AMPHETAMINE/METHAMPHETAMINE

K012998 · Abbott Laboratories · LAF · Mar 13, 2002 · Clinical Toxicology

Device Facts

• Record ID: K012998
• Device Name: AMPHETAMINE/METHAMPHETAMINE
• Applicant: Abbott Laboratories
• Product Code: LAF · Clinical Toxicology
• Decision Date: Mar 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose. The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites. The Amphetamine/Methamphetamine 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 detection of amphetamine/methamphetamine in human urine; 1,000 ng/mL cutoff. Operates via homogeneous enzyme immunoassay; competition between specimen drug and G6PDH-labeled drug for antibody binding sites; enzyme activity inversely proportional to drug concentration. Used in clinical laboratories by laboratory personnel. Results provide preliminary screening; requires confirmation by GC/MS. Assists clinicians in diagnosing and managing drug use or overdose.

Clinical Evidence

Bench testing only. Method comparison study on AEROSET System showed 100% agreement with predicate (SYVA-30R Analyzer) and 81% agreement with GC/MS reference method. Precision studies (within-run and total) reported total %CVs ranging from 0.39% to 0.44% across five control levels. Limit of detection is 500 ng/mL.

Technological Characteristics

Homogeneous enzyme immunoassay; G6PDH enzyme label; competitive binding principle. Qualitative analysis; 1,000 ng/mL cutoff. Designed for use on automated clinical chemistry analyzers (e.g., AEROSET System).

Indications for Use

Indicated for qualitative analysis of amphetamine/methamphetamine in human urine in clinical laboratory settings to aid in diagnosis and treatment of drug use or overdose. Intended for professional use.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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 II Monoclonal Amphetamine/Methamphetamine assay (K920507)

Submission Summary (Full Text)

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# MAR 1 3 2002

# 510(k) Summary

K012998

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]

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

November 21, 2001 Amphetamine/Methamphetamine

Amphetamine/Methamphetamine

Classification Number/Class:

LAF/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: K012998.

## Test Description:

Amphetamine/Methamphetamine is an in vitro diagnostic assay for the qualitative analysis of amphetamine/methamphetamine in human urine. The assay is a homogeneous enzyme immunoassay with a 1,000 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. Enzyne activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

#### Substantial Equivalence:

The Amphetamine/Mothamphetamine assay is substantially equivalent to the Eimit® II Monoclonal Amphetarnine/Methamphetamine assay (K920507) on the SYVA®-30R Analyzer.

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## Both assays vield similar Performance Characteristics.

# Similarities:

- . Both assays are in vitro immunoassays.
- Both assays can be used for the qualitative analysis of amphetamine/methamine. .
- . 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:

- Amphetamine/Methamphetamine is a qualitative assay. Emit II is a qualitative and semiquantitative assay. .
### Intended Use:

The Amphetamine/Mcthamphetamine assay is used for the qualitative analysis of amphetamine in human urine with a cutoff of 1,000 ng/mL. For use in clinical laboratories.

The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will delect a variety of amphetamines and their metabolites.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The

Amphetamine/Methamphetamine assay method comparison yielded acceptable correlation with the Emir II Monoclonal Amphetamine assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Amphetamine assay method comparison yielded acceptable correlation with GC/MS. The concordiance table shows 81% agreement with GC/MS. The clinical specimens tested ranged from 826 to 1,994 ng/trL. Precision studies were conducted using the Amphetamine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.42%, Cutoff Calibrator is 0.40%. Verifier II is 0.39%. - 25% Connol of Cutoff Calibrator is 0.44%, and + 25% Control of Cuty/T Calibrator is 0.41%. The Amphetamine assay cutoff is 1,000 ng/mL. The limit of detection (sensitivity) of the Amphetamine/Methamphetamine assay is 500 ng/mL.

These data demonstrate that the performance of the Amphetamine assay is substantially equivalent to the performance of the Emit II Monoclonal Amphetamine assay on the SYVA-30R Analyzer.

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# Conclusion:

: 上一篇: 上一篇:

.

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

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MAR 1 3 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive 8-21 Irving, TX 75038

k012998 ... Re:

> Trade/Device Name: Amphetamine/Methamphetamine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ 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 Putman

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): K012998

Device Name: Amphetamine/Methamphetamine

Indications For Use:

The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose.

The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.

The Amphetamine/Methamphetamine 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 NEEDED)

Prescription Use_ (Per 21 CFR 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number, 1012958