Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests

K142396 · Chemtron Biotech, Inc. · DJG · Oct 9, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142396
• Device Name: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
• Applicant: Chemtron Biotech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Oct 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Cassette Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine (BUP) and/or Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte: Buprenorphine, Abbreviation: BUP, Calibrator: Buprenorphine, Cutoff Concentration (ng/mL): 10; Analyte: Tricyclic Antidepressants, Abbreviation: TCA, Calibrator: Nortriptyline, Cutoff Concentration (ng/mL): 1000. The single and multi-panel tests are available in Dip Card, Cup and Cassette formats. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay 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. The tests are not intended to distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricyclic Antidepressants in urine.

Device Story

Rapid lateral flow immunoassays for qualitative detection of drugs of abuse in human urine; formats include dip card, cup, or cassette. Principle: competitive binding immunoassay using drug-protein conjugates and anti-drug antibody-colloidal gold conjugates. Input: human urine sample; capillary action moves sample across membrane. Output: visual color bands; presence of line in test region indicates negative result; absence indicates preliminary positive. Used in clinical or home settings; operated by healthcare professionals or lay-users. Results are preliminary; require confirmation via GC/MS or LC/MS. Clinical decision-making requires professional judgment. Benefits: rapid, preliminary screening for drugs of abuse.

Clinical Evidence

Performance evaluated via bench testing and lay-user studies. Method comparison study (n=174 clinical specimens) against GC/MS showed high agreement (96.3%-100%). Reproducibility study (n=30 per concentration level) conducted across 6 days with 3 operators. OTC lay-user study (n=300) confirmed ease of use and performance across various drug concentrations. Interference and cross-reactivity studies performed for >100 compounds.

Technological Characteristics

Lateral flow, competitive binding immunoassay. Materials: colloidal gold-labeled monoclonal/polyclonal anti-drug antibodies, drug-protein conjugates. Formats: dip card, cup, cassette. Standalone, single-use, in vitro diagnostic device. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Buprenorphine and/or Tricyclic Antidepressants in human urine. Intended for prescription and OTC use. Not intended to distinguish between prescription use or abuse of Buprenorphine or Tricyclic Antidepressants.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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) #: K142396

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 (SESE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this substantial equivalence determination.