DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)

K062122 · Dade Behring, Inc. · JIX · Aug 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062122
• Device Name: DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC) and carbon dioxide (CO2) methods on the Dimension Vista™ System.

Device Story

Dimension Vista System Chemistry 3 Calibrator (CHEM 3 CAL) is a multi-analyte, aqueous, liquid-form product; contains ethyl alcohol and sodium carbonate. Used to calibrate alcohol and carbon dioxide methods on the Dimension Vista clinical chemistry system. Kit includes six vials (three of Calibrator A, three of Calibrator B). Operates by providing known concentrations of analytes to establish calibration curves on the instrument. Used by laboratory professionals in clinical settings. Benefits patient by ensuring accuracy and reliability of diagnostic test results for alcohol and CO2 levels.

Clinical Evidence

No clinical data. Bench testing only. Stability testing performed per CEN 13640; calibrators stable for 12 months at 2-8°C, 31 days opened at 2-8°C, and 24 hours on-board the analyzer. Value assignment verified via N=45 replicates.

Technological Characteristics

Aqueous solution containing ethyl alcohol and sodium carbonate. Traceability: USP Grade Ethyl Alcohol and NIST SRM 351. Form: Liquid. Storage: 2 to 8 °C. Designed for use with Dade Behring Dimension Vista System.

Indications for Use

Indicated for the calibration of alcohol and carbon dioxide methods on the Dimension Vista System for professional in vitro diagnostic use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® ALC Calibrator (K904308)
• Dimension® ECO2 Calibrator (K010208)

Submission Summary (Full Text)

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

A. 510(k) Number:
k062122

B. Purpose for Submission:
New device

C. Measurand:
Calibrator materials for Alcohol and Carbon Dioxide assays

D. Type of Test:
Not applicable. This submission is for clearance of calibrator materials

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ System Chem 3 Calibrator (CHEM 3 CAL - KC130)

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIX | II | 21 CFR 862.1150 | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC) and carbon dioxide (CO2) methods on the Dimension Vista™ System.

2. Indication(s) for use:
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC) and carbon dioxide (CO2) methods on the Dimension Vista™ System.

3. Special conditions for use statement(s):

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For prescription use

4. Special instrument requirements:

Dade Behring Dimension Vista System

I. Device Description:

CHEM 3 CAL is a multi-analyte, aqueous product containing ethyl alcohol and sodium carbonate. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL.

J. Substantial Equivalence Information:

| Predicate | k904308 – Dade Behring Dimension
ALC Calibrator | | |
| --- | --- | --- | --- |
| Predicate | k010208 – Dade Behring Dimension
ECO2 Calibrator | | |
| Comparison | | | |
| Item | New Device | Predicate (ALC Calibrator) | Predicate (ECO2 Calibrator) |
| Intended Use | The CHEM CAL 3 is an in vitro diagnostic product for the calibration of Alcohol (ALC) and Carbon Dioxide (CO2) methods on the Dimension Vista™ System | The Alcohol Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension clinical chemistry system for the Ethyl Alcohol (ALC) method. | The Dimension ECO2 Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension clinical chemistry system for the Enzymatic Carbonate (ECO2) method. |
| Analytes | Alcohol and carbon dioxide | Alcohol | Carbon Dioxide |
| Form | Liquid | Liquid | Liquid |
| Traceability | ALC – USP Grade Ethyl Alcohol
CO2 – NIST SRM 351 | USP Grade Ethyl Alcohol | NIST SRM 351 |
| Number of Levels | Two | Four | Three |

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

| STANDARDS |
| --- |
| Title and Reference Number |
| Stability Testing of In Vitro Diagnostic Reagents (CEN 13640) |
| Medical devices - Application of risk management to medical devices (ISO 14971:2000) |
| Other Standards | | | |
| --- | --- | --- | --- |
| GUIDANCE | | | |
| Document Title | Office | Division | Web Page |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | OIVD | | http://www.fda.gov/cdrh/ode/calibrator.html |
| Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use | | | http://www.fda.gov/cdrh/ocd/guidance/4444.html |

L. Test Principle:

Not applicable. This submission is for calibrator materials.

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 calibrator is prepared by adding calculated quantities of analytes into purified water. The concentration is verified using an instrument calibrated with the master calibrator pools. The final bottle assignment is assigned for the level of the commercial lot by testing N=45 replicates with multiple reagent lots on multiple instruments.

The assigned values of the alcohol are traceable to USP Grade Alcohol and of the Carbon Dioxide are traceable to NIST SRM 351.

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The calibrator materials are stable for 12 months when stored at 2 to 8 °C. A vial punctured by the instrument and stored on board the analyzer is stable for 24 hours. Opened vials stored at 2 to 8 °C are stable for 31 days. Protocols and acceptance criteria for stability testing were described and found to be acceptable.

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

4. Clinical cut-off:
Not applicable.

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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.

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