MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

K120448 · Apex BioTechnology Corp. · CGA · Apr 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120448
• Device Name: MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device system is intended for single-patient (MEG-2B) or multiple-patient use (MEG-2B Pro).

Device Story

Blood glucose monitoring system; includes meter, test strips, and control solutions. Input: fresh capillary whole blood sample applied to test strip. Principle: electrochemical measurement of glucose. Output: quantitative glucose concentration displayed on meter. MEG-2B version for home use by patients; MEG-2B Pro version for clinical use by healthcare professionals. Pro version requires single-use, auto-disabling lancing devices. Healthcare providers use output to monitor diabetes management. Benefits: provides rapid glucose data for glycemic control.

Clinical Evidence

No clinical data. Bench testing only, including EMC, electrical safety, drop testing, test strip holder qualification, software verification/validation, control solution qualification, and linearity testing.

Technological Characteristics

Electrochemical glucose monitoring system. Components: meter, test strips, control solutions. Modified strip dimensions: 38x6x0.4 mm. Sample channel: 1.4W x 3.4L x 0.135H mm. Sample volume: ≥0.8ul. Coding: 7-code system. Altitude range: up to 10,335 feet. Disinfection: validated for use with EPA-registered bleach-based wipes.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm) for patients with Diabetes Mellitus. MEG-2B for single-patient lay use; MEG-2B Pro for multi-patient clinical use by healthcare professionals. Contraindicated for diabetes diagnosis, screening, and neonatal use.

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-2 and MEG-2 Multi Blood Glucose Monitoring System (k101204)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k120448

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.) k101204 MEG-2 and MEG-2 Multi Blood Glucose Monitoring System.

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:

A. The new MEG-2B and MEG-2B Pro systems use a modified test strip and test strip holder relative to the predicate MEG-2 and MEG-2 Multi systems.

The changes are:

- Width of the strip holder (8mm to 6mm)
- Size of test strip (from 18x8x0.4 mm to 38x6x0.4 mm)
- Dimension of sample channel: from 1.4Wx3.4Lx0.15H (mm) to 1.4W x 3.4Lx 0.135H (mm)
- Sample size: from >1ul to ≥0.8ul

B. The new MEG-2B and MEG-2B Pro meters use the same basic measurement algorithm as the predicate meters, but the software has been modified to function with the modified test strip holder and test strip which use a 7-code system instead of the predicate 4-code system.

C. The new MEG-2B and MEG-2B Pro systems use modified control solutions. The new MEG-2B control solutions have the same chemical components (including a red dye) as the predicate MEG-2 control solutions, but have slightly different glucose levels. Otherwise the formulation is identical.

D. Altitude limitation from 6560 feet to 10335 feet. The MEG-2B strip is identical to the GAL-1C strip previously cleared in the GAL-1C BGMS in k102816. The altitude study in k102816 supported the altitude limitation of 10335 feet.

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E. The name of the device has changed from “MEG-2 and MEG-2 Multi Blood Glucose Monitoring System” to “MEG-2B and MEG-2B Pro Blood Glucose Monitoring System”

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.

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
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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.

The device system is intended for single-patient (MEG-2B) or multiple-patient use (MEG-2B Pro). Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by outside commercial testing demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Dispatch Hospital Cleaner Disinfectant Towels with Bleach disposable wipes (EPA Reg. No: 56392-8). The sponsor also demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 1,825 cleaning and disinfection cycles to simulate 5 years of use by lay-users and after 10,950 cleaning and disinfection cycles to simulate 3 years of multiple-patient use.

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