BGM014 Blood Glucose Monitoring System

K182992 · Apex BioTechnology Corp. · NBW · Nov 28, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182992
• Device Name: BGM014 Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 28, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The BGM014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

Device Story

BGM014 Blood Glucose Monitoring System consists of a meter and test strips for quantitative glucose measurement in capillary whole blood. Used by patients with diabetes at home for self-monitoring of glucose control. Device requires single-patient use. Operation involves applying blood sample to test strip; meter provides glucose concentration output. Modification from predicate includes updated user manual recommendations for an additional disinfectant. Device performance validated through disinfection (viral inactivation) and robustness testing to ensure safety and equivalence.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence supported by non-clinical bench testing, specifically disinfection efficacy and robustness testing.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Comprised of a blood glucose meter and test strips. System is identical to the predicate device. No changes to sensing principle or hardware; modification limited to user manual disinfection instructions.

Indications for Use

Indicated for single patient use for 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

• BGM014 Blood Glucose Monitoring System (k161299)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k182992

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device: k161299, BGM014 Blood Glucose Monitoring System. (For a preamendments device, a statement to this effect has been provided.)

2. Applicant’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 the addition of validated cleaning and disinfection instructions to the labeling for an alternative disinfectant wipe to clean and disinfect the meter.

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

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

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 applicant’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 applicant 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 Apex BGM014 Blood Glucose Monitoring System is intended for single patient use.

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Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial laboratory testing service and demonstrated complete inactivation of hepatitis B Virus (HBV) with Super Sani-Cloth Germicidal Disposal Wipe (EPA Reg. No: 9480-4). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 1,825 cleaning and disinfection cycles representing 5 years of single patient use with the Super Sani-Cloth Germicidal Disposable Wipes. Each robustness cycle tested consisted of one pre-clean wipe and one disinfecting wipe. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures and to ensure that no other changes were made.

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