RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN

K123008 · Bionime Corporation · NBW · Jan 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123008
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 25, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure alucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Story

Blood glucose monitoring systems (meters and test strips) for quantitative glucose measurement in capillary whole blood; intended for single-patient home use. Modifications include updated device naming, adjusted test strip reagent percentages, revised interference concentration thresholds (uric acid, ascorbic acid, dopamine HCl, L-Dopa), reduced sample volume (1.0 μl to 0.75 μl), and changes to meter dimensions, weight, and power supply. Systems utilize electrochemical biosensor technology to measure glucose levels. Users apply blood sample to test strip; meter processes signal to display glucose concentration. Results assist patients in monitoring diabetes control. Cleaning/disinfection validated for 550 cycles using Discide Ultra towelettes to ensure material integrity over 5-year simulated use.

Clinical Evidence

Bench testing only. Validation included performance testing of modified test strip reagents and interference thresholds. Material integrity testing confirmed no degradation after 550 cleaning/disinfection cycles using Discide Ultra towelettes, simulating 5 years of use. Hepatitis B surface antigen testing validated the efficacy of the disinfection protocol on meter and lancing device materials.

Technological Characteristics

Electrochemical glucose biosensor system. Modifications: reduced sample volume (0.75 μl), adjusted reagent concentrations, and updated meter physical dimensions/power supply. Connectivity: standalone. Sterilization: not applicable (non-sterile). Software: embedded firmware for signal processing and glucose calculation.

Indications for Use

Indicated for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs.

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

• Rightest Glucose Monitoring System GM700 (k110737)
• Bionime Rightest Blood Glucose Monitoring System, Model GM650 (k120423)
• GE Talking Blood Glucose Monitoring System, Model GE300 (k120423)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k123008

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.) k110737 - Rightest Glucose Monitoring System GM700 and k120423 - Bionime Rightest Blood Glucose Monitoring System, Model GM650 and GE Talking Blood Glucose Monitoring System, Model GE300.

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 names of the devices have changed from Rightest Blood Glucose Monitoring System GM700 (k110737), Rightest Blood Glucose Monitoring System GM650 and GE Talking Blood Glucose Monitoring System, Model GE300" (k120423) to:
- Rightest Blood Glucose Monitoring System GM700
- GE200 Blood Glucose Monitoring System
- Rightest Blood Glucose Monitoring System GM650
- GE300 Talking Blood Glucose Monitoring System

B. Different percentage of test strip reagents

C. Change in concentrations of some substances at which interference is seen:
- Uric acid from 10 mg/dL to ≥ 16 mg/d
- Ascorbic acid from ≥ 6 mg/dL to ≥ 3 mg/dL,
- Dopamine HCl from ≥ 2.5 mg/dL to ≥ 1.25 mg/dL
- L-Dopa from ≥ 3 mg/dL to ≥ 2 mg/dL

D. Sample Volume from 1 μl to 0.75 μl

E. Changes in dimension and weight of meters

F. 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

{1}

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.

These devices are intended for single-patient use only. Efficacy of the Discide Ultra disinfecting towelettes with EPA registration #10492-4 was validated using hepatitis B surface antigen testing using materials from the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in the external materials of the meters and lancing device after 550 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 5 years of meter and lancing device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.