SMS GLUCOSE CONTROL, MODEL 2120061

K070649 · Spectrum Medical Supply, Inc. · JJX · Apr 12, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070649
• Device Name: SMS GLUCOSE CONTROL, MODEL 2120061
• Applicant: Spectrum Medical Supply, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

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 Home Diagnostics TrackEase Smart System and the TrueTrack Smart System Blood Glucose Monitors.

Device Story

SMS Glucose Control is a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. Packaged in plastic dropper-tipped bottles, the solution includes a red dye to assist users in visually confirming application to test strips. The device is used by healthcare professionals and patients with diabetes mellitus in clinical or home settings to verify the performance of specific blood glucose monitoring systems (TrackEASE Smart System and TrueTrack Smart System). Users apply the control solution to test strips as they would a blood sample; the resulting reading is compared against expected values to ensure the monitoring system is functioning correctly. This process helps ensure the accuracy of glucose measurements, supporting reliable diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Stability determined via real-time studies (24-month shelf-life; 90-day open-vial stability). Traceability established via repeat analysis using three lots of test strips to define acceptable ranges.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and red dye. Non-sterile, non-hazardous, no human/animal-derived materials. Form factor: 3.6 mL plastic dropper-tipped bottle. Storage: 36 °F to 86 °F. Standard referenced: CLSI EP5-A.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess performance of Home Diagnostics TrackEase Smart System and TrueTrack Smart System Blood Glucose Monitors.

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

• TrueTrack Smart System Glucose Control Level 0 (K030703)
• TrackEASE Smart System Glucose Control Level 0 (K042080)
• Liberty Glucose Control (K052980)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k070649

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for glucose

D. Type of Test:
Not applicable

E. Applicant:
Specialty Medical Supplies (SMS)

F. Proprietary and Established Names:
SMS Glucose Control

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJX, single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
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 Home Diagnostics TrackEase Smart System and the TrueTrack Smart System Blood Glucose Monitors.
2. Indication(s) for use:
See intended use section above.
3. Special conditions for use statement(s):
Over-The-Counter Use
4. Special instrument requirements:
Home Diagnostics TrackEase Smart System and the TrueTrack Smart System Blood Glucose Meters.

I. Device Description:
The product is a one-level, aqueous liquid glucose control solution for use with the Home Diagnostics TrackEase Smart System and the TrueTrack Smart System Blood Monitors. The glucose control consists of a buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, red dye, and other non-reactive ingredients. The device is non-sterile, non-hazardous and contains no human or animal derived materials.

{1}

The product is packaged in a plastic dropper tipped bottle for easy application of the control solution to the test strip and contains sufficient volume (3.6 mL) to run 75 tests. A red coloration is included to aid the user to visually confirm application of the control.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Home Diagnostics TrueTrack Smart System Glucose Control Level 0

2. Predicate 510(k) number(s):
k030703

3. Comparison with predicate:
Both devices contain D-Glucose and no human or animal derived materials.

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Target Population | Professional and home use | Professional and home use |
| Matrix | Buffered Aqueous Solution | Buffered Aqueous Solution |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Analytes | Glucose | Glucose |
| Number of Levels | 1 | 1 |

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

CLSI EP5-A, Evaluation of the Precision Performance of Clinical Chemistry Devices.

## 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):
The D-Glucose used in this control is traceable to an in-house glucose preparation. Values are assigned by repeat analysis using three different lots of test strips. The mean and standard deviation are used to establish the acceptable range for each control. A representative range of values for this product is 94 - 120 mg/dL.

Stability characteristics of the SMS Glucose Control were determined using real-time studies. The unopened shelf-life is 24 months and the open vial stability is 90 days at the recommended storage of 36 °F to 86 °F.

d. Detection limit:
Not applicable

{2}

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:
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:
Not applicable

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.