(152 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No.
The device is for monitoring glucose levels, not for treating or preventing disease.
No
The "Intended Use / Indications for Use" states that the device "is not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly states the system consists of a meter, test strips, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (glucose levels).
- Device Description: The system consists of a meter, test strips, and control solutions, which are typical components of an IVD system used for chemical analysis of biological samples.
- Performance Studies: The performance studies focus on system accuracy and comparison to a predicate device, which are standard evaluations for IVD devices to demonstrate their reliability in providing accurate results.
- Predicate Device: The predicate device listed (U-RIGHT TD-4252 Blood Glucose Monitoring System) is also a blood glucose monitoring system, which is a well-established category of IVD devices.
The fact that it's used by people with diabetes at home for monitoring and not for initial diagnosis or screening doesn't change its classification as an IVD. It's still performing a diagnostic test on a biological sample in vitro.
N/A
Intended Use / Indications for Use
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.
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.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
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.
Product codes (comma separated list FDA assigned to the subject device)
LFR, NBW, JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood (from the finger, palm, forearm and upper arm)
Indicated Patient Age Range
The system is not intended for use on neonates.
Intended User / Care Setting
people with diabetes 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)
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.
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.
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
§ 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.
0
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
-
- 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
- Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
Prepared date: April 20th, 2012
-
- Device name:
Proprietary name: Genesis Health Technologies Blood Glucose Monitoring System, model TD-4123
- Device name:
-
Genesis Health Technologies control solutions
Regulatory information:
| A. Regulation section: | 21 CFR 862.1345 Glucose Test System
21 CFR 862.1660 Quality control material (assayed and
unassayed). |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Classification: | Class II, Class I |
| C. Product Code: | LFR, Glucose Dehydrogenase, Glucose
NBW, System, Test, Blood Glucose, Over the Counter
JJX, single (specified) analyte controls (assayed and
unassayed) |
| D. Panel: | Clinical Chemistry (75) |
1
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.
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.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
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.
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.
-
- 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. ■
2
- 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 Blood | |
| Glucose Monitoring System | ||
| (K101631) | Genesis Health | |
| Technologies Blood Glucose | ||
| Monitoring System | ||
| Model no | TD-4252 | TD-4123 |
| Similarities | ||
| Intended use | It is intended to be used for | |
| quantitative measurement of | ||
| glucose in fresh capillary whole | ||
| blood (from the finger, palm, | ||
| forearm and upper-arm) as an aid | ||
| to monitoring the effectiveness of | ||
| diabetes control. | Same as predicate | |
| Detection mechanism | ||
| Operating | ||
| principle | Electrochemical Biosensor | |
| technology | Same as predicate | |
| Detection | ||
| method | Amperometry: | |
| measuring a current produced by a | ||
| chemical reaction | Same as predicate | |
| Specifications | ||
| Temperature | ||
| compensation | Automatic compensation with | |
| built-in thermister | Same as predicate | |
| Sample | 0.7 µL | Same as predicate |
| volume (µL) | ||
| Reaction time | ||
| (sec) | 7 | Same as predicate |
| Measurement | ||
| range | 20-600 mg/dL | Same as predicate |
| Meter Storage/ | ||
| Transportation | ||
| condition | -4 to 140 (-20~60), | |
| 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).
7
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,
N
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
8
Indications for Use
510(k) Number: K121224
Device Name: Genesis Health Technologies Blood Glucose Monitoring System, model TD-4123
Indications for Use:
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.
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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