rather than meeting a new, independently established set of performance targets.

Therefore, the table and other information below are derived from the available information, noting the absence of certain details that would be present in a submission proving performance against novel acceptance criteria.

1. Table of Acceptance Criteria (Implied by Substantial Equivalence to Predicate) and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate device that the new device aims to match. The "reported device performance" is the claim that the new device performs equivalently based on comparative testing.

Acceptance Criteria (Implied from Predicate Device)	Reported Device Performance (Genesis Health Technologies Blood Glucose Monitoring System)
Intended use: Quantitative measurement of glucose in fresh capillary whole blood (finger, palm, forearm, upper arm) for diabetes control, not for diagnosis/screening or neonates.	Same as predicate (stated: "Same as predicate")
Detection mechanism: Electrochemical Biosensor technology	Same as predicate (stated: "Same as predicate")
Detection method: Amperometry (measuring current from chemical reaction)	Same as predicate (stated: "Same as predicate")
Sample volume: 0.7 µL	Same as predicate (stated: "Same as predicate")
Reaction time: 7 seconds	Same as predicate (stated: "Same as predicate")
Measurement range: 20-600 mg/dL	Same as predicate (stated: "Same as predicate")
Temperature compensation: Automatic with built-in thermister	Same as predicate (stated: "Same as predicate")
Strip Ejection: Yes	Same as predicate (stated: "Same as predicate")
Power saving: Auto turn-off after 3 minutes without action	Same as predicate (stated: "Same as predicate")
Calibration: No coding required	Same as predicate (stated: "Same as predicate")
Alarm Function: 4 settings	Same as predicate (stated: "Same as predicate")
Memory feature: 450 measurements with day and time	Same as predicate (stated: "Same as predicate")
Test strip enzyme: Glucose dehydrogenase	Same as predicate (stated: "Same as predicate")
Test strip detection method: Amperometry	Same as predicate (stated: "Same as predicate")
Test strip blood volume: 0.7 µL	Same as predicate (stated: "Same as predicate")
Test strip reaction time: 7 Sec	Same as predicate (stated: "Same as predicate")
Meter Storage/Transportation condition: -4 to 140 (-20~60), <95% R.H.	Same as predicate (stated: "Same as predicate")
Strip Storage/Transportation condition: 35.6°F and 89.6°F (2°C and 32°C), below 85% R.H.	Same as predicate (stated: "Same as predicate")
System accuracy performance: Equivalent to predicate device.	Demonstrated that the Genesis Health Technologies Blood Glucose Monitoring System and the predicate are substantially equivalent in system accuracy.

Note: The "Differences" listed (e.g., power source, battery recharging, measurement unit, test strip indication light, backlight, special message, measurement mode, QC storage, day average, size, weight, data transmission capable) are modifications. For these, the claim is that despite these differences, the core performance characteristics (especially accuracy) remain equivalent.

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

Sample Size: Not explicitly stated in the provided text for the comparative accuracy study.
Data Provenance: Not explicitly stated. Given the manufacturer is based in Taiwan, it's plausible the study was conducted there, but this is not confirmed. The text does not specify if the study was retrospective or prospective.

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

Not applicable in the context of this submission. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer), not by expert consensus readings of images or clinical assessments. The submission does not detail the reference method or the personnel performing the reference tests.

4. Adjudication Method for the Test Set

Not applicable/not provided. As mentioned above, ground truth for blood glucose is typically a laboratory reference measurement, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. MRMC studies are typically for image interpretation tasks where different human readers interpret cases. Blood glucose monitoring systems are automated devices, and their performance is evaluated against a laboratory reference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The "system accuracy performance" comparison would inherently be a standalone assessment of the device (meter and test strip) against a reference standard. The text states:

"A comparison of system accuracy performance demonstrated that the Genesis Health Technologies Blood Glucose Monitoring System and the U-RIGHT TD-4252 Blood Glucose Monitoring System are substantially equivalent."
"Software verification and validation testing confirmed that the performance, safety and effectiveness of the Genesis Health Technologies Blood Glucose Monitoring System are equivalent to the predicate device."

These statements indicate testing of the device's inherent performance.

7. The Type of Ground Truth Used

The text strongly implies that the ground truth for "system accuracy performance" was an objective laboratory reference method. For blood glucose meters, this typically involves comparing the meter's readings to a validated laboratory analyzer (e.g., a YSI STAT PLUS Glucose & L-Lactate Analyzer) which provides highly accurate glucose measurements from the same blood samples. The exact reference method is not specified, but it would not be expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. The Genesis Health Technologies Blood Glucose Monitoring System is a hardware-based electrochemical biosensor system with integrated software. It is not described as an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "software modifications" mentioned would have undergone software verification and validation, but not "training" on a data set.

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

Not applicable, as there's no mention of a "training set" for an AI/ML algorithm.

Summary

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510(K) SUMMARY

SEP
19
2012

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: K121224

1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, 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: April 20th, 2012

1. Device name:
  Proprietary name: Genesis Health Technologies Blood Glucose Monitoring System, model TD-4123
Genesis Health Technologies control solutions
Regulatory information:

A. Regulation section:	21 CFR 862.1345 Glucose Test System21 CFR 862.1660 Quality control material (assayed andunassayed).
B. Classification:	Class II, Class I
C. Product Code:	LFR, Glucose Dehydrogenase, GlucoseNBW, System, Test, Blood Glucose, Over the CounterJJX, single (specified) analyte controls (assayed andunassayed)
D. Panel:	Clinical Chemistry (75)

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3. Intended Use:

For single use device

The Genesis Health Technologies Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood (from the finger, palm, forearm and upper arm). It is intended for use by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates.

