DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)

K062034 · Dade Behring, Inc. · JIX · Sep 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062034
• Device Name: DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System.

Device Story

Liquid, multi-analyte, human serum-based calibrator; contains Digoxin, Lithium, Phenobarbital, Phenytoin, and Theophylline. Used in clinical chemistry laboratories to calibrate specific assays on the Dimension Vista System. Kit consists of two levels (A and B) in six vials. Healthcare professionals use the calibrator to establish the relationship between instrument signal and analyte concentration; ensures accuracy of patient test results. Benefits include standardized, reliable quantification of therapeutic drugs and lithium levels, supporting clinical decision-making for drug monitoring and dosage adjustment.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed a 12-month shelf life, 31-day open-vial refrigerated stability, and 1-day on-board punctured vial stability. Traceability established via USP and NIST SRM standards.

Technological Characteristics

Liquid, human serum-based multi-analyte calibrator. Two levels. Traceability: Digoxin, Phenobarbital, Phenytoin, Theophylline to USP; Lithium to NIST SRM 924. Stability: 12-month shelf life; 1-day on-instrument punctured vial stability; 31-day refrigerated open-vial stability. Standards: CEN 13640 (stability), ISO 14971 (risk management).

Indications for Use

Indicated for the calibration of Digoxin, Lithium, Phenobarbital, Phenytoin, and Theophylline assays on the Dimension Vista™ System. For prescription 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® Drug Calibrator (k011035)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k062034

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator materials for Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO)

D. Type of Test:
Not Applicable

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista System Drug 1 Calibrator (DRUG 1 CAL - KC410)

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 indications(s) for use below.

{1}

2. Indication(s) for use:

The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System.

3. Special conditions for use statement(s):

For prescription use.

4. Special instrument requirements:

Dade Behring Dimension Vista™ System

I. Device Description:

DRUG 1 CAL is a liquid, multi-analyte, human serum based product containing digoxin, lithium, phenobarbital, phenytoin, and theophylline. 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). This same product, the Dimension Vista™ System Drug 1 Calibrator (KC410), was previously cleared (k051087) for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ System. The calibrator formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day. Each donor unit used in the preparation of this material was tested by FDA approved methods for the presence of antibodies to HIV-1, HIV-2, Hepatitis B Surface Antigen and antibody to HCV and found to be negative.

J. Substantial Equivalence Information:

| | Device | Predicate |
| --- | --- | --- |
| Item | Dimension Vista™ System Drug 1 Calibrator¹ | Dimension® Drug Calibrator (k011035) |
| Intended Use | The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System. | The Drug Calibrator is an in vitro diagnostic product to be used to calibrate the Digoxin (DGNA), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN), and Theophylline (THEO) methods on the Dimension® clinical chemistry system. |
| Analytes | Digoxin (DIG), Lithium (LI), Phenytoin (PTN), Theophylline (THEO), and Phenobarbital (PHNO)¹. | Digoxin (DGNA), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN), and Theophylline (THEO). |
| Form | Liquid | Liquid |
| Traceability | DIG, PHNO, PTN, THEO – USP². LI – NIST SRM³. | DIG, PHNO, PTN, THEO – USP². LI – NIST SRM³. |
| Matrix | Human serum based product | Human serum based product |
| Number of Levels | Two Levels | Five Levels |

{2}

^{1} The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension Vista™ System under k051087.
^{2} USP – United States Pharmacopeia.
^{3} NIST SRM – National Institute of Standards and Technology Standard Reference Material.

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

Standards:
CEN 13640 Stability testing of In-Vitro Diagnostic Devices

ISO 14971:2000 Medical devices -Application of Risk Management to Medical Devices

Guidance:
Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999

Guidance for Industry and FDA 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):
Traceability: The assigned values of the Drug 1 Calibrator are standardized to the enclosed table of assigned values:

| Analyte | Reference Material |
| --- | --- |
| Digoxin | USP² 120000 |
| Phenytoin | USP 1535507 |
| Theophylline | USP 1653004 |
| Lithium | NIST SRM³ 924 |
| Phenobarbital¹ | USP 1524001 |

¹ The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension Vista™

{3}

System under k051087

2 United States Pharmacopeia.
3 National Institute of Standards and Technology – Standard Reference Material.

Stability: The target life for the Dimension Vista™ Drug 1 Calibrator is 12 months. A vial punctured by the instrument and stored on board has a stability claim of one day. An open vial not on the instrument, but recapped and stored in the refrigerator had a stability claim of 31 days. 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:
Not applicable

{4}

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.

5