GLUCOSE METER-CHECK SOLUTION FOR BAYER

K123966 · Bionostics, Inc. · JJX · Jan 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123966
• Device Name: GLUCOSE METER-CHECK SOLUTION FOR BAYER
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems: Bayer Contour Next blood glucose monitoring systems; Bayer Breeze 2 blood glucose monitoring systems; Bayer Contour and Contour TS blood glucose monitoring systems. Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.

Device Story

Glucose Meter-Check Solution is a viscosity-adjusted, aqueous liquid control solution used to verify the performance of specific Bayer blood glucose monitoring systems (BGMS). The solution is non-hazardous, contains no biological ingredients, and is dyed red to assist users in visual application onto test strips. It is intended for use by healthcare professionals and patients with diabetes mellitus in home or clinical settings. Users apply the solution to a test strip; the BGMS performs an enzymatic measurement of glucose. The resulting reading is compared against established target ranges to confirm the meter and test strip system are functioning correctly. This verification helps ensure the accuracy of blood glucose monitoring, supporting clinical decision-making for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Performance was verified by measuring the control solution on various Bayer BGMS (Breeze 2, Contour, Contour TS, Contour Next EZ) and comparing results to established target ranges. 100% of measurements fell within the specified assay ranges, meeting the acceptance criteria of at least 95% recovery.

Technological Characteristics

Viscosity-adjusted, aqueous glucose control solution. Ingredients: D-glucose (0.11% w/v), pH buffer, salt, viscosity modifier, preservative, and red dye. No biological components. Principle: Simulates whole blood response for enzymatic glucose measurement. Packaging: 6 mL white LDPE bottles with dropper tips. Shelf-life: 24 months unopened; 3 months opened. Standards: ISO 15197:2003, ISO 14971:2009, ISO 13485:2007, ISO 15223-1, ISO 18113-4, EN 13640.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to assess the performance of Bayer blood glucose monitoring systems (Contour Next, Breeze 2, Contour, and Contour TS).

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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Decision Summary, K123966

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.