DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

K062055 · Dade Behring, Inc. · JIX · Aug 7, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062055
• Device Name: DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Dimension Vista™ Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin/Transthyretin (PREALB) methods on the Dimension Vista™ System. The Dimension Vista™ Protein 1 Control L, M, and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin/Transthyretin (PREALB) methods on the Dimension Vista™ System.

Device Story

Dimension Vista™ Protein 1 Calibrator and Controls are liquid, human serum-based products; used for calibration and quality control of IGA, IGG, and Prealbumin assays on the Dimension Vista™ Integrated System. Calibrators establish assay traceability to ERM®-DA470 (CRM470); controls assess precision and analytical bias. Human source materials are screened for HIV-1/2, HbsAg, and HCV. Used by laboratory professionals in clinical settings to ensure accurate diagnostic testing.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Liquid, human serum-based multi-analyte products. Contains Immunoglobulin A, Immunoglobulin G, and Prealbumin. Designed for use on the Dimension Vista™ System. No specific materials of construction, energy sources, or software algorithms are described for the calibrator/control materials themselves.

Indications for Use

Indicated for use as calibrators and quality control materials for the assessment of IGA, IGG, and Prealbumin/Transthyretin levels on the Dimension Vista™ System in a clinical laboratory setting.

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 Vista™ Protein 1 Calibrator (k061338)
• Dimension Vista™ Protein 1 Control L (k061338)
• Dimension Vista™ Protein 1 Control M (k061338)
• Dimension Vista™ Protein 1 Control H (k061338)

Submission Summary (Full Text)

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

A. 510(k) Number:
k062055

B. Purpose for Submission:
510(k) premarket notification to manufacture and market the Dimension Vista™ Protein 1 Calibrator and the Dimension Vista™ Protein 1 Controls (Low, Medium, and High). The calibrator and controls have been modified to include Prealbumin.

C. Measurand:
Calibrators and Controls for Immunoglobulin A (IGA), Immunoglobulin G (IGG), Prealbumin (PREALB)

D. Type of Test:
Calibrators and Controls

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ Protein 1 Calibrator
Dimension Vista™ Protein 1 Control L
Dimension Vista™ Protein 1 Control M
Dimension Vista™ Protein 1 Control H

G. Regulatory Information:
1. Regulation section:
862.1150 – Calibrator
862.1660 – Quality control material (assayed and unassayed)

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2. Classification:
Class II (calibrator)
Class I, reserved (controls)

3. Product code:
calibrator, multi-analyte mixture (JIX)
multi-analyte controls, all kinds (assayed and unassayed) (JJY)

4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The Dimension Vista™ Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin/Transthyretin (PREALB) methods on the Dimension Vista™ System.

The Dimension Vista™ Protein 1 Control L, M, and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin/Transthyretin (PREALB) methods on the Dimension Vista™ System.

3. Special conditions for use statement(s):
For prescription use.

4. Special instrument requirements:
Dimension Vista™ Integrated System

I. Device Description:

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoglobulin A, Immunoglobulin G, and Prealbumin.

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Dimension Vista™ Protein 1 Control L, M, and H: Protein 1 Control L, M, and H are multi-analyte, liquid human based serum based products containing Immunoglobulin A, Immunoglobulin G, and Prealbumin.

All human source materials were tested by FDA approved methods and found to be negative for antibodies to HIV-1/2, HbsAg, and HCV.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension Vista™ Protein 1 Calibrator

Dimension Vista™ Protein 1 Control L

Dimension Vista™ Protein 1 Control M

Dimension Vista™ Protein 1 Control H

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

k061338

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Liquid, human serum | Liquid, human serum |
| Traceability to | ERM®-DA470
(CRM470) | ERM®-DA470
(CRM470) |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | IgA, IgG, prealbumin | IgA, IgG |

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

Not Applicable

## L. Test Principle:

Not Applicable

## M. Performance Characteristics (if/when applicable):

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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
The calibrator is traceable to ERM®-DA470 (CRM470).
Value Assignment
The calibrator master lot value is assigned vs. ERM®-DA470 (CRM470). The commercial calibrator lot value is assigned with three reference curves, 4 runs, 3 vials, 4 replicates per vial tested on two nephelometric instruments for a total of 144 values. The control values are assigned using the procedure outlined for the calibrators.
Stability
The calibrator and the controls follow the same stability protocol. Protocols and acceptance criteria 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:

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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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