DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210

K072717 · Dade Behring, Inc. · JIT · Dec 12, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072717
• Device Name: DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.

Device Story

BILI CAL is a two-level calibrator for the Dimension Vista® System; used to calibrate Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) assays. Level 1 consists of on-board purified system water; Level 2 is a liquid, bovine serum albumin-based material spiked with ditaurobilirubin. Traceable to NIST Standard Reference Material 916a. Used in clinical laboratory settings by laboratory technicians to ensure accuracy of bilirubin measurements. Output is used by the analyzer to establish calibration curves for patient sample testing, aiding clinicians in the diagnosis and monitoring of liver and biliary conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Two-level calibrator. Level 1: purified system water. Level 2: bovine serum albumin-based liquid spiked with ditaurobilirubin. Traceable to NIST SRM 916a. Designed for use on the Dimension Vista® System.

Indications for Use

Indicated for the calibration of Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) 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 Vista™ TDBIL Calibrator (k061839)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k072717

B. Purpose for Submission:
New device

C. Measurand:
Calibrator material for direct and total bilirubin

D. Type of Test:
Calibrator material

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista® System BILI Calibrator

G. Regulatory Information:
1. Regulation section:
21§ 862.1150 - Calibrator
2. Classification:
Class II
3. Product code:
JIT
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):

See indication(s) for use below.

2. Indication(s) for use:

The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

For use on the Dade Behring Dimension Vista® System

I. Device Description:

The BILI calibrator is a two level calibrator material. Level 1 calibrator is purified system water, which is provided on-board the Dimension Vista® and contains no bilirubin. Level 2 is a liquid, bovine serum albumin based material spiked with ditaurobilirubin and traceable to NIST Standard Reference material 916a.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension Vista™ TDBIL Calibrator

2. Predicate K number(s):

k061839

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The BILI CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System | Same |
| Traceability | NIST Standard Reference Material (SRM) 916a | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Ditaurobilirubin | Same |
| Levels | Level 1 is on-board, purified system water; Level 2 Total Bilirubin 27.5 mg/dL | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Bovine Serum | Human Serum |
| Levels | Direct Bilirubin Level 2 is 17.5 mg/dL | Direct Bilirubin Level 2 is 19.25 mg/dL |
| Form | Liquid | Lyophilized |
| Volume | 3 vials, 2.5 mL each | 3 vials, 1 mL each |

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

FDA Guidance: Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators, 2/22/98

## 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 calibrator is traceable to NIST SRM 916a. The values are assigned by spiking master serum pools with varying amount of ditauroibilirubin and analyzing repeated measurements on the instrument calibrated with NIST material. Then the working bovine serum calibrator material is prepared by spiking with ditauroibilirubin and analyzing repeated measurements for total and direct bilirubin on the instrument calibrated with the master pools.

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# Stability:

Opened-unopened stability, freeze-thaw stability, real-time stability, and accelerated stability studies were performed and found to meet the sponsor's acceptable criteria.

# Expected values:

The assigned value is provided in the labeling.

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:

A total of 35 plasma samples and 32 serum samples were assayed on the instrument in duplicate to compare the results of the proposed calibrator material on the y axis with the current calibrator material on the x axis. The results yielded the following linear regression equations:

| Method | Slope | Intercept | Correlation coefficient | N |
| --- | --- | --- | --- | --- |
| Total bili | 1.004 | -0.010 | 1.000 | 67 |
| Direct bili | 0.981 | -.035 | 0.999 | 67 |

b. Matrix comparison:

Not applicable

# 3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

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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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