(73 days)
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No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No
The device is described as an aid to monitor the effectiveness of diabetes control by measuring glucose levels, not for treating or curing the condition.
Yes
The intended use statements for both the TRUE METRIX AIR Self-Monitoring Blood Glucose System and the TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System explicitly state they are for "in vitro diagnostic use." This unequivocally identifies them as diagnostic devices, as they are used to measure glucose as an "aid to monitor the effectiveness of diabetes control."
No
The device is described as a "Self-Monitoring Blood Glucose System" and a "Professional Monitoring Blood Glucose System," which explicitly includes a "Meter" and "Test Strips." These are hardware components necessary for the device's function of measuring glucose in blood samples.
Yes, both the TRUE METRIX AIR Self-Monitoring Blood Glucose System and the TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System are explicitly stated to be IVD (In Vitro Diagnostic) devices.
The text clearly states:
- "The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use)..."
- "Testing is performed outside the body (in vitro diagnostic use)..." (referring to the PRO system)
N/A
Intended Use / Indications for Use
The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended to be used by a single person and not shared.
The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX AIR Self-Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. Alternative site testing can only be performed during steady-state blood times (when glucose is not changing rapidly).
The TRUE METRIX Self-Monitoring Test Strips are for use with the TRUE METRIX AIR Self-Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX AIR PRO Professional Blood Glucose System is intended for multiple patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX AIR PRO Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm or venous whole blood.
Product codes
NBW
Device Description
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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
fingertip or forearm, venous
Indicated Patient Age Range
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Intended User / Care Setting
TRUE METRIX AIR Self-Monitoring Blood Glucose System: single person, at home
TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System: multiple patient use in professional healthcare settings
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)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NIPRO DIAGNOSTICS, INC SIMEON SIMONE INTL REGULATORY AFFAIRS SPECIALIST II 2400 NW 55TH COURT FORT LAUDERDALE FL 33309
March 26, 2015
Re: K150052
Trade/Device Name: TRUE METRIX AIR Self-monitoring Blood Glucose System TRUE METRIX AIR PRO Professional Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II
Product Code: NBW Dated: February 24, 2015 Received: February 26, 2015
Dear Simeon Simone:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Stayce Beck -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150052
Device Name
TRUE METRIX AIR Self-Monitoring Blood Glucose System
Indications for Use (Describe)
The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended to be used by a single person and not shared.
The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX AIR Self-Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. Alternative site testing can only be performed during steady-state blood times (when glucose is not changing rapidly).
The TRUE METRIX Self-Monitoring Test Strips are for use with the TRUE METRIX AIR Self-Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K150052
Device Name
TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System
Indications for Use (Describe)
The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX AIR PRO Professional Blood Glucose System is intended for multiple patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX AIR PRO Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm or venous whole blood.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."