DIMENSION DRUG CALIBRATOR II, MODEL DC49B

K990255 · Dade Behring, Inc. · DKB · Feb 16, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990255
• Device Name: DIMENSION DRUG CALIBRATOR II, MODEL DC49B
• Applicant: Dade Behring, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Feb 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

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) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)

Device Story

Dimension® Drug Calibrator II is a liquid, bovine serum-based calibrator kit; used in clinical laboratories to calibrate specific drug assays (acetaminophen, carbamazepine, digitoxin, gentamicin, tobramycin, valproic acid, vancomycin) packaged in Flex™ reagent cartridges. The product provides five levels of calibration to establish the relationship between instrument signal and analyte concentration. Healthcare providers use the resulting calibration curves to ensure the accuracy of patient drug level measurements performed on the Dimension® system. This calibration process is essential for reliable therapeutic drug monitoring and clinical decision-making regarding patient dosing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid bovine serum-based calibrator; five levels; 5.0 mL per vial. Uses USP Digitoxin as a primary standard for digitoxin calibration. Designed for use with Flex™ reagent cartridges on the Dimension® system.

Indications for Use

Indicated for the calibration of in vitro diagnostic assays for acetaminophen, carbamazepine, digitoxin, gentamicin, tobramycin, valproic acid, and vancomycin in clinical laboratory settings.

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

• aca® Digitoxin Calibrator (K891093)

Submission Summary (Full Text)

{0}------------------------------------------------

2/16/99

K990255

## Dade Behring

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

## Summary of Safety and Effectiveness Information

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

| Submitter's Name: | Cathy P. Craft<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | January 22, 1999 |
| Name of Product: | Dimension® Drug Calibrator II |
| FDA Classification Name: | Calibrator |
| Predicate Device: | aca® Digitoxin Calibrator, K891093 |

Device Description: The Dimension® Drug Calibrator II is a liquid bovine serum-based product. The kit consists of ten vials; two at each of five levels.

Intended use: 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) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)

## Comparison to Predicate Device:

| Item | aca® Digitoxin Calibrator | Dimension® Drug Calibrator II |
|---------------------|--------------------------------------|-----------------------------------------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analytes | digitoxin | digitoxin, acetaminophen,<br>carbamazepine, gentamicin,<br>tobramycin, vancomycin |
| Matrix | human serum base | bovine serum base |
| Form | lyophilized | liquid |
| Volume | 3.0 mL per vial, reconstituted | 5.0 mL per vial |
| Levels | 3 levels | 5 levels |
| Digitoxin Reference | Primary standard --<br>USP Digitoxin | Primary standard -<br>USP Digitoxin |

{1}------------------------------------------------

Comments on Substantial Equivalence: Both the aca® Digitoxin Calibrator and the Dimension® Drug Calibrator II are intended to be used as calibrators for digitoxin methods.

Conclusion: The Dimension® Drug Calibrator II is substantially equivalent to the aca® Digitoxin Calibrator based on the comparison discussed above.

C

Cathy P. Craft

ﺘﺘﺒﺮ: ﻧ 、

Regulatory Affairs and Compliance Manager Date: January 22, 1999

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 6 1999

Cathy P. Craft Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: K990255

> Trade Name: Dimension® Drug Calibrator II Regulatory Class: II Product Code: DKB Dated: January 22, 1999 Received: January 27, 1999

Dear Ms. Craft:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Attac hment 1

Page 1 of 1

510(k) Number (if known)

Dimension @ Drug Calibrator II Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Dimension ®Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packages in Flex™ reagent cartridges:

Acetominophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)

Brian Comer

---

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number

Cathy P. Craft Regulatory Affairs and Compliance Manager

February 9, 1999

(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