(30 days)
Not Found
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No.
This device is an In Vitro Diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative measurement of glucose" and for "In Vitro diagnostic use," which unequivocally classifies it as a diagnostic device.
No
The device description explicitly states that the system consists of a "meter" and "test strips," which are hardware components, not solely software.
Yes, based on the provided text, both the EM44 Self Monitoring Blood Glucose System and the EM44 Pro Self Monitoring Blood Glucose System are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both systems explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: Both systems are designed to quantitatively measure glucose in blood samples, which is a biological sample tested in vitro (outside the living organism) to provide diagnostic information.
Therefore, the text clearly identifies these devices as IVDs.
N/A
Intended Use / Indications for Use
The EM44 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EM44 Glucose Control Solution
For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EM44 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EM44 Glucose Control Solution
For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
Product codes
LFR, NBW, JJX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, or forearm (for EM44 Self Monitoring Blood Glucose System)
venous whole blood or fresh capillary whole blood from fingertip (for EM44 Pro Self Monitoring Blood Glucose System)
Indicated Patient Age Range
Not to be used on neonates.
Intended User / Care Setting
EM44 Self Monitoring Blood Glucose System: at home (over the counter [OTC]) by a single patient with diabetes.
EM44 Pro Self Monitoring Blood Glucose System: multiple-patient use in professional healthcare settings.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/0/Picture/4 description: The image shows the text 'SEP 0 ? 2011'. The text appears to be a date, with 'SEP' likely representing September. The day is unclear due to the question mark, but the year is clearly '2011'. The text is in a simple, bold font.
EPS Bio Technology Corp. c/o Y.C. Lei General Manager No.8 R&D Rd III. Hsinchu Science Park Hsinchu City, Hsinchu China (Taiwan) 300
Re: K112272
Trade Name: EM44 Pro and EM44 Self Monitoring Blood Glucose System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR, NBW, JJX Dated: August 2, 2011 Received: August 8, 2011
Dear Mr. Lei:
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 111 (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).
1
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 800 97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the regoring of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 for ( 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/or You/Industry/default.htm.
Sincerely yours,
jz
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K112272
Device Name: EM44 Self Monitoring Blood Glucose System
Indications For Use:
The EM44 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EM44 Glucose Control Solution
For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use (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 (OVD)
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112272
3
Indications for Use
510(k) Number (if known): K112272
Device Name: EM44 Pro Self Monitoring Blood Glucose System
Indications For Use:
The EM44 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EM44 Glucose Control Solution
For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
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 (OVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112272