METHADONE

K013001 · Abbott Laboratories · DJR · Mar 20, 2002 · Clinical Toxicology

Device Facts

• Record ID: K013001
• Device Name: METHADONE
• Applicant: Abbott Laboratories
• Product Code: DJR · Clinical Toxicology
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The Methadone assay is used for the qualitative analysis of methadone in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose. The Methadone assay is calibrated with methadone and is specific for methadone. The Methadone assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

In vitro diagnostic assay for qualitative methadone detection in human urine; utilizes homogeneous enzyme immunoassay (G6PDH competition) with 300 ng/mL cutoff; performed on AEROSET System in clinical laboratories by trained personnel; provides preliminary analytical results; requires confirmation via GC/MS; assists clinicians in diagnosing/treating methadone use or overdose.

Clinical Evidence

Bench testing only. Method comparison study on AEROSET System showed 100% agreement with Emit II Methadone assay and 99% agreement with GC/MS. Precision studies (within-run and total) reported total %CVs ranging from 0.63% to 0.74% across five control levels. Sensitivity (limit of detection) is 20 ng/mL.

Technological Characteristics

Homogeneous enzyme immunoassay (G6PDH). Qualitative analysis with 300 ng/mL cutoff. Calibrated for methadone specificity. Designed for use on automated clinical chemistry analyzers (e.g., AEROSET System).

Indications for Use

Indicated for qualitative analysis of methadone in human urine in clinical laboratory settings to assist 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

• Emit® TI Methadone assay (K920751)

Submission Summary (Full Text)

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MAR 2 0 2002

K013001

# 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Texas 75038

Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs [phone] Fax [phone]

November 21, 2001 Date of Preparation of this Summary: Methadone Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Methadone Classification Number/Class: DJR/Class II

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.

The assigned 510(k) number is: K013001.

### Test Description:

Methadone is an in vitro diagnostic assay for the qualitative analysis of methadone in human urine. The assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

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### Substantial Equivalence:

The Methadone assay is substantially equivalent to the Emit® TI Methadone assay (K920751) on the SYVA®-30R Analyzer.

Both assays yield similar Performance Characteristics.

#### Similarities:

:

- Both assays are in vitro immunoassays.
- . Both assays can be used for the qualitative analysis of Methadone.
- . Both assays yield similar results.
- . Both assays are based on the competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.

#### Differences:

- . There is a difference between the assay ranges (cutoff).
- . The Methadone assay is qualitative. The Emit II Methadone assay is qualitative and semiquantitative.

#### Intended Use:

The Methadone assay is used for the qualitative analysis of methadone in human urine with a cuto[f of 300 ng/mL. For use in clinical laboratories.

The Methadone assay is calibrated with methadone and is specific for methadone.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Methadone assay method comparison yielded acceptable correlation with the Emit II Methadone assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Methadone assay method comparison yielded acceptable correlation with GC/MS. The concordance table shows 99% agreement with GCMS. The clinical specimens tested ranged from 231.0 to 40,190.0 ng/mL. Precision studies were conducted using the Methadone assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.72%, Cutoff Calibrator is 0.72%,

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Verifier II is 0.63%, - 25% Control of Cutoff Calibrator is 0.74%, and + 25% Control of Cutoff Calibrator is 0.70%. The Methadone assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Methadone assay is 20 ng/mL. These data demonstrate that the performance of the Methadone assay is substantially equivalent to the performance of the Emit II Methadone assay on the SYVA-30R Analyzer.

## Conclusion:

The Methadone assay is substantially equivalent to the Emit II Methadone assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 0 2002

Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038

Re: k013001

> Trade/Device Name: Methadone Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Simpson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Sutman

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): K013001

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Methadone assay is used for the qualitative analysis of methadone in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose.

The Methadone assay is calibrated with methadone and is specific for methadone.

The Methadone assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|--------------------------------------------------------|-----------------------------|
| Prescription Use <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use ______ |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |
| (Division Sign-Off) | | |
| Division of Clinical Laboratory Devices | | |
| K013001 | | |