GLUCOSE METER-CHECK SOLUTION FOR TAIDOC

K131136 · Bionostics, Inc. · JJX · May 31, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131136
• Device Name: GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance and correct operation of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus.

Device Story

Glucose Meter-Check Solution is a buffered, aqueous, red-colored liquid control solution containing d-glucose and viscosity modifiers. It simulates whole blood properties to verify the performance of TaiDoc blood glucose meters and test strips. Used by healthcare professionals and patients with diabetes in clinical or home settings. The user applies the solution to a test strip; the meter performs an electrochemical measurement using glucose oxidase or glucose dehydrogenase enzymes. The result is compared against target ranges provided on the vial. This verification ensures the meter and strips are functioning correctly, aiding in accurate diabetes management.

Clinical Evidence

Bench testing only. Analytical performance was validated through traceability to NIST SRM 917 using YSI-supplied calibrators. Stability was confirmed via real-time studies (24-month shelf-life; 3-month open-vial stability). Value assignment was determined by measuring 8 samples on 5 meters across 3 lots of test strips (120 total measurements). Acceptance criteria for value assignment ranges were defined as mean ±15 mg/dL (for glucose < 80 mg/dL) or ±15% (for glucose ≥ 80 mg/dL).

Technological Characteristics

Buffered aqueous solution containing d-glucose, salts, viscosity modifiers, and preservatives. Red-colored for visibility. Packaged in LDPE vials with dropper tips. Analyte concentration optimized to simulate whole blood response for electrochemical glucose oxidase (GOD) or glucose dehydrogenase (GDH) test systems. Complies with ISO 15197:2003, ISO 14971:2009, and ISO 13485:2007 standards.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of TaiDoc Technology Corporation blood glucose meters and 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)

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# Decision Summary

Statement for the Record, k131136

This 510(k) was reviewed under OIR'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.