ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM

K070088 · Apex BioTechnology Corp. · NBW · Feb 16, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070088
• Device Name: ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The intended use of the modified device as described in its labeling has not changed.

Device Story

Blood glucose monitoring system; measures glucose in capillary whole blood samples. Device utilizes test strips inserted into a meter port; electrochemical reaction produces signal proportional to glucose concentration. Modifications include: strip engineering to reduce required blood volume via mesh removal; physical design changes to prevent strip interchangeability with Assure 3 meter; increased memory capacity; control mode flagging; removal of mmol/L unit option (mg/dL only); expanded operating temperature range; power supply change to two AA batteries; cosmetic casing changes. Used by patients for self-monitoring or clinicians in point-of-care settings. Output displayed on meter screen; informs insulin dosing or dietary adjustments; assists in glycemic control.

Clinical Evidence

Clinical testing performed with persons with diabetes. Bench testing included precision, interferences, linearity, altitude effects, hematocrit effects (30-55%), minimum sample volume (1.5 µL), stability, control solution functionality, and temperature/humidity effects. No specific clinical performance metrics (e.g., sensitivity/specificity) provided in summary.

Technological Characteristics

Electrochemical glucose sensing; test strip with modified mesh for reduced blood volume. Power: two AA batteries. Memory: increased capacity. Units: mg/dL only. Operating temperature: expanded range. Casing: modified for power supply and differentiation. Software: embedded firmware for glucose calculation and memory management.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood. Patient population includes individuals with diabetes requiring blood glucose monitoring.

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

• Glucosure BGM

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K070088

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.) k011233
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. Engineering changes to the strip allowing for smaller blood volumes. Removal of a mesh component in the strip allows for less dispersal of the components which reduces the need for a larger volume.
B. and changes to the strip and insert port to disable interchangeability of the test strips with the Assure 3 meter.
C. Increased memory capacity.
D. Modification of how the control mode is entered and the ability to flag control results so they can be stored in memory.
E. Users can now only use mg/dL, as the mmol/L option has been removed.
F. Allowance of a wider operating temperature.
G. Changed the power supply from one CR-2032 battery to two AA batteries.
H. Cosmetic changes to the casing to differentiate it from the Assure 3 and to accommodate the new power supply.

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.