FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3

K092645 · Fujirebio Diagnostics,Inc. · JJX · Sep 5, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092645
• Device Name: FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The FDI Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

Device Story

FDI Glucose Controls are buffered aqueous solutions containing D-Glucose, viscosity modifiers, preservatives, and red dye. Used by healthcare professionals and patients with diabetes to verify performance of TrueTrack®, TrackEASE®, and TRUEread™ glucose meters and test strips. Product is non-sterile, over-the-counter, and for external use only. User applies solution from a dropper-tipped bottle onto a test strip; meter reads result; user compares result against range printed on control vial label. Benefits include ensuring accuracy of glucose monitoring systems.

Clinical Evidence

No clinical data. Bench testing only. Stability established via accelerated shelf-life and open-vial studies (90 days). Traceability to NIST SRM 917c confirmed via reference clinical chemistry analyzer. Expected values determined by repeat analysis across multiple test strip lots.

Technological Characteristics

Buffered aqueous solution containing D-glucose, viscosity modifier, preservatives, and non-reactive ingredients. Form factor: plastic dropper-tipped bottle. Analyte: glucose. Levels: 3. Connectivity: None (standalone). Sterilization: Not specified.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of TrueTrack®, TrackEASE®, and TRUEread™ 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.

Predicate Devices

• TRUEcontrol Glucose Control Levels 0, 1, and 2 (K030703)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k092645

B. Purpose for Submission:
New Device

C. Measurand:
Quality control materials for TrueTrack®, TrackEase® and TRUEread™ whole blood glucose meters and test strips.

D. Type of Test:
QC Materials

E. Applicant:
Fujirebio

F. Proprietary and Established Names:
FDI Glucose Controls Levels 1, 2, and 3

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJX | Class I, reserved | 862.1660 | Chemistry 75 |

H. Intended Use:

1. Intended use(s):
Refer to indications for use below

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2. Indication(s) for use:

The FDI Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

3. Special conditions for use statement(s):

For in vitro diagnostic use (for external use only). For over the counter use.

4. Special instrument requirements:

TrueTrack®, TrackEASE® and TRUEread™ blood glucose test systems

I. Device Description:

The FDI Glucose Controls consist of three buffered aqueous solutions of D-Glucose, a viscosity modifier, preservatives, red dye, and other non-reactive ingredients. The devices are a non-sterile, over-the-counter product and are intended for external use only. They are non-hazardous and contain no human or animal derived materials. The solutions are packaged in a plastic dropper tipped bottle for easy application to the test strip and contain sufficient volume to run 75 tests. The red dye is included to aid the user to visually confirm application of the control.

J. Substantial Equivalence Information:

1. Predicate device name(s):

TRUEcontrol Glucose Control

2. Predicate 510(k) number(s)

k030703

3. Comparison with predicate

| Comparison Table | | |
| --- | --- | --- |
| Item | Predicate Device (k030703) | Candidate Device |
| Name | TRUEcontrol Glucose Control | FDI Glucose Controls |
| Indications for Use | To check the performance of the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips | To check the performance of the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips |

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| Analyte | Glucose | Glucose |
| --- | --- | --- |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Color | Red | Red |
| Fill Volume | 3.0 mL | 3.6 mL |
| Matrix | Water, D-glucose, buffers, viscosity enhancing agents, inorganic salts, amaranth, and preservatives. | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients |
| Target Population | Professional and home use | Professional and home use |
| Number of Levels | 3 | 3 |

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods, Second Edition 2004

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

The D-glucose used in these controls is traceable to an in-house standard prepared from NIST Standard Reference Material 917c. The control material is analyzed on the sponsor's reference analyzer and recovered values must fall within acceptance criteria based on the target value of the NIST standard.

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Expected Values

Glucose controls expected values were determined by repeat analyses using the sponsor’s reference clinical chemistry analyzer. Pre-determined acceptance criteria for glucose recovery must be met for each control lot. Acceptable ranges for the glucose values were determined using a TRUEread monitor and three different lots of TRUEread test strips, ten replicates per strip lot, over three days. Glucose control value ranges are lot dependent and are listed in the control vial label for each lot. Test results must fall within the range printed on the control vial. These ranges may differ from the range printed on the test strip vial. In the labeling, the user is directed to compare their control result with the range on the control vial label.

Stability

Stability characteristics of the FDI Glucose control solutions were determined using accelerated shelf-life studies and open vial studies. An unopened shelf-life of 24 months is expected at the recommended storage temperature of 36°F - 86°F. Open vial stability of 90 days was demonstrated when controls were stored at room temperature (36°F - 86°F).

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:

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Not applicable

b. Clinical specificity:
Not applicable

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

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
In the labeling the user is directed to compare their control result with the range on the control vial label. For level 1 the glucose values are expected to range from 88-112 mg/dL, for level 2 the values are expected to range from 184 – 242 mg/dL and for level 3 the values are expected to range from 355-456 mg/dL.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.