MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System

K143750 · Apex BioTechnology Corp. · CGA · May 7, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143750
• Device Name: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 7, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Story

System measures glucose in fresh capillary whole blood via test strips; provides quantitative results for diabetes management. MEG-2B used by lay people at home; MEG-2B Pro used by professionals in healthcare settings. Pro version requires single-use, auto-disabling lancing devices. Users apply blood sample to strip; meter processes sample and displays glucose concentration. Results assist healthcare providers and patients in monitoring diabetes control effectiveness. Modifications include addition of silver paint to meter case, change in LCD cover manufacturing site, and updated disinfectant recommendations.

Clinical Evidence

No clinical testing was conducted.

Technological Characteristics

Meter housing: ABS Chimei 709 with silver paint. LCD cover: Polycarbonate. Disinfection: Validated for use with Clorox Bleach Germicidal Wipes, Medline MicroKill Bleach Germicidal Wipes, and Medline Micro-Kill+ Disinfection/Cleaning Wipes with Alcohol.

Indications for Use

Indicated for individuals with diabetes to monitor glucose levels in fresh capillary whole blood (fingertip, forearm, palm). MEG-2B for home self-testing; MEG-2B Pro for professional multi-patient use. Not for neonatal use, diabetes diagnosis, or screening.

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.

Predicate Devices

• MEG-2B Blood Glucose Monitoring System/ MEG-2B Pro Blood Glucose Monitoring System (K120448)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Summary

To: THE FILE

RE: DOCUMENT NUMBER K143750

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):

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.) MEG-2B Blood Glucose Monitoring System/ MEG-2B Pro Blood Glucose Monitoring System (K120448)

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. Adding silver paint (ABS Chimei 709) to the meter housing
2. Changing the polycarbonate material for the LCD cover.
3. Adding three new agents for cleaning and disinfection: Clorox Bleach Germicidal Wipes, Medline MicroKill Bleach Germicidal Bleach Wipes, Medline Micro-Kill+ Disinfection, Deodorizing, Cleaning Wipes with Alcohol.

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.

Infection Control Studies: The MEG-2B Blood Glucose Monitoring System is intended for single patient use and the MEG-2B Pro Blood Glucose Monitoring System is intended for multiple-patient use. Disinfection efficacy testing was conducted by outside testing facilities and demonstrated complete inactivation of hepatitis B virus (HBV) or elimination of Hepatitis B surface antigen (HbsAg) with the following disinfectants: Dispatch Hospital Cleaner Disinfectant Towels with Bleach (EPA registration # 56392-8), Clorox Germicidal Wipes (EPA registration # 67619-12), Medline MicroKill Bleach Germicidal Bleach Wipes (EPA registration # 69687-1-37549), and Medline Micro-Kill+ Disinfection, Deodorizing, Cleaning Wipes with Alcohol (EPA registration # 59894-10-37549). Robustness studies were performed by the sponsor demonstrating that there were no changes in the performance or external materials of the meter after 10,950 cleanings and 10,950 disinfection cycles with the Dispatch Hospital Cleaner

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Disinfectant Towels with Bleach (EPA registration # 56392-8), and three additional disinfectants that were evaluated in the same manner in this submission: Clorox Germicidal Wipes (EPA registration # 67619-12), Medline MicroKill Bleach Germicidal Bleach Wipes (EPA registration # 69687-1-37549), and Medline Micro-Kill+ Disinfection, Deodorizing, Cleaning Wipes with Alcohol (EPA registration # 59894-10-37549). The robustness studies were designed to simulate 3 years of multiple patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.