OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

K101973 · Omega Laboratories, Inc. · LAF · Aug 16, 2011 · Clinical Toxicology

Device Facts

• Record ID: K101973
• Device Name: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
• Applicant: Omega Laboratories, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Aug 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Indications for Use

The Omega Laboratories Hair Drug Screening Assay for Methamphetamine and MDMA is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (AMP) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. To confirm a screen positive result a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.

Device Story

Laboratory-based screening assay for Methamphetamine and MDMA in human hair; utilizes ELISA reagents and micro-plate reader; qualitative detection at 500 pg/mg cutoff; intended for professional laboratory use; results require confirmation via GC/MS; aids in identifying drug use; clinical decision-making relies on professional judgment of presumptive positive results.

Clinical Evidence

Bench testing only. Performance studies evaluated precision, agreement, cosmetic treatment effects, cross-reactivity, and environmental contamination. Results demonstrated substantial agreement with the predicate device.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) reagents; micro-plate reader; qualitative detection; cutoff 500 pg/mg; utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA kit.

Indications for Use

Indicated for qualitative detection of Methamphetamine and MDMA in human head hair at or above 500 pg/mg to identify drug 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

• Quest Diagnostics HairCheck-DT (Amphetamines) (k051161)

Submission Summary (Full Text)

{0}

Omega Laboratories, Inc.
510(k) Summary
Omega Hair Drug Screening Assay for Methamphetamine and MDMA

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

510(k) Number: K1019731
Date of Summary: January 11, 2012 (corrected)
Applicant: William R. Corl
Vice President of Operations
Omega Laboratories, Inc.
400 North Cleveland
Mogadore, OH 44260
Tel: [phone]
Fax: [phone]

Correspondent:
Name: Robert J Bard, JD
Address: Omega Laboratories
400 North Cleveland, Mogadore, OH 44260
Phone Number: 248-573-5040
E-mail: [e-mail]

Product Name:
Trade Name: the Omega Laboratories Hair Drug Screening Assay
Methamphetamine_3, 4-methylenedioxymethamphetamine (Meth_MDMA)
Common Name: Hair Drug Screening Assay Methamphetamine
Regulation Number: CFR 862.3610 (ProCode LAF)
Classification Name: Enzyme immunoassay, Methamphetamine
Methamphetamine test System
Classification Panel: 91 (Toxicology)
Predicate Device: Quest Diagnostics HairCheck-DT (Amphetamines) k051161;
Product Description: The Omega Laboratories Hair Drug Screening Assays for Methamphetamine_3,4-methylenedioxymethamphetamine (Meth_MDMA) is a test system using ELISA reagents and micro-plate reader for the qualitative detection of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in hair samples at or above 500 pg/mg.

Indication for Use: The Omega Laboratories Hair Drug Screening Assay for Methamphetamine and MDMA is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (AMP) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or

Page 1 of 2

{1}

Omega Laboratories, Inc.
510(k) Summary
Omega Hair Drug Screening Assay for Methamphetamine and MDMA

above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. To confirm a screen positive result a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.

**Comparison:** When used to qualitatively detect methamphetamine and/or MDMA in head hair specimens collected with the Omega Specimen Collection Device, the Omega assays yield results in substantial agreement with the predicate device.

**Comparison Performance Data:** Performance characteristic studies were conducted for
- Precision
- Agreement
- Cosmetic Treatment
- Cross-reactivity
- Environmental Contamination

All performance studies demonstrated that the Omega assay is in substantial agreement with the Quest Diagnostic product.

Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices.

**Conclusion:** The Omega Laboratories Hair Drug Screening Assay for Methamphetamine and MDMA is substantially equivalent to the Quest Diagnostics HairCheck-DT (Amphetamines) k051161.

Page 2 of 2