FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

K123612 · Fujirebio Diagnostics,Inc. · JJX · Jan 17, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123612
• Device Name: FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.

Device Story

FDI Glucose Control Solution is a viscosity-adjusted, aqueous liquid containing a known quantity of glucose; includes red dye for visual confirmation of application. Used by professionals and patients in home settings to verify performance of Accu-Chek Aviva blood glucose meters and Aviva Plus test strips. User applies control solution to test strip; meter reads glucose concentration; user compares result to target range printed on vial label. Ensures system accuracy; helps prevent erroneous blood glucose readings. Non-hazardous; no human/animal-derived materials.

Clinical Evidence

Bench testing only. Real-time stability study supports 24-month shelf life at 15-30°C. Open-vial stability study supports 90-day usage. Value assignment performed using a single Accu-Chek Aviva monitor across three test strip lots; traceability established to NIST SRM 917b.

Technological Characteristics

Aqueous liquid control solution; contains D-Glucose, viscosity modifier, buffer, salt, preservatives, and FD&C Red #40. Packaged in plastic dropper-tipped bottles. Traceable to NIST SRM 917b. No electronic components or software.

Indications for Use

Indicated for professional and home use to verify proper function of the Accu-Chek Aviva blood glucose meter and Aviva Plus test strips.

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)

{0}

Decision Summary, k123612

This 510(k) was reviewed under OIVD’s Pilot Triage 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.