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

Intended 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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# K032574

## Summary of Safety and Effectiveness Information

### Dade Behring Dimension® Drug Calibrator II (DC49C)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.

| Submitter's Name: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | August 19, 2003 |
| Name of Product: | Dimension® Drug Calibrator II (DC49C) |
| FDA Classification Name: | Calibrator, drug mixture (91DKB) |
| Predicate Device: | Dimension® Drug Calibrator II (DC49B) [K990255]. |
| Device Description: | The predicate Drug Calibrator II product labeling is being modified to<br>include the assigned values for the additional N-acetylprocainamide<br>(NAPA) and procainamide (PROC) constituents.<br>The Dimension® Drug Calibrator II is a liquid, bovine serum base<br>product. It is packaged as ten vials, two vials at each of five levels.<br>Each vial contains 5.0 mL. |
| Intended Use: | The Dimension® Drug Calibrator II is an in vitro diagnostic<br>product intended for the calibration of the following methods<br>packaged in Dimension® Flex® reagent cartridges:<br>Acetaminophen (ACTM)<br>Carbamazepine (CRBM)<br>Digitoxin (DGTX)<br>Gentamicin (GENT)<br>N-acetylprocainamide (NAPA)<br>Procainamide (PROC)<br>Tobramycin (TOBR)<br>Valproic acid (VALP) |

#### Comparison to Predicate Device:

A summary of the features of the proposed Dade Behring Dimension® Drug Calibrator II (DC49C) product and the predicate Dimension® Drug Calibrator II product (DC49B) [K990255] is provided in the following chart:

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| Proposed<br>Dade Behring<br>Drug Calibrator II (DC49C) | | Current<br>Dade Behring<br>Drug Calibrator II (DC49B) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | For calibration of the following<br>nine (9) Dimension® Flex® methods: | For calibration of the following<br>seven (7) Dimension® Flex® methods: |
| | Acetaminophen (ACTM)<br>Carbamazepine (CRBM)<br>Digitoxin (DGTX)<br>Gentamicin (GENT)<br>N-acetylprocainamide (NAPA)<br>Procainamide (PROC)<br>Tobramycin (TOBR)<br>Valproic acid (VALP)<br>Vancomycin (VANC) | Acetaminophen (ACTM)<br>Carbamazepine (CRBM)<br>Digitoxin (DGTX)<br>Gentamicin (GENT)<br>Tobramycin (TOBR)<br>Valproic acid (VALP)<br>Vancomycin (VANC) |
| Matrix: | Bovine serum base | Bovine serum base |
| Form: | Liquid | Liquid |
| Package: | Ten vials -five levels,<br>two vials/level,<br>5.0 mL/vial | Ten vials - five levels,<br>two vials/level,<br>5.0 mL/vial |
| Value<br>Assignment: | USP standards or highest-order<br>purity material available | USP standards or highest-order<br>purity material available |

#### Comments on Substantial Equivalence:

Both the proposed Dade Behring Dimension® Drug Calibrator II (DC49B) and the existing Dade Behring Dimension® Drug Calibrator II (DC49B) [K990255] are in vitro diagnostic products intended as calibrators for the specified Dimension® Flex® methods on Dade Behring Dimension® clinical chemistry analyzer systems.

The only difference in the product offerings is that the proposed Dimension® Drug Calibrator II (DC49C) has value assignments for the calibration of the additional Dade Behring Dimension® N-acety|procainamide (NAPA) and Procainamide (PROC) Flex® reagent cartridge methods.

#### Conclusion:

Based on the same design, manufacture and intended use as described above, the multianalyte, five level, bovine serum base Dimension® Drug Calibrator II products (DC49C and DC49B) are substantially equivalent. The only difference is the assigned values for the two additional analytes (procainamide and n-acetylprocainamide).

> Richard M. Vaught Regulatory Affairs and Compliance Manager August 19, 2003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 6 2003

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: k032574

Trade/Device Name: Dimension® Drug Calibrator II (DC49C) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: August 19, 2003 Received: August 20, 2003

Dear Mr. Vaught:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT

Dimension® Drug Calibrator II (DC49C) Device Name:

#### 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)
RmVlVaught

hard M Venoht Regulatory Affairs and Compliance Manager

August 19, 2003

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-counter Use

(Optional format 1-2-96)

Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 32574

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