PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE

K130811 · Psychemedics Corp. · DKZ · May 2, 2013 · Clinical Toxicology

Device Facts

• Record ID: K130811
• Device Name: PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
• Applicant: Psychemedics Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The Psychemedics Microplate EIA for Amphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories. The Psychemedics Microplate EIA amphetamine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Double Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Device is an enzyme immunoassay (EIA) for detecting amphetamine in human hair. Process involves two stages: pre-analytical hair digestion to convert solid matrix to liquid, followed by microplate-based screening. Microplate wells are coated with methamphetamine-BSA conjugates; monoclonal mouse anti-amphetamine antibodies and HRP-conjugated secondary antibodies are used. Absorbance is measured at 450 nm via microplate reader. Used exclusively at Psychemedics laboratory. Results are preliminary; positive findings require confirmation via GC/MS or LC/MS/MS. Clinical judgment is required for interpretation. Benefits include identification of amphetamine use through hair analysis, which provides a longer detection window than other matrices.

Clinical Evidence

Bench testing only. Performance evaluated using 180 hair samples (head and body) compared against LC/MS/MS. Precision studies performed at cutoff and +/- 25%, 50%, 75% of cutoff. Cross-reactivity and interference studies conducted with 140 compounds. Cosmetic treatment studies (bleach, dye, relaxer, etc.) showed no significant impact on results. Contamination studies evaluated wash procedures (aqueous buffer and ethanol) to distinguish external contamination from ingestion.

Technological Characteristics

Enzyme immunoassay (EIA) system. Components: microplate wells coated with methamphetamine-BSA, monoclonal mouse anti-amphetamine, HRP-conjugated secondary antibody, TMB substrate, HCl stop solution, wash buffer. Measurement: microplate reader at 450 nm. Requires pre-analytical digestion. Standalone laboratory system.

Indications for Use

Indicated for preliminary qualitative detection of amphetamine in human head and body hair for identifying drug use. Intended for use with a 3 ng/10 mg hair cutoff. For professional use; requires confirmatory testing via GC/MS or LC/MS/MS.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k130811

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.