DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130

K062334 · Dade Behring, Inc. · JIX · Sep 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062334
• Device Name: DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 22, 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), ammonia (AMON), and carbon dioxide (CO2) methods on the Dimension Vista™ System.

Device Story

Dade Behring Dimension Vista™ Chemistry 3 Calibrator is a multi-analyte, aqueous, ready-to-use liquid product; contains ethyl alcohol, ammonium bicarbonate, and sodium carbonate. Used in clinical laboratory settings to calibrate alcohol, ammonia, and carbon dioxide assays on the Dimension Vista™ System. Calibrator values are assigned via gravimetric preparation and verification against Master Pools using multiple instruments. Provides standardized reference points for clinical chemistry analyzers to ensure accurate patient sample quantification. Benefits patient care by maintaining assay accuracy for critical analytes.

Clinical Evidence

No clinical data. Bench testing only. Stability testing performed per ISO 13640; shelf-life stability verified by comparing 4°C storage against -20°C control. Value assignment verified using N=45 replicates per level across multiple instruments.

Technological Characteristics

Aqueous multi-analyte solution. Analytes: Ethyl alcohol (USP grade), ammonium bicarbonate (ACS grade), sodium carbonate. Traceability: USP, ACS, and NIST SRM 351. Form: Liquid, ready-to-use. Stability: 12-month shelf life; 24-hour on-board stability; 30-day open-vial stability at 2-8°C. Risk management per ISO 14971:2000.

Indications for Use

Indicated for the calibration of alcohol, ammonia, and carbon dioxide methods on the Dimension Vista System for 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® AMON Calibrator (K863840)
• 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:
k062334

B. Purpose for Submission:
Notification of intent to manufacture and market a new device

C. Measurand:
Alcohol, Ammonia, Carbon Dioxide

D. Type of Test:
Calibrator

E. Applicant:
DADE BEHRING, INC.

F. Proprietary and Established Names:
Proprietary name – DADE Behring Dimension Vista™ Chemistry 3 Calibrator
Established Name – Calibrator

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

H. Intended Use:

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

2. Indication(s) for use:

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

3. Special conditions for use statement(s):

None

4. Special instrument requirements:

None.

I. Device Description:

The DADE Behring Dimension Vista™ Chemistry 3 Calibrator is a multi-analyte, aqueous product containing ethyl alcohol, ammonium bicarbonate 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:

1. Predicate device name(s):

Dade Behring Dimension Ammonia Calibrator, Dade Behring Dimension ECO2 Calibrator, and Dade Behring Dimension Alcohol Calibrator

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

K863840, k010208, and k904308 respectively

3. Comparison with predicate:

| | New Device | Predicate | Predicate | Predicate |
| --- | --- | --- | --- | --- |
| Item | DADE Behring Dimension Vista™ Chemistry 3 Calibrator | Dade Behring Dimension Ammonia Calibrator | Dade Behring Dimension Alcohol Calibrator | Dade Behring Dimension ECO2 Calibrator, |

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| Intended Use | The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2) methods on the Dimension Vista™ System. | The Ammonia Calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON) on the Dimension Clinical Chemistry System. | The Alcohol Calibrator is an in vitro diagnostic product for the calibration of Alcohol (ALC) on the Dimension Clinical Chemistry System. | The ECO2 Calibrator is an in vitro diagnostic product for the calibration of Enzymatic Carbonate (ECO2) on the Dimension Clinical Chemistry System. |
| --- | --- | --- | --- | --- |
| Analytes | Alcohol (ALC), Ammonia (AMON) and Carbon Dioxide (CO2) | Ammonia | Alcohol | Carbon Dioxide |
| Form | Liquid | Liquid | Liquid | Liquid |
| Traceability | ALC - USP¹ Grade Ethyl Alcohol ACS² Grade AMON - Ammonium Sulfate CO2 - NIST SRM³ 351 | ACS² - Ammonium Sulfate | ALC - USP¹ Grade Ethyl Alcohol | CO2 -NIST SRM³ 351 |
| Matrix | Aqueous | Aqueous | Aqueous | Aqueous |
| Number of Levels | 2 | 3 | 4 | 3 |

¹ United States Pharmacopeia
² American Chemical Society
³ National Institutes of Standards and Technology Standard Reference Material

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

| STANDARDS |
| --- |
| Title and Reference Number |
| Stability Testing of In Vitro Diagnostic Reagents (13640) |
| Medical devices - Application of risk management to medical devices (14971:2000) |

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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

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):

Assigned values are standardized to the materials in the table below:

| Analyte | Reference Material |
| --- | --- |
| Alcohol | USP^{1} Grade Ethyl Alcohol |
| Ammonia | ACS^{2} Grade Ammonium Sulfate |
| Carbon Dioxide | NIST SRM^{3} 351 |

1. United States Pharmacopeia
2. American Chemical Society
3. National Institutes of Standards and Technology Standard Reference Material

Reference materials are weighed into water and stored at appropriate

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temperatures. Master Pool values are verified by comparing against previously approved Master Pool values. The stock solution is made by adding alcohol, ammonia and carbon dioxide reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified on an instrument calibrated with a previously approved Master Pool. The commercial lot is made by adding calculated quantities of stock solution to purified water in appropriate concentrations for each of the calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools. The final bottle values for each level of the commercial lot is assigned using multiple instruments by testing N = 45 replicates per level.

Stability:

Target shelf life for the Dimension Vista™ System Chemistry 3 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 5%. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. A vial punctured by the instrument and stored on board is stable for 24 hours. An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days.

For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 – 8 °C. Opened/punctured vials are tested on days 1, 3, and 32 versus freshly opened vials.

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:

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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