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

K123080 · Chemtron Biotech, Inc. · JXM · Nov 29, 2012 · Clinical Toxicology

Device Facts

• Record ID: K123080
• Device Name: CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
• Applicant: Chemtron Biotech, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Nov 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• 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. The BAR,BZO and OXY assay will yield preliminary positive results when BAR, BZO, and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepine and Oxycodone in urine. The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests shows the drug was or was not present at the cutoff level. This 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 for most drugs (HPLC is the preferred confirmatory method for tri-cyclic antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Device is a one-step lateral flow immunoassay for qualitative detection of drugs of abuse in human urine. Input is urine sample; principle of operation is competitive binding between drug in sample and drug-protein conjugate on membrane for limited antibody-colloidal gold sites. Output is visual color bands: two lines (control and test) indicate negative; one line (control only) indicates preliminary positive. Used in professional point-of-care or home settings by clinicians or lay-users. Results are visually interpreted by the user. Preliminary positive results require confirmatory testing via GC/MS or HPLC. Benefits include rapid, accessible screening for drug presence.

Clinical Evidence

Bench testing only. OTC accuracy study conducted with 200 lay-users (ages 21-79) across three sites. Compared device results to GC/MS reference method. Overall agreement >97.7%. Discordant results (9 total) occurred near cutoff levels (±25%). Package inserts evaluated for readability (Flesch-Kincaid 7th grade level) and user comprehension (95% rated instructions easy to follow).

Technological Characteristics

One-step lateral flow competitive immunoassay. Materials: plastic holder, membrane, drug-protein conjugate, antibody-colloidal gold conjugate. Dimensions: dip card or cassette format. Energy source: none (capillary action). Connectivity: none. Sterilization: not stated. Software: none.

Indications for Use

Indicated for qualitative detection of up to six drugs (BZO, BAR, MDMA, MTD, OPI, OXY) in human urine. Intended for use by healthcare professionals and OTC lay-users. Provides preliminary analytical results; requires confirmation by GC/MS or HPLC.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine 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, K123080

This 510(k) was reviewed under OIR’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.