CONTREX PLUS LOW CONTROL SOLUTION

K100747 · Apex BioTechnology Corp. · JJX · Apr 14, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100747
• Device Name: CONTREX PLUS LOW CONTROL SOLUTION
• Applicant: Apex BioTechnology Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The purpose of the control solution test is to validate the performance of the GlucoSure STAR and Gluco TRACK Blood Glucose Monitoring Systems using a test solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Device Story

Contrex Plus Low Control Solution is an aqueous quality control material containing D-glucose; used to verify performance of GlucoSure STAR and GlucoTRACK blood glucose monitoring systems. Users (patients or clinicians) apply solution to test strips; meter measures glucose concentration. If result falls within assigned range (40-70 mg/dL), system and user technique are confirmed functional. Used in home or clinical settings to ensure accuracy of blood glucose monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time, opened/unopened) confirmed 2-year shelf life and 90-day open-vial stability. Expected values (55 mg/dL ± 15 mg/dL) validated using GlucoSure STAR meters and test strips over 10 days.

Technological Characteristics

Aqueous solution of D-glucose, buffers, stabilizer, and preservative. 2.5 mL fill volume. Packaged in plastic bottle with dropper-tip and white cap. Standalone quality control material. No energy source or software.

Indications for Use

Indicated for users of GlucoSure STAR and GlucoTRACK Blood Glucose Monitoring Systems to validate system performance and user technique via a known glucose concentration 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

• Gluco Track Blood Glucose Monitoring System (k062799)

Submission Summary (Full Text)

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

A. 510(k) Number:
k100747

B. Purpose for Submission:
New glucose control level

C. Measurand:
Quality control material for GlucoSure STAR and Gluco TRACK whole blood glucose monitoring systems

D. Type of Test:
Quality Control Materials

E. Applicant:
Apex BioTechnology Corporation

F. Proprietary and Established Names:
Contrex Plus Low Control Solution

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJX | Class I, reserved | 862.1660 | Clinical Chemistry |

H. Intended Use:

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

2. Indication(s) for use:
The purpose of the control solution test is to validate the performance of the GlucoSure STAR and Gluco TRACK Blood Glucose Monitoring Systems using a test solution with a known range of glucose. A control test that falls within the

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acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

3. Special conditions for use statement(s):

For in vitro diagnostic use

For over the counter use

4. Special instrument requirements:

GlucoSure STAR or Gluco TRACK blood glucose monitoring systems

I. Device Description:

The Contrex Plus Low Control solution consists of an aqueous solution of D-glucose. Non-reactive formulation ingredients include: buffers, stabilizer, and preservative.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Gluco Track Blood Glucose Monitoring System (includes glucose control solutions)

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

k062799

3. Comparison with predicate:

| | Candidate Device: Contrex Plus Low Control Solution | Predicate Device: Contrex Plus Level 1 and Level 2 Control solutions from Gluco Track Blood Monitoring System (k062799) |
| --- | --- | --- |
| Indications for Use | To check the performance of the GlucoSure STAR and Gluco Track blood glucose monitoring systems | Same |
| Testing system | GlucoSure STAR & Gluco Track | Gluco Track |
| Analyte | D-glucose | Same |

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| | Candidate Device: Contrex Plus Low Control Solution | Predicate Device: Contrex Plus Level 1 and Level 2 Control solutions from Gluco Track Blood Monitoring System (k062799) |
| --- | --- | --- |
| Matrix | aqueous | Same |
| Fill volume | 2.5 mL | Same |
| Color | Transparent | Same |
| Container | Plastic bottle with dropper-tip and white cap | Same but with green cap for Level 1 and blue cap for Level 2 |
| Number of Level(s) | 1 | 2 |
| Target Ranges | (40 - 70 mg/dL) | (87 – 131 mg/dL)
(186 – 280 mg/dL) |

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

No standard/guidance documents were referenced in this submission.

# 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

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The sponsor claims traceability of the D-glucose used in this control to the Glucose Standard Set NERL 1343: 50, 100, 200, and 400 mg/dL.

## Expected Values

Glucose control expected values were determined by repeat analyses using the GlucoSure STAR meter, one lot of Contrex Plus Low Control Solution, and 80 GlucoSure STAR test strips. The mean value was 55 mg/dL glucose and a ± 15 mg/dL range was assigned. Value assignment was validated with two GlucoSure STAR meters, one lot of GlucoSure STAR test strips, over 10 days using two strips per test run. Test results must fall within the range printed on the test strip vial. The expected results may change with each new lot. However, the control range is listed on the test strip vial. In the package insert, the user is directed to compare their control result with the range printed on the test strip vial.

The applicant also provides values for the Gluco Track system since this is the same device as the GlucoSure STAR (k073648) except for alternate site testing (AST) claim.

## Stability

Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Stability characteristics of the Contrex Plus Low Control Solution were determined using real time un-opened and opened vial studies. An unopened shelf-life of 2 years (24 months) is expected at the recommended storage temperature (59°F-86°F). Open vial stability of 90 days (3 months) was demonstrated at the recommended storage temperature of 59°F-86°F. The recommendations in the labeling are to store control solutions at room temperature and additional warnings are given to not freeze or refrigerate control solutions.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

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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:
Expected values are provided on the test strip vials

N. Proposed Labeling:
The labeling is sufficient and 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.