CEDIA DAU MULTI-DRUG CALIBRATORS

K980853 · Boehringer Mannheim Corp. · DKB · Apr 21, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980853
• Device Name: CEDIA DAU MULTI-DRUG CALIBRATORS
• Applicant: Boehringer Mannheim Corp.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The CEDIA ® DAU Multi-Drug Calibrators are used for the calibration of qualitative and semiquantitative CEDIA ® DAU assays in human urine on automated clinical chemistry analyzers.

Device Story

CEDIA DAU Multi-Drug Calibrators are in vitro diagnostic products used to calibrate automated clinical chemistry analyzers for drug-of-abuse testing. The calibrators consist of drug-free human urine spiked with specific drugs of abuse (d-methamphetamine, secobarbital, nitrazepam, morphine, benzoylecgonine, phencyclidine, and EDDP) and a preservative. They are provided as ready-to-use solutions. Laboratory technicians use these calibrators to establish a calibration curve on the analyzer, which is then used to determine the concentration of drugs in patient urine samples. This process ensures the accuracy and reliability of the qualitative and semiquantitative assay results, assisting healthcare providers in identifying the presence of drugs of abuse in clinical settings.

Clinical Evidence

Bench testing only. The device was validated by analyzing EDDP concentrations in the calibrators using GC/MS in two separate laboratories. Results showed mean concentrations (103.1 ng/mL for 100 ng/mL cutoff; 496.3 ng/mL for 500 ng/mL intermediate; 2033 ng/mL for 2000 ng/mL high) closely matching target values.

Technological Characteristics

Matrix: human urine; Preservative: sodium azide; Form factor: ready-to-use liquid; Analyte composition: multi-drug (d-methamphetamine, secobarbital, nitrazepam, morphine, benzoylecgonine, phencyclidine, EDDP); Calibration principle: enzyme immunoassay calibration for automated clinical chemistry analyzers; Storage: 2-8°C.

Indications for Use

Indicated for the calibration of qualitative and semiquantitative CEDIA DAU assays in human urine on automated clinical chemistry analyzers.

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

• Methadone Metabolite Urine Calibrators (Diagnostic Reagents, Inc.)

Submission Summary (Full Text)

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K980853

| APR 21 1998 | 510(k) Summary |
|-------------|----------------|
|-------------|----------------|

Introduction

According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.

| 1) Submitter name, address, contact | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94588-2722<br>[phone]<br>Fax: [phone] |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Betsy Soares-Maddox |
| | Date Prepared: March 2, 1998 |

| 2) Device name | Proprietary name: CEDIA ^® DAU Multi-Drug Calibrators |
|----------------|-------------------------------------------------------------------------------------------------------|
| | Common name: Drug of Abuse calibrators for use in the calibration of<br>CEDIA ^® DAU Assays |
| | Classification name: Calibrators, Drug Mixture |

| 3) Predicate device | We claim substantial equivalence to the Methadone Metabolite Urine<br>Calibrators manufactured by Diagnostic Reagents, Inc. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|

Continued on next page

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# 510(k) Summary, Continued

| 4) Device Description | The CEDIA ^® DAU Multi-Drug Calibrators are manufactured using drug free human urine, various drugs of abuse and a preservative. At this time, the drugs of abuse are d-methamphetamine, secobarbital, nitrazepam, morphine, benzoylecgonine, phencyclidine, and EDDP. The drug raw materials are obtained from a commercially available source and are spiked appropriately into the calibrator matrix to obtain the correct calibrator concentration levels. The calibrators are in-process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have had values confirmed using GC/MS by 3 laboratories. |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | The CEDIA ^® DAU Multi-Drug Calibrators are used for the calibration of qualitative and semiquantitative CEDIA ^® DAU assays in human urine on automated clinical chemistry analyzers. |

Continued on next page

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## 510(k) Summary, Continued

#### 6) Comparison to predicate device

The Boehringer Mannheim Modified CEDIA® DAU Multi-Drug Calibrators are substantially equivalent to other products in commercial distribution (8) DAU Multiintended for similar use. Most notably, the Modified CEDIA Drug Calibrators with the addition of EDDP are substantially equivalent to the Methadone Metabolite Urine Calibrators manufactured by Diagnostic Reagents Inc. (DRI).

| Feature | DRI EDDP Urine<br>Calibrators | Modified CEDIA®<br>DAU Multi-Drug<br>Calibrators |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Human Urine | Human Urine |
| Preservative | Sodium Azide | Sodium Azide |
| Storage conditions | 2-8 ° C | 2-8 ° C |
| Ease of use | Ready to use | Ready to use |
| EDDP concentration: | | |
| Cutoff calibrator | 300 ng/ml | 100 ng/ml |
| Intermediate Calibrator | 1000 ng/ml | 500 ng/ml |
| High Calibrator | 2000 ng/ml | 2000 ng/ml |
| Calibrator composition | Single analyte | Multiple analytes |
| Intended Use | For in vitro diagnostic<br>use for the calibration of<br>enzyme immunoassay<br>for detection of<br>methadone metabolites<br>in human urine. | For use as calibrators in<br>the CEDIA DAU<br>qualitative and<br>semiquantitative<br>determination of drugs<br>of abuse in human urine<br>on automated clinical<br>chemistry analyzers. |

Continued on next page

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### 510(k) Summary, Continued

#### Performance Characteristics:

6) Comparison to predicate device, (cont.)

The CEDIA® DAU Multi-Drug Calibrators were analyzed for EDDP by GC/MS in 2 separate laboratories. The results of the study were as follows:

| Calibrator | Target [EDDP]<br>ng/mL | Mean [EDDP]<br>ng/mL |
|-------------------|------------------------|----------------------|
| Primary Cutoffs | 100 | 103.1 |
| Secondary Cutoffs | 100 | 101.0 |
| Intermediate | 500 | 496.3 |
| High | 2000 | 2033 |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 21 1998

Betsy Soares-Maddox . Manager, Regulatory Affairs and Quality Assurance Boehringer Mannheim Coporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

Re : K980853 CEDIA® DAU Multi-Drug Calibrators Requlatory Class: II Product Code: DKB Dated: March 2, 1998 Received: March 5, 1998

Dear Ms. Soares-Maddox:

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 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 Requlations, 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 QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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.

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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 beqin 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 your 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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

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510(k) Number (if known): N/A

Device Name: CEDIA® DAU Multi-Drug Calibrators

Indications For Use:

The CEDIA® DAU Multi-Drug Calibrators are intended for the calibration of qualitative and semiquantitative CEDIA® DAU Assays on automated clinical chemistry andy zers.

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------|--------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | |
| | OR |
| | Over-The-Counter Use |

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical, Laboratory Devices
510(k) Number 980853