DIMENSION DRUG CALIBRATOR II, MODEL DC49C

K032574 · Dade Behring, Inc. · DKB · Oct 6, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032574
• Device Name: DIMENSION DRUG CALIBRATOR II, MODEL DC49C
• Applicant: Dade Behring, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Oct 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Dade Behring Dimension® Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges: Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic acid (VALP) Vancomycin (VANC)

Device Story

Liquid, bovine serum-based calibrator; used on Dade Behring Dimension clinical chemistry analyzer systems. Provides reference points for quantitative measurement of therapeutic drugs in human specimens. Product consists of ten vials across five levels. Healthcare providers use calibrator to establish assay curves for Flex reagent cartridges; ensures accuracy of patient drug concentration results. Facilitates clinical decision-making regarding therapeutic drug monitoring and dosage adjustments.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bovine serum base; liquid form; ten vials (five levels, two vials/level, 5.0 mL/vial). Value assignment based on USP standards or highest-order purity material available. Used as a calibrator for clinical chemistry analyzer systems.

Indications for Use

Indicated for use as a multi-level calibrator for the Dade Behring Dimension® clinical chemistry system to establish reference points for measuring Acetaminophen, Carbamazepine, Digitoxin, Gentamicin, N-acetylprocainamide, Procainamide, Tobramycin, Valproic Acid, and Vancomycin in human specimens. Prescription use only.

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 (K990255)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032574

B. Analyte:
Calibrators for the measurement of Acetaminophen, Carbamazepine, Digitoxin, Gentamicin, N-acetylprocainamide, Procainamide, Tobramycin, Valproic Acid, and Vancomycin.

C. Type of Test:
N/A (calibrators only)

D. Applicant:
Dade Behring, Inc.

E. Proprietary and Established Names:
Dade Behring Dimension® Drug Calibrator II

F. Regulatory Information:
1. Regulation section:
CFR 862.3200
2. Classification:
Class II
3. Product Code:
DKB
4. Panel:
Clinical Toxicology

G. Intended Use:
1. Indication(s) for use:
The Dade Behring Dimension® Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges:

Acetaminophen (ACTM)
Carbamazepine (CRBM)
Digitoxin (DGTX)
Gentamicin (GENT)
N-acetylprocainamide (NAPA)
Procainamide (PROC)
Tobramycin (TOBR)
Valproic Acid (VALP)
Vancomycin (VANC)

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2. Special condition for use statement(s):
Prescription Use Only

3. Special instrument Requirements:
Dade Behring Dimension® Clinical Chemistry System

H. Device Description:
Dade Behring Dimension® Drug Calibrator II is a 5 level multi-drug calibrator for Acetaminophen, Carbamazepine, Digitoxin, Gentamicin, N-acetylprocainamide, Procainamide, Tobramycin, Valproic Acid, and Vancomycin. It is packaged as ten vials (5.0 mL each), two vials at each of five levels.

I. Substantial Equivalence Information:

1. Predicate device name(s):
Dimension® Drug Calibrator II

2. Predicate K number(s):
K990255

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes Included | For the calibration of: Acetaminophen, Carbamazepine, Digitoxin, Gentamicin, N-acetylprocainamide, Procainamide, Tobramycin, Valproic Acid, and Vancomycin | Same as device minus Procainamide and N-acetylprocainamide |
| Matrix | Bovine serum base | Same |
| Form | Liquid, ready-to-use | Same |
| Packaging | Ten vials: two vials at five levels (5.0 mL each) | Same |
| Value Assignment | USP standards or highest-order purity material available used for anchor lot – commercial product compared to anchor lot | Same |

J. Standard/Guidance Document Referenced (if applicable):
None referenced

K. Test Principle:
N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A

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c. Traceability (controls, calibrators, or method):
In – house reference (anchor) lot. Each analyte is traceable to USP drug standard or highest order purity available.

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

M. Conclusion:

Based upon the information provided for the file, I recommend that the Dade Behring Dimension® Drug Calibrator II is substantially equivalent to the predicate device.

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