DIMENSION TACR CALIBRATOR, MODEL DC107

K060503 · Dade Behring, Inc. · DLJ · May 18, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060503
• Device Name: DIMENSION TACR CALIBRATOR, MODEL DC107
• Applicant: Dade Behring, Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: May 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.

Device Story

Dimension® TACR Calibrator is a stabilized human whole blood hemolysate containing tacrolimus. It serves as a reference material for calibrating the Tacrolimus (TACR) assay on the Dimension clinical chemistry system. The kit includes five levels of calibrators with target concentrations of 0, 3, 6, 12, and 32.5 ng/mL. It is used in a clinical laboratory setting by trained laboratory personnel. By establishing a calibration curve, the device enables the clinical chemistry system to accurately quantify tacrolimus levels in patient samples, assisting healthcare providers in monitoring therapeutic drug levels.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (shelf-life and opened vial) supported by real-time data from three lots. Traceability established via LC/MS/MS.

Technological Characteristics

Stabilized human whole blood hemolysate. Five-level calibrator kit (0, 3, 6, 12, 32.5 ng/mL). Designed for use with the Dimension clinical chemistry system. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as a calibrator for the Tacrolimus (TACR) method on the Dimension clinical chemistry system. No specific patient population, age, or gender contraindications are provided.

Regulatory Classification

Identification

A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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

• Abbott IMx® Tacrolimus II Calibrators (P970007)

Submission Summary (Full Text)

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

A. 510(k) Number:
k060503

B. Purpose for Submission:
New device

C. Measurand:
Calibrator for Tacrolimus assay

D. Type of Test:
Not applicable - Calibrator

E. Applicant:
DADE BEHRING, INC.

F. Proprietary and Established Names:
DIMENSION TACR CALIBRATOR

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DLJ | II | 21 CFR 862.3200 | Toxicology (91) |

H. Intended Use:

1. Intended use(s):
The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.

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2. Indication(s) for use:

The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Dade Dimension clinical chemistry system

I. Device Description:

The Dimension TACR calibrator is a stabilized human whole blood hemolysate product containing tacrolimus. The kit consists of two vials of each calibrator level 1-5. The target concentrations are approximately 0, 3, 6, 12, and 32.5 ng/mL tacrolimus.

The calibrators contain human blood components. Each lot was tested and found to be non-reactive for Hepatitis B Surface Antigen (HBsAg), Antibodies to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), and Antibody to Hepatitis C Virus (HCV).

J. Substantial Equivalence Information:

| Predicate | | Abbott IMx Tacrolimus II Calibrator P970007 | |
| --- | --- | --- | --- |
| Similarities | | | |
| Item | Device | | Predicate |
| Intended use | Calibrators intended for use as a reference in measuring tacrolimus with their respective assays. | | Same |
| Matrix | Whole blood hemolysate | | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Target concentrations | 0, 3, 6, 12, and 32.5 ng/mL | 0, 3, 6, 12, 20, and 30 ng/mL |

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

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| GUIDANCE | | | |
| --- | --- | --- | --- |
| Document Title | Office | Division | Web Page |
| Class II Special Controls
Guidance Document:
Cyclosporine and Tacrolimus
Assays; Guidance for Industry
and FDA | OIVD | DCTD | http://www.fda.gov/cdrh/ode/guidance/1380.html |

L. Test Principle:

Not applicable - calibrator

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):

Purified tacrolimus powder and whole blood hemolysate and are used to prepare a stock solution. The master pool lots are prepared by diluting the stock to obtain specific target concentrations. The concentrations for the reference lot are assigned by LC/MS/MS. The target concentrations are approximately 0, 3, 6, 12, and 32.5 ng/mL tacrolimus.

Shelf-life and opened vial stability studies were conducted using real time data collected from three (3) lots of the TACR cartridge. The data from the sponsor's studies supported a shelf life of 12 months when the product is stored frozen (-15 to -25°C) and opened vial stability of 30 days when the product is stored at 2-8°C.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

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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):
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 is this premarket notification is complete and supports a substantial equivalence determination.