(136 days)
The Easy2Check blood glucose and blood pressure monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from 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. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8".
This system offers wireless communication function which is able to transmit the test result to other devices, such as PC.
PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor. The system measures glucose in fresh capillary whole blood and measures non-invasively the systolic and diastolic blood pressure and pulse rate. It has wireless communication function.
The provided document is an FDA 510(k) clearance letter for the "PMP Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor". It does not contain a detailed study description with specific acceptance criteria and performance data. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This information is typically found in the 510(k) summary or the full 510(k) submission, which is not provided in these snippets. The document focuses on the FDA's regulatory decision, not on the detailed technical performance data of the device itself beyond its intended use.
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Image /page/0/Picture/1 description: The image contains a logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol, indicating the organization's name and affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Card Guard Scientific Survival Ltd c/o Alex Gonorovsky 2 Pekeris St Rehovot 76100 Israel
JAN 1 6 2009
Re K082521
Trade Name PMP Easy2Check Personal Wireless Blood Pressure and Blood Glucose
Monitor
Regulation Number 21 CFR 862 1345 Regulation Name Glucose Test System Regulatory Class Class II Product Codes NBW, CGA, DXN Dated December 2, 2008 Received December 2, 2008
Dear Mr Gonorovsky
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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon
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), 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) 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) 443-6597 or at its Internet address http //www fda gov/cdrh/dsma/dsmamain html
Sincerely yours,
r 2 . .
Courtney C Harper, Ph D Acting Director DIVISION of Chemistry and Toxicology Office of In Vitro Diagnostics Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): K082521
Device Name: PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor
Indication For Use:
The Easy2Check blood glucose and blood pressure monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from 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. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8".
This system offers wireless communication function which is able to transmit the test result to other devices, such as PC.
Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082521
§ 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.