This system is intended to be used by a single person and should not be shared.

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

4. Device Description:

1. Substantial Equivalence Information:
- Predicate device name: U-RIGHT TD-4252 Blood Glucose Monitoring System, A. model TD-4252
- Predicate K number: K101631 B.
- ে Comparison with predicate:

The modified Genesis Health Technologies Blood Glucose Monitoring System has the following similarities to the predicate device:

Same operating principle.
Same fundamental scientific technology. 트
. Incorporate the same basic circuit design.
Incorporate the same materials. ■

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Same shelf life.
E Packaged using the same materials.
Manufactured by the same process. ■

The modifications encompass:

Modifications in the physical appearance
에 Software modifications of the glucose meter
Rechargeable Li-polymer battery instead of CR2032 battery
배송 Labeling change due to the above modifications

	E. Similarities and Differences between predicate and proposed device

Item	Predicate device	Proposed device
Brand name	U-RIGHT TD-4252 BloodGlucose Monitoring System(K101631)	Genesis HealthTechnologies Blood GlucoseMonitoring System
Model no	TD-4252	TD-4123
Similarities
Intended use	It is intended to be used forquantitative measurement ofglucose in fresh capillary wholeblood (from the finger, palm,forearm and upper-arm) as an aidto monitoring the effectiveness ofdiabetes control.	Same as predicate
Detection mechanism
Operatingprinciple	Electrochemical Biosensortechnology	Same as predicate
Detectionmethod	Amperometry:measuring a current produced by achemical reaction	Same as predicate
Specifications
Temperaturecompensation	Automatic compensation withbuilt-in thermister	Same as predicate
Sample	0.7 µL	Same as predicate

volume (µL)
Reaction time(sec)	7	Same as predicate
Measurementrange	20-600 mg/dL	Same as predicate
Meter Storage/Transportationcondition	-4 to 140 (-20~60),<95% R.H.	Same as predicate
Strip Ejection	Yes	Same as predicate
Functions
Power saving	Auto turn-off after 3 minuteswithout action	Same as predicate
Calibration	No coding required	Same as predicate
AlarmFunction	4 settings	Same as predicate
Memoryfeature	450 measurements with day andtime	Same as predicate
Test Strip
Enzyme	Glucose dehydrogenase	Same as predicate
Detectionmethod	Amperometry: measuring acurrent produced by a chemicalreaction	Same as predicate
Blood Volume	0.7 µL	Same as predicate
Reaction time	7 Sec	Same as predicate
Strip Storage/Transportationcondition	35.6°F and 89.6°F (2 ° C and 32°C), below 85% R.H.	Same as predicate
Differences
Power source :	One CR2032 battery	1x 3.7V Li-polymer battery
Batteryrechargingfunction	No	With the battery rechargingfunction through USB
Measurementunit	mg/dL or mmol/L	mg/dL
Test strip indication light	No	Yes
Backlight	No	Yes
Special message	There is a “Ketone?” indicator that shows on the display	No ketone warning symbol provided
Measurement mode	General and QC (quality control)	General, AC, PC and QC (quality control)
QC test stored in memory	No QC results are stored in memory	Yes (User can review QC test in Data record review mode)
Day average	7,14,21,28,60,90 Days	Not provided
Size	89.6(L) x53.8 (W) x16.1 (H)mm	98.5(L) x 58(W) x 15.5(H)mm
Weight	40.6g (Without Battery)	51.4 g (Without Battery)
Data Transmission Capable	No	CDMA module(disabled)

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1. Test Principle:
  The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose dehydrogenase.
1. Performance Characteristics:
  Genesis Health Technologies Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the Genesis Health Technologies Blood Glucose Monitoring System and the U-RIGHT TD-4252 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the Genesis Health Technologies Blood Glucose Monitoring System are equivalent to the predicate device.

The cleaning and disinfection protocol employed by the two systems is validated for the effectiveness of disinfecting HBV, and are robust to cleaning and disinfection procedures after multiple cleaning and disinfection cycles.

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8. Conclusion:

Based on the information provided in this submission, the Genesis Health Technologies Blood Glucose Monitoring System is substantially equivalent to the predicate U-RIGHT TD-4252 Blood Glucose Monitoring System.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is an abstract image of an eagle.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

TaiDoc Technology Corporation c/o Linda Ko 3F, 5F, No. 127, Wugong 2nd Rd. Wugu District New Taipei City CHINA (TAIWAN) 24888

1 9 2012

Re: K121224

Trade Name: Genesis Health Technologies Blood Glucose Monitoring System, Model TD-4123 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System

Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: August 14, 2012 Received: August 23, 2012

Dear Ms Ko:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements 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 11 you desire specific at vice 101 your stic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 picase note the rogulation enimes, "inding postmarket surveillance, please contact CDRH30 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Onlec of But villanoo and 22rding 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 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/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: K121224

Device Name: Genesis Health Technologies Blood Glucose Monitoring System, model TD-4123

Indications for Use:

This system is intended to be used by a single person and should not be shared.

The alternative site testing in the Genesis Health Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

And/Or Over the Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Copeurpence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) 17/2012 ust users Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k12)27 4

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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.