DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140

K061218 · Dade Behring, Inc. · JIX · Jun 30, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061218
• Device Name: DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The CHEM 4 CAL is an in vitro diagnostic product for the calibration of Albumin (ALB) and Total Protein (TP) methods on the Dimension Vista™ System.

Device Story

CHEM 4 CAL is a liquid, human serum-based calibrator kit for Albumin (ALB) and Total Protein (TP) assays. Used exclusively on the Dimension Vista™ System in clinical laboratory settings. Kit contains three vials of a single level; ready-to-use; no preparation required. Preserved with <0.1% sodium azide. System water serves as the zero calibrator. Value assignment involves spiking albumin into a human serum base, verified against IFCC CRM 470 (ALB) and NIST SRM 927 (TP) standards via replicate testing (N=90) across multiple instruments and reagent lots. Provides standardized reference points for the analyzer to ensure accurate patient sample quantification.

Clinical Evidence

No clinical data. Bench testing only. Value assignment verified using N=90 replicates across multiple reagent lots and instruments. Stability testing performed per CEN 13640.

Technological Characteristics

Human serum-based matrix; liquid form; contains <0.1% sodium azide. Traceable to IFCC CRM470 (Albumin) and NIST SRM 927 (Total Protein). Designed for use on Dimension Vista™ System. Risk management per ISO 14971:2000.

Indications for Use

Indicated for the calibration of Albumin (ALB) and Total Protein (TP) 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® TP/ALB Calibrator (k914917)

Submission Summary (Full Text)

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

A. 510(k) Number:
k061218

B. Purpose for Submission:
New device

C. Measurand:
Calibrator for Albumin (ALB) and Total Protein (TP)

D. Type of Test:
Not Applicable

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ System Chemistry Calibrator 4 (CHEM 4 CAL – KC140)

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Calibrator, Multi-Analyte Mixture (JIX) | Class II | 21 CFR 862.1150, Calibrator. | 75 CLINICAL CHEMISTRY (CH) |

H. Intended Use:

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

2. Indication(s) for use:
The CHEM 4 CAL is an in vitro diagnostic product for the calibration of Albumin (ALB) and Total Protein (TP) methods on the Dimension Vista™ System.

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3. Special conditions for use statement(s):

For Prescription use.

4. Special instrument requirements:

Dimension Vista™ System

I. Device Description:

The CHEM 4 CAL is an in vitro diagnostic product for the calibration of Albumin (ALB) and Total Protein (TP) methods on the Dimension Vista™ System. The kit consists of three vials of one level which are ready for use (no preparation is required). The volume per vial is 1.5 mL. System water is used as the TP and LAB zero calibrator (Level 1) for the Dimension Vista™ System. The vials contain sodium azide (less than 0.1%) as a preservative.

J. Substantial Equivalence Information:

Predicate Device: Dimension® TP/ALB Calibrator (DC31)

Predicate 510(k) Number(s): k914917

Comparison with Predicate:

| Comparison | | |
| --- | --- | --- |
| Item | New Device (k061218) | Predicate Device (k914917) |
| Intended Use | The CHEM 4 CAL is an in vitro diagnostic product for the calibration of Albumin (ALB) and Total Protein (TP) methods on the Dimension Vista™ System. | The CHEM 4 CAL is an in vitro diagnostic product for the calibration of Albumin (ALB) and Total Protein (TP) methods on the Dimension Vista™ System. |
| Analytes | Albumin (ALB) Total Protein (TP) | Albumin (ALB) Total Protein (TP) |
| Form | Liquid | Lyophylized |
| Traceability | ALB – IFCC CRM470 TP – NIST SRM 927 | ALB – IFCC CRM470 TP – NIST SRM 927 |
| Matrix | Human serum based product | Human serum based product |
| Number of Levels | One Level | Three Levels |

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

| STANDARDS |
| --- |
| Title and Reference Number |

CEN 13640 Stability testing of In-Vitro Diagnostic Devices

ISO 14971: 2000 Medical devices – Application of risk management to medical devices

| GUIDANCE | | |
| --- | --- | --- |
| Document Title | Office Division | Web Page |
| Guidance for Industry – Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final 02/22/1999 | | |
| Guidance for Industry and Staff – Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004 | | |

# 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):

**Value assignment:** The new calibrator is made by adding calculated quantities of albumin to the base matrix (human serum) which already contains total protein. The concentration is verified using an instrument calibrated with the primary and secondary standards. The final bottle assignment is assigned for the level of the commercial lot by testing N=90 replicates with multiple reagent lots on multiple instruments.

The assigned values of the ALB/TP calibrator are standardized to the following reference materials:

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| Analyte | Reference Material |
| --- | --- |
| Albumin | IFCC CRM 470 [i] |
| Total Protein | NIST SRM 927 [ii] |

[i] IFCC: International Federation for Clinical Chemistry
[ii] NIST: National Institute of Standards and Technology

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

4. Clinical cut-off:

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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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