DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)

K062121 · Dade Behring, Inc. · DKB · Aug 25, 2006 · Clinical Toxicology

Device Facts

• Record ID: K062121
• Device Name: DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
• Applicant: Dade Behring, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista™ System.

Device Story

DRUG 2 CAL is a multi-analyte, liquid, bovine serum-based calibrator kit for the Dimension Vista™ System. It contains ten specific drug analytes. The kit includes two levels of calibrator (A and B). The system uses these to automatically prepare intermediate levels and calculate calibration values. It is used in clinical laboratory settings by trained personnel to calibrate diagnostic assays. The output is a calibrated instrument state, enabling accurate patient sample testing for therapeutic drug monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability testing performed per CEN 13640. Assigned values verified via N=20 replicates across multiple reagent lots and instruments.

Technological Characteristics

Liquid, bovine serum-based multi-analyte calibrator. Traceable to USP reference materials (except NAPA, which uses Alltech-Applied Sciences standards). Two-level configuration. Designed for automated dilution and calculation on the Dimension Vista™ System. Stability testing per CEN 13640; risk management per ISO 14971:2000.

Indications for Use

Indicated for the calibration of specific drug assays (ACTM, CRBM, DGTX, GENT, LIDO, NAPA, PROC, TOBR, VALP, VANC) on the Dimension Vista™ System for professional, prescription-only use.

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

• Dimension® Drug Calibrator II (K033809)

Submission Summary (Full Text)

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

A. 510(k) Number:
k062121

B. Purpose for Submission:
New device

C. Measurand:
Calibrator for acetaminophen, carbamazepine, digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide, tobramycin, valproic acid, and vancomycin assays.

D. Type of Test:
Not applicable. This submission is for clearance of a calibrator.

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ System Drug 2 Calibrator (DRUG 2 CAL – KC420)

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKB | II | 862.3200 | 91 |

H. Intended Use:

1. Intended use(s):
The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista™ System.

2. Indication(s) for use:

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The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) 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 2 CAL is a multi-analyte, liquid, bovine serum based product containing acetaminophen, carbamazepine, digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide, tobramycin, valproic acid, and vancomycin.

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). The volume per vial is 2.5 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

J. Substantial Equivalence Information:

| Predicate k033809 – Dade Behring Dimension Drug Calibrator II | | |
| --- | --- | --- |
| Comparison | | |
| Item | New Device | Predicate Device |
| Intended Use | DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen, carbamazepine, digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide, tobramycin, valproic acid, and vancomycin methods on the Dimension Vista™ System. | Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packaged in Flex reagent cartridges: acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC). |

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| Comparison | | |
| --- | --- | --- |
| Item | New Device | Predicate Device |
| Analytes | acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC). | acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC). |
| Form | Liquid | Liquid |
| Traceability | USP for all analytes except NAPA
NAPA - All-Tech Applied Sciences Reference Standard. | USP for all analytes except NAPA
NAPA - All-Tech Applied Sciences Reference Standard. |
| Matrix | Bovine | Bovine |
| Number of Levels | Two | Five |

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

| STANDARDS |
| --- |
| Title and Reference Number |
| Stability Testing of In Vitro Diagnostic Reagents (CEN 13640) |
| Medical devices - Application of risk management to medical devices (ISO 14971:2000) |
| GUIDANCE | | | |
| --- | --- | --- | --- |
| Document Title | Office | Division | Web Page |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | OIVD | | http://www.fda.gov/cdrh/ode/calibrator.html |
| Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use | | | http://www.fda.gov/cdrh/ocd/guidance/4444.html |

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L. Test Principle:

Not applicable. This submission is for calibrators.

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):

The new calibrator is prepared by adding calculated quantities of analytes to the base matrix (bovine serum). The concentration is verified using an instrument calibrated with the master calibrator pools. The final bottle assignment is assigned for the level of the commercial lot by testing N=20 replicates with multiple reagent lots on multiple instruments.

The assigned values of DRUG 2 CAL are traceable to USP Reference Materials except for NAPA which is traceable to All-Tech Applied Sciences Reference Standard.

Assigned values for a typical lot of DRUG 2 CAL is presented in the following table:

| Level | Units | ACTM | CRBM | DGTX | GENT | LIDO | NAPA | PROC | TOBR | VALP | VANC |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | ug/mL | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 5 | ug/mL | 302.1 | 22.0 | 83.0 | 11.6 | 12.5 | 33.4 | 21.2 | 13.4 | 164.1 | 48.6 |

The Calibrators are stable for 12 months when stored at 2 to 8 °C. A vial punctured by the instrument and stored on board the analyzer is stable for 24 hours. Opened vials stored at 2 to 8 °C are stable for 31 days. Protocols and acceptance criteria for stability testing were described and found to be acceptable.

d. Detection limit:

Not applicable.

e. Analytical specificity:

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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.

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.