RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

K133522 · Bionime Coporation · NBW · Apr 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133522
• Device Name: RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
• Applicant: Bionime Coporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Bionime Rightest Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: Rightest Blood Glucose Monitoring System GM550 and GM250 with Rightest PC Link Adaptor (GP550), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (GP550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP650), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. The Bionime Rightest Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

Device Story

System facilitates transfer of blood glucose readings from compatible Bionime/GE meters to PC via USB or wireless (Bluetooth) PC link adapters. Software (Rightest/GE GP200) enables data visualization (tables, trend charts, pie charts) and report printing for diabetes management. Used by patients and healthcare professionals in home or clinical settings. Output aids in monitoring diabetes control; does not provide treatment decisions. Benefits include improved data organization and tracking of glucose trends over time.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing (data transmission accuracy, memory rollover synchronization) and a user performance evaluation (n=45) demonstrating that laypersons can successfully connect adapters and import data to the software. Readability assessment (Flesch-Kincaid) confirmed manuals are appropriate for 8th-grade reading level.

Technological Characteristics

System comprises glucose meters (electrochemical dehydrogenase sensor), PC link adapters (USB/Bluetooth), and management software. Meters use FAD-GDH or Glucose Oxidase reagents. Connectivity via USB or Bluetooth. Software runs on Windows (XP, Vista, 7).

Indications for Use

Indicated for patients with diabetes and healthcare professionals to manage diabetes by transferring, viewing, analyzing, and printing blood glucose data from compatible Bionime/GE meters. Not for treatment decisions, diagnosis, or screening.

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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k133522

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.