(88 days)
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No
The document describes a standard blood glucose monitoring system and contains no mention of AI, ML, or related concepts.
No
The device is a blood glucose monitoring system, used for quantitative measurement of glucose, which is a diagnostic or monitoring function, not a therapeutic one.
No
The device is stated to be "not intended for the diagnosis of or screening for diabetes mellitus". It is described as an "aid in monitoring the effectiveness of diabetes control program", which is a monitoring function, not a diagnostic one.
No
The description clearly indicates this is a "Blood Glucose Monitoring System" intended for measuring glucose in "fresh capillary whole blood". This implies the use of hardware components (e.g., a meter, test strips) to interact with the blood sample, which is not characteristic of a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It measures a substance in a biological sample: The intended use states it measures glucose in "fresh capillary whole blood". Blood is a biological sample.
- The measurement is performed outside of the body: The term "in vitro" means "in glass" or "outside of the body". Measuring glucose in a blood sample taken from the body is an in vitro process.
- It is used to provide information about a physiological state: The intended use states it is used "as an aid in monitoring the effectiveness of diabetes control program". This information helps manage a physiological condition (diabetes).
Therefore, based on the definition of an IVD, this blood glucose monitoring system fits the criteria.
N/A
Intended Use / Indications for Use
The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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, the upper-arm, the calf and the 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
Product codes
NBW, CGA
Device Description
Achtung TD-4207 no code, Clever Chek TD-4209 one-code, Clever Chek TD-4222 no code, Clever Chek TD-4225 no code, Clever Chek TD-4226 one-code Blood Glucose Monitoring Systems
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger, palm, forearm, upper-arm, calf, thigh
Indicated Patient Age Range
Not intended for use on neonates.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 2009
TaiDoc Technology Corporation c/o Ms. Sophie Lin 6F, No. 127, Wugong 2nd Rd., Wugu Township Taipei County, 241 Taiwan, R.O.C.
Re: K090185
Trade name: Achtung TD-4207 no code, Clever Chek TD-4209 one-code, Clever Chek TD-4222 no code, Clever Chek TD-4225 no code, Clever Chek TD-4226 one-code Blood Glucose Monitoring Systems Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 16, 2009 Received: April 16, 2009
Dear Ms. Lin:
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 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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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.
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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Indications for Use
510(k) Number:
Device Name: Achtung TD-4207 no code, Clever Chek TD-4209 one-code, Clever Chek TD-4222 no code, Clever Chek TD-4225 no code, Clever Chek TD-4226 one-code Blood Glucose Monitoring System
Indications for Use:
The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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, the upper-arm, the calf and the 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
Prescription Use | |
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(Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use | X |
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(21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off | |
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Office of In Vitro Diagnostic Device Evaluation and Safety | |
510(k) | K09185 |
A2 | Page 1 of 1 |
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