NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH

K101633 · Nova Biomedical Corp. · JJY · Aug 27, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101633
• Device Name: NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
• Applicant: Nova Biomedical Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and β-Ketone test results.

Device Story

Nova Max Plus Glucose and β-Ketone Control Solutions serve as quality control material for blood glucose and β-ketone monitoring systems. The solutions are applied to compatible test strips; the monitor measures the electrochemical current generated by the reaction between the control solution and the strip reagents. The magnitude of the current is proportional to the concentration of glucose or β-hydroxybutyrate (β-ketone) in the sample. The device provides a quantitative check to verify system accuracy. Used by patients or healthcare providers in point-of-care or home settings to ensure monitor performance. Results are compared against expected ranges provided with the control solutions to confirm device functionality.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) support a 24-month shelf life and 90-day open-vial stability. Value assignment performed using 150 test results across multiple monitors and strip lots.

Technological Characteristics

Electrochemical sensing principle. Quantitative measurement of glucose or β-hydroxybutyrate. Two levels (Mid and High) provided. Compatible with Nova Max family monitors and specific test strips.

Indications for Use

Indicated for use as a quality control check to verify the accuracy of blood glucose and β-ketone test results in patients using Nova Max family monitors and compatible test strips. For in vitro diagnostic use.

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

• Nova Max Plus Blood Glucose and B-Ketone Monitor System (K091547)
• Nova Max Blood Glucose Monitor (K070255)

Submission Summary (Full Text)

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

A. 510(k) Number:
k101633

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for Blood Glucose and $\beta$-Ketone Monitoring Systems

D. Type of Test:
Quality Control Materials

E. Applicant:
Nova Biomedical Corporation

F. Proprietary and Established Names:
Nova Max Plus Glucose and $\beta$-Ketone Control Solutions

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 21 CFR 862.1660
Quality Control Material | Clinical Chemistry (75) |

H. Intended Use:

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

2. Indication(s) for use:
The Nova Max Plus Glucose and $\beta$-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose

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and β-Ketone test results.

3. Special conditions for use statement(s):

For *in vitro* diagnostic use only

For over the counter use

4. Special instrument requirements:

Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips.

I. Device Description:

The control solutions are aqueous assayed solutions containing Glucose and β-Ketone. There are two levels of controls (Level Mid and Level High).

The non-reactive formulation ingredients include: preservative, dye, and viscosity-adjusting agent.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Nova Max Plus Blood Glucose Control Solutions and Nova Max Plus Ketone Control Solutions

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

k091547

3. Comparison with predicate:

| Items | Nova Max Plus Glucose and β-Ketone Control Solutions (Candidate Device) | Nova Max Plus Glucose and β-Ketone Control Solutions (Predicate Device k091547) |
| --- | --- | --- |
| Intended Use | The Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and BD Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the | Same |

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| | accuracy of blood Glucose and β-Ketone test results. | |
| --- | --- | --- |
| Analyte(s) | Glucose and β-Ketone | Same |
| Levels of Controls | 2 | 3 |
| Target Concentration | Glucose: 106 mg/dL (Level Mid) 285 mg/dL (Level High) | Glucose: 62 mg/dL (Level Low) 121 mg/dL (Level Normal) 320 mg/dL (Level High) |
| | β-Ketone: 1.1 mM (Level Mid) 2.6 mM (Level High) | β-Ketone: 1.2 mM (Level 1) 2.9 mM (Level 2) 5.2 mM (Level 3) |
| Matrix | Preservative, dye, and viscosity-adjusting agent | Same |

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

None referenced

# 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

- Glucose controls are traceable to NIST (National Institute of Standards and Technology) D-Glucose SRM 917B.
- Nova Max Plus Ketone controls are traceable to an in house standard prepared gravimetrically from commercially available materials. No Standard Reference Material (SRM) is currently available for B-Hydroxybutyrate.

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Value Assignment:

- Glucose:
The target values are 106 mg/dL (Level Mid) and 285 mg/dL (Level High). The lot specific range was assigned as mean ± 17%. The Mean and SD was calculated from 150 test results (2 tests per strip lot per monitor per day, using 3 strip lots and 5 monitors over 5 days of testing).

- Ketone:
The target values are 1.1 mM (Level Mid) and 2.6 mM (Level High). The lot specific range was assigned as mean ± 20% for the high control, and mean ± 0.2 mM for the mid control. The Mean and SD was calculated from 150 test results (2 tests per strip lot per monitor per day, using 3 strip lots and 5 monitors over 5 days of testing).

Stability:

- Shelf life stability:
Real-time testing at room temperature (25°C) and accelerated testing at 40°C and 50°C were conducted. The stability study protocol and the acceptance criteria have been reviewed and found to be acceptable. The predicted shelf-life, based on results of accelerated testing, is 2.5 years at room temperature (25°C). Real-time stability testing is on-going to support the claimed shelf life of 24 months at room temperature (25°C).

- Open-Vial Stability:
The stability study protocol to determine open-vial stability of the controls and the acceptance criteria have been reviewed and found to be acceptable. The Nova Max Plus Glucose and β-Ketone Control Solutions are stable after opening for at least 90 days at room temperature (25°C).

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:

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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 vial labels.

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.