RIGHTEST CONTROL SOLUTION

K133003 · Bionime Corporation · JJX · Oct 24, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133003
• Device Name: RIGHTEST CONTROL SOLUTION
• Applicant: Bionime Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Rightest Control Solutions GC300 are for use with the Rightest Blood Glucose Meter GM300 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Control Solutions GC100 are for use with the Rightest Blood Glucose Meter GM100 and the Rightest Blood Glucose Test Strip GS100 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Control Solutions GC110 are for use with the Rightest Blood Glucose Meter GM110 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Control Solutions GC310 are for use with the Rightest Blood Glucose Meter GM310 and the Rightest Blood Glucose Test Strip GS310 to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Story

Rightest Control Solution is an aqueous glucose-based liquid; contains water, d-glucose, inorganic salt, dye, and preservative. Used as quality control material for blood glucose monitoring systems; verifies meter and test strip performance. User applies solution to test strip; meter reads glucose concentration; result compared to expected range on test strip vial. Used in home or clinical settings by patients or healthcare providers. Provides assurance of system accuracy; helps identify potential device malfunctions or improper testing technique.

Clinical Evidence

Bench testing only. Performance verified via value assignment procedure using three lots of control solutions and ten meters per test strip type. Stability demonstrated through real-time and accelerated studies, confirming 18-month closed-bottle shelf life and 3-month open-vial stability. Acceptance criteria defined as ±15% of mean value.

Technological Characteristics

Aqueous liquid containing water, d-glucose, inorganic salt, dye, and preservative. Single-level formulation. Red color for visibility. 4 mL net fill. Non-hazardous; no human/animal-derived materials. Shelf life: 1.5 years; open-vial stability: 3 months. Storage: 2-30°C.

Indications for Use

Indicated for use by patients and clinicians as a quality control material to verify the proper functioning of Rightest Blood Glucose Meters (GM100, GM110, GM300, GM310) and their corresponding test strips (GS100, GS300, GS310).

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

510(k) #: k133003

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.