GAL-1A BLOOD GLUCOSE MONITORING SYSTEM

K113208 · Apex BioTechnology Corp. · CGA · Jan 26, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113208
• Device Name: GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

GAL-1A Blood Glucose Monitoring System: The GAL-1A 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 indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. GAL-1A Blood Glucose Test Strips: The GAL-1A Blood Glucose Test Strips are to be used with the GAL-1A Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Story

GAL-1A Blood Glucose Monitoring System; modified version of GAL-1C (k102816). Modifications include change in meter shape/size (horizontal to vertical layout; 56Lx63Wx13H mm to 76Lx45Wx13H mm); rearrangement of display icons. Device intended for single-patient blood glucose monitoring. System validated for disinfection efficacy against hepatitis B virus (HBV) using Dispatch Hospital Cleaner Disinfectant Towels with Bleach. Robustness testing simulated 5 years of use (1825 cleaning/disinfection cycles) with no performance degradation.

Clinical Evidence

No clinical diagnostic data provided. A user study was conducted to evaluate system ease-of-use and user manual comprehension. Results demonstrated substantial equivalence to the predicate system.

Technological Characteristics

Glucose test system using electrochemical sensing. Features vertical LCD display and modified meter housing. Software verification and validation performed. Connectivity/materials not specified beyond standard meter components.

Indications for Use

Indicated for lay use by people with diabetes to monitor blood glucose levels in Diabetes Mellitus. Samples: fresh capillary whole blood from fingertips, forearm, or palm. Not for diagnosis/screening of diabetes or 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

• GAL-1C Blood Glucose Monitoring System (k102816)

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: k113208

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) for the GAL-1A Blood Glucose Monitoring System:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: GAL-1C Blood Glucose Monitoring System; k102816.
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:
- Modifications to the design of the meter shape and size to change from a horizontal LCD layout to a vertical layout.
- Meter display icons were rearranged to re-orient the display
- Meter size changed from 56Lx63Wx13H (mm) to 76Lx45Wx13H (mm).
- Change in system name from "GAL-1C Blood Glucose Monitoring System" to "GAL-1A Blood Glucose Monitoring System".

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.
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.

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The device system is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Dispatch Hospital Cleaner Disinfectant Towels with Bleach (EPA Registration #56392-8). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter and lancing device after 1825 cleanings and 1825 disinfection steps with the Dispatch wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.