TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System

K150052 · Nipro Diagnostics, Inc. · NBW · Mar 26, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150052
• Device Name: TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
• Applicant: Nipro Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

System measures glucose in capillary or venous whole blood via test strips; electrochemical biosensor technology. User applies blood sample to strip; meter performs quantitative analysis; displays glucose concentration. AIR version includes wireless connectivity for data transmission. Self-monitoring version intended for single-patient home use; PRO version intended for multi-patient professional healthcare settings using auto-disabling lancing devices. Output aids clinicians and patients in monitoring diabetes control effectiveness. Benefits include convenient, rapid glucose monitoring to support glycemic management.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological characteristics and performance specifications.

Technological Characteristics

Electrochemical glucose monitoring; Bluetooth Smart wireless connectivity; memory capacity 1000 test results; glucose averaging (7, 14, 30, 60, 90 days). No changes to surface materials. Validated for cleaning and disinfection.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip/forearm) for self-testing by people with diabetes; also indicated for venous whole blood in professional settings. Contraindicated for neonate use, diabetes diagnosis, or screening. Alternative site testing restricted to steady-state glucose conditions.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Summary

To: THE FILE

RE: DOCUMENT NUMBER K150052

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): TRUE METRIX AIR Self-Monitoring Blood Glucose System and TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) TRUE METRIX Self-Monitoring Blood Glucose System, TRUE METRIX PRO Professional Monitoring Blood Glucose System; K140100
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

1. The name has changed from TRUE METRIX Self-Monitoring Blood Glucose System to TRUE METRIX AIR Self-Monitoring Blood Glucose System; and TRUE METRIX PRO Professional Monitoring Blood Glucose System to TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System;
2. Addition of Bluetooth® Smart for wireless test data transfer;
3. Expanding the glucose meter memory from 500 to 1000 test results and;
4. Providing glucose average options of 60 and 90 days in addition to the existing 7, 14, and 30 days.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use and physical characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis (Failure Mode and Effect Analysis)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

There have been no changes to the surface materials of the TRUE METRIX AIR Self-Monitoring Blood Glucose System and TRUE METRIX AIR PRO Professional Monitoring Blood Glucose Systems in this submission. Validated disinfection efficacy and robustness studies were reviewed in K120989. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.