(88 days)
The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
Not Found
This is an FDA 510(k) clearance letter for the EasyMax N Self-Monitoring Blood Glucose Meter. The document describes the device's indications for use and states that the FDA found it substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain details about specific acceptance criteria for performance, a study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These are typically found in the summary of safety and effectiveness, or detailed study reports which are not included in this letter.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document primarily serves as a regulatory clearance acknowledgment, not a detailed technical performance report.
What is provided in the document:
- Device Name: EasyMax N Self-Monitoring Blood Glucose Meter
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips or forearm, for in vitro diagnostic use at home (OTC) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
- Regulatory Information: Class II device, Product Code NBW, CGA, Regulation Number 21 CFR 862.1345 (Glucose test system).
- Predicate Device: The device was found substantially equivalent to legally marketed predicate devices.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EPS B10 Technology Corp c/o Mr Y C Lei General Manager 2F, No 49-2, Lane 2, Guang Fu Rd , Sec 2 Hsinchu City, Tarwan, ROC
JAN 1 6 2009
Re K083099
Trade/Device Name EasyMax N Self-Monitoring Blood Glucose Meter Regulation Number 21 CFR 862 1345 Regulation Name Glucose test system Regulatory Class Class II Product Code NBW, CGA Dated December 19, 2008 Received December 22, 2008
Dear Mr Leı
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 regustration. Insting 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), 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 Iogally marketed predicate device results in a classification for your device and thus, begine to repress 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, "Mısbranding 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 tolloffre and ber (800) 638-2041 or (301) 443-6597 or at 1ts Internet address http //www fda gov/cdrh/dsma/dsmamain html
Sincerely yours,
Cory C. Hill
Courtney C Harper, Ph D Acting Director DIVISIOn of Chemistry and Tox1cology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known) K083099
Device Name EasyMax N Self Monitoring Blood Glucose Test System
Indication For Use
The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
Prescription Use V (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use V (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)
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Division Sign-Off Office of In Vitro Diagnostic Device
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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.