CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS

K121339 · Chemtron Biotech, Inc. · DKZ · May 17, 2012 · Clinical Toxicology

Device Facts

• Record ID: K121339
• Device Name: CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
• Applicant: Chemtron Biotech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The Chemtrue® test device is intended for the qualitative detection of drugs of abuse, for Over-the-Counter (OTC) and in vitro diagnostic use. The 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 Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle. Device consists of test strips in plastic holder (dip card or cassette). Urine sample migrates via capillary action; drug-protein conjugates on membrane compete with any drug present in sample for limited antibody-colloidal gold conjugate binding sites. Absence of color band at test region indicates preliminary positive result; presence of color band at control region confirms test validity. Used in point-of-care or home settings by healthcare professionals or lay-users. Results read visually after 5 minutes. Provides preliminary screening; requires confirmatory testing via GC/MS or LC/MS. Assists in identifying potential drug use; clinical judgment required for interpretation.

Clinical Evidence

Clinical performance evaluated via OTC accuracy study with 200 lay-users across three sites. Samples were blind-labeled spiked urine compared against GC/MS reference method. Results showed 98.9% total correlation with GC/MS. Individual analyte agreement ranged from 98.9% to 100%.

Technological Characteristics

One-step lateral flow competitive immunoassay. Components: plastic holder, membrane with immobilized drug-protein conjugates, antibody-colloidal gold conjugate pads. Visual readout. Storage: 2-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of up to 6 drugs (Amphetamine, Cocaine, Marijuana/THC, Methamphetamine, Opiates/Morphine, Phencyclidine) in human urine. Intended for OTC and professional in vitro diagnostic use. Provides preliminary results requiring GC/MS or LC/MS confirmation.

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)

{0}

# Decision Summary

Statement for the Record, k121339

This 510(k) was reviewed under OIVD’s Pilot Triage 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.