(387 days)
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No
The provided text describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No
This device is intended for the measurement of glucose to aid in monitoring the effectiveness of diabetes control, not for directly treating or curing diabetes.
No
The text explicitly states: "The TRUE METRIX™ Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use." and "The system is not to be used on neonates or for the diagnosis or screening of diabetes mellitus." This indicates it is not a diagnostic device, but rather a monitoring device.
No
The device description is not provided, but the intended use clearly describes a "Blood Glucose System" which includes a "Meter" and "Test Strips." These are hardware components necessary for the device's function, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home..."
- "Testing is performed outside the body (in vitro diagnostic use) as an aid for monitoring the effectiveness of diabetes control."
This language clearly indicates that the device is intended for testing biological samples (blood) outside of the body to provide information about a person's health status (glucose levels related to diabetes), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TRUE METRIX™ Self Monitoring Blood Glucose System:
The TRUE METRIX™ 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. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not be shared.
The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for selftesting 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™ Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).
The TRUE METRIX Test Strips are for use with the TRUE METRIX™ Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE METRIX Test Strips to check that the meter and the test strip are working together properly and that the test is performing correctly.
TRUE METRIX PRO™ Professional Monitoring Blood Glucose System:
The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended to be used 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 PRO Professional Monitoring 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 for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions.
The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX Control Solution is for use with the TRUE METRIX PRO Professional Monitoring Meter and TRUE METRIX PRO Test Strips to check that the meter and test strip are working together properly and that the test is performing correctly.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
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 (for capillary whole blood samples); Not specified for venous whole blood.
Indicated Patient Age Range
Not to be used on neonates.
Intended User / Care Setting
TRUE METRIX™ Self Monitoring Blood Glucose System: "to be used by a single person and not be shared," "by people with diabetes at home."
TRUE METRIX PRO™ Professional Monitoring Blood Glucose System: "for 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
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2013
Nipro Diagnostics, Inc. C/O Karen De Vincent 2400 NW 55th Court FORT LAUDERDALE FL 33309
Re: K120989
Trade/Device Name: TRUE METRIX™ Self Monitoring Blood Glucose System TRUE METRIX PRO™ Professional Monitoring Blood Glucose
System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: April 16, 2013 Received: April 18, 2013
Dear Ms. De Vincent:
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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2-Ms. DeVincent
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -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 Form
510(k) Number (if known): K120989
Device Name: TRUE METRIX™ Self Monitoring Blood Glucose System
Indications for Use:
The TRUE METRIX™ 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. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not be shared.
The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for selftesting 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™ Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).
The TRUE METRIX Test Strips are for use with the TRUE METRIX™ Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE METRIX Test Strips to check that the meter and the test strip are working together properly and that the test is performing correctly.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
V_____________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR) Kathering Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K120989
3
Indications for Use Form
510(k) Number (if known): K120989
Device Name: TRUE METRIX PRO™ Professional Monitoring Blood Glucose System
Indications for Use:
The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended to be used 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 PRO Professional Monitoring 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 for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions.
The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX Control Solution is for use with the TRUE METRIX PRO Professional Monitoring Meter and TRUE METRIX PRO Test Strips to check that the meter and test strip are working together properly and that the test is performing correctly.
Prescription Use V . (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Devices and Radiological Health
510(k) K120989