CEDIA DAU EDDP ASSAY

K980746 · Boehringer Mannheim Corp. · DJR · May 26, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980746
• Device Name: CEDIA DAU EDDP ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: DJR · Clinical Toxicology
• Decision Date: May 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The CEDIA® DAU EDDP Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and semiquantitative determination of EDDP in human urine on automated clinical chemistry analyzers. Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose.

Device Story

Assay utilizes homogeneous enzyme immunoassay technology to detect EDDP in human urine samples. Operates on automated clinical chemistry analyzers in clinical laboratory settings; performed by laboratory technicians. Input: human urine sample; Transformation: monoclonal antibody-based enzyme immunoassay reaction; Output: qualitative or semi-quantitative EDDP concentration levels. Healthcare providers use results to assess methadone use or overdose status, facilitating clinical decision-making regarding patient treatment. Benefits include rapid, automated screening for methadone metabolites.

Clinical Evidence

Bench testing only. Performance characteristics compared to predicate (DRI EIA) and HPLC. Accuracy: 81.6% relative sensitivity and 95.1% relative specificity vs. DRI EIA; 95.4% relative sensitivity and 98.2% relative specificity vs. HPLC. Precision (intra-assay) reported for various concentration levels with %CV ranging from 1.0% to 1.3%. Specificity testing included cross-reactivity analysis for EMDP and Methadone.

Technological Characteristics

Homogeneous enzyme immunoassay; utilizes monoclonal antibodies. Designed for use on automated clinical chemistry analyzers. Qualitative and semi-quantitative measurement capability. No specific materials of construction or software algorithm architecture details provided beyond standard immunoassay principles.

Indications for Use

Indicated for the qualitative and semi-quantitative determination of EDDP (methadone metabolite) in human urine to aid in the diagnosis and treatment of methadone use or overdose.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Methadone Metabolite Enzyme Immunoassay (K931780)

Submission Summary (Full Text)

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BOEHRINGER MANN

.........

1/14/98 14:23 FAX [phone] BOEHRINGER MANN

MAY 26 1998 K980746

**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.

| <b>1) Submitter name, address, contact</b> | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94588-2722<br>[phone]<br>Fax: [phone] |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Betsy Soares-Maddox<br>Date Prepared: February 24, 1998 |
| <b>2) Device name</b> | Proprietary name: CEDIA ^® DAU EDDP Assay<br>Common name: Homogeneous enzyme immunoassay for the determination of EDDP levels in urine.<br>Classification name: Methadone test system |
| <b>3) Predicate device</b> | We claim substantial equivalence to the Methadone Metabolite Enzyme Immunoassay (K931780) manufactured by Diagnostic Reagents, Inc. |

*Continued on next page*

Boehringer Mannheim Corporation CEDIA DAU EDDP Assay page 25

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# 510(k) Summary, Continued

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### 510(k) Summary, Continued

The Boehringer Mannheim CEDIA® DAU EDDP Assay is substantially 6) Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Methadone Metabolite Enzyme Immunoassay (K931780) manufactured by Diagnostic Reagents, Inc (DRI). The following table compares the CEDIA® DAU EDDP Assay with the

predicate device, Methadone Metabolite Enzyme Immunoassay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.

#### Similarities:

- Both assays are for the qualitative and semi-quantitative determination of . EDDP levels in human urine.
- Both assays utilize a monoclonal antibody. .
- Both are enzyme immunoassays. .
- Both assays may be used on the same instrumentation. .
- Both assays have a similar assay range. .

#### Differences:

- The two assays have different cutoff concentrations. .
Continued on next page

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## 510(k) Summary, Continued

Performance Characteristics: 6) Comparison to predicate device, (cont.)

| Feature | DRI Methadone Metabolite EIA | | | CEDIA® DAU EDDP | | |
|----------------------------------------------------|--------------------------------|--------------------------------------------------------|-------------------------|---------------------------------|------------------------|----------------------------|
| Precision | Intra assay | | | Intra assay | | |
| Concentration Level<br>N<br>%CV | Negative<br>10<br>0.1 | 300 ng/ml<br>10<br>0.1 | 2000 ng/ml<br>10<br>0.3 | 75 ng/ml<br>21<br>1.1 | 100 ng/ml<br>21<br>1.0 | 125 ng/ml<br>21<br>1.3 |
| Qualitative<br>Sensitivity | 75 ng/mL (2 S.D.) | | | 6.3 ng/mL (3 S.D.) | | |
| Rate Separation | | | | | | |
| Negative Calibrator<br>or Low Control to<br>Cutoff | 18 mAU/min<br>(0-300 ng/mL) | | | 19.4 mAU/min<br>(75-100 ng/mL) | | |
| Cutoff to High<br>Calibrator or Control | 81 mAU/min<br>(300-2000 ng/mL) | | | 13.2 mAU/min<br>(100-125 ng/mL) | | |
| Accuracy | 300 ng/mL Cutoff: | | | 100 ng/mL Cutoff: | | |
| Relative Sensitivity<br>Relative Specificity | Not reported<br>Not reported | | | vs. DRI EIA<br>81.6%<br>95.1% | | vs. HPLC<br>95.4%<br>98.2% |
| Specificity | | Concentration which gives a<br>positive result (ng/mL) | | Conc.<br>(ng/mL) | [EDDP]<br>Obs. ng/ml | % Cross-<br>reactivity |
| EDDP | | 300 | | 100 | 100 | 100 |
| EMDP | | 400 | | 200000 | 7.4 | 0.004 |
| Methadone | | 5000 | | 600000 | 98.6 | 0.016 |

Boehringer Mannheim Corporation CEDIA DAU EDDP Assay page 28

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a bird or eagle, with three overlapping lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

MAY 26 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Julie A. Smith Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

K980746 Re: CEDIA® EDDP® Assay Requlatory Class: II DJR Product Code: Dated: April 24, 1998 Received: April 28, 1998

Dear Ms. Smith:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨਾ 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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 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 for 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 Gutman

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 EDDP Assay

Indications For Use:

The CEDIA® DAU EDDP Assay is a homogeneous enzy me immunoassay for the in vitro qualitative and semiquantitative determination of EDDP in human urine on automated clinical chemistry analy zers. Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose.

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------|--------------------------------------------------------|--------------------------|
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

510(k) Number _

(Division Sign-Off)
Division of Clinical Laboratory Devices