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

{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.