GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM

K032819 · Bionostics, Inc. · JJX · Oct 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032819
• Device Name: GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose Monitoring System is intended for use to verify the performance of the Chdiagnostics Senova™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Device Story

Three-level (low, normal, high) viscosity-adjusted aqueous liquid glucose control solution; used to verify performance of CHdiagnostics SeNova Blood Glucose Monitoring System. Packaged in plastic bottles with dropper tips; blue-tinted for visibility during application to test strips. Target glucose values: 55, 140, and 330 mg/dL. Used by healthcare professionals and patients with diabetes at home. Provides quality control check for BGM system accuracy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Viscosity-adjusted, aqueous glucose control solution; three specific glucose concentrations; blue colorant; packaged in plastic bottles with dropper tips. Non-hazardous, non-biological. Optimized to simulate whole blood response on the Chdiagnostics Senova™ BGM system.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to verify performance of the CHdiagnostics SeNova Blood Glucose Monitoring System at glucose levels within the reportable range.

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.

Predicate Devices

• Multi-Meter Glucose Calibration Verification Material (K012430)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032819

B. Analyte:
Glucose

C. Type of Test:
N/A

D. Applicant:
Bionostics, Inc.

E. Proprietary and Established Names:
Glucose Control Solution for CHdiagnostics SeNova Blood Glucose Monitoring System

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1660
2. Classification:
Class I
3. Product Code:
JJX
4. Panel:
CH

G. Intended Use:
1. Indication(s) for use:
Glucose Control Solution for CHdiagnostics SeNova Blood Glucose Monitoring System is intended for use to verify the performance of the CHdiagnostics SeNova BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
2. Special condition for use statement(s):
N/A
3. Special instrument Requirements:
For use with the CHdiagnostics SeNOva Blood Glucose Monitoring System

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H. Device Description:

The Glucose Control Solution for CHdiagnostics SeNova Blood Glucose Monitoring System is a three level (low, normal and high), viscosity adjusted, aqueous liquid glucose control solution. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a blue color to help users see the solution while dispensing onto a test strip. The target values are 55, 140, and 330 mg/dL.

I. Substantial Equivalence Information:

1. Predicate device name(s):
Bionostics Multi-Meter Glucose Calibration Verification Material

2. Predicate K number(s):
K012430

3. Comparison with predicate:
Both devices are buffered, aqueous solutions of D-glucose that are manufactured using the same processes. They differ in that the predicate device has 5 levels and the subject device has three levels.

J. Standard/Guidance Document Referenced (if applicable):
N/A

K. Test Principle:
N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
N/A
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A

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b. Clinical specificity:
N/A

c. Other clinical supportive data (when a and b are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

**M. Conclusion:**
Based upon the information provided, I recommend that the Bionostics Glucose Control Solution for CHdiagnostics SeNova Blood Glucose Monitoring System be found substantially equivalent to predicate devices according to 21 CFR 1660.