# K142396: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests - Pathway: 510(k) (Traditional) - Applicant: Chemtron Biotech, Inc. - Decided: Oct 9, 2014 after 43 days - Product code: DJG (Enzyme Immunoassay, Opiates) - Device class: 2 - Regulation: 21 CFR 862.3650 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K945610 (1995). 26 ancestors in all. 10 later devices descend from it; 8 cite it directly. 0 of 37 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K061718: Innovacon Spectrum II Test Card, Innovacon, Inc. (2006) Summary page 6. ## Most influential descendants - K182654: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (2018), 2 descendants of its own - K201120: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (2020), 1 descendant of its own - K202453: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (2021), 0 descendants of its own - K181968: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (2018), 0 descendants of its own - K181790: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (2018), 0 descendants of its own ## Indications for use Chemtrue® BUP / TCA Single/Multi-Panel Drug Screen Dip Card / Cup / Cassette Tests: The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card /Cup/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 Abbreviation Calibrator Cutoff Concentration (ng/mlL.) Buprenorphine BUP Buprenorphine 10 Tricyclic Antidepressants TCA Nortriptyline 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. Chemtrue® Multi-Panel Drug Screen Dip Card Tests: The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Buprenorphine BUP Buprenorphine 10 Tricyclic Antidepressants TCA Nortriptyline 1000 Amphetamine AMP d-Amphetamine 1000 Cocaine 8.6 & Benzoylecgonine 300 Methamphetamine MAMP /MET d-Methamphetamine 1000 Morphine MOR Morphine 300 Phencyclidine PCP Phencyclidine 25 Marijuana THC 1 1-nor-A9-THC9-COOH 50 Benzodiazepines BZO Oxazepam 300 Barbiturates BAR Secobarbital/Pentobarbital 300 Ecstasy MDMA d,I-Methylenedioxymethamphetamine 500 Methadone MTD Methadone 300 Oxycodone 0).04 Oxycodone 100 The Chemtrue® Multi-Panel Drug Screen Dip Card Tests panel can consist of any combination of the above listed drug analytes. 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 differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine. Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests: The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Buprenorphine BUP Buprenorphine 10 Tricyclic Antidepressants TCA Nortriptyline 1000 Amphetamine AMP d-Amphetamine 1000 Cocaine coC Benzoylecgonine 300 Methamphetamine MAMP /MET d-Methamphetamine 1000 Opiates OPI Morphine 2000 Phencyclidine PCP Phencyclidine 25 Marijuana THC I1-nor-A9-THC9-COOH 50 Benzodiazepines BZO Oxazepam 300 Barbiturates BAR Secobarbital/Pentobarbital 300 Ecstasy MDMA d,l-Methylenedioxymethamphetamine 500 Methadone MTD Methadone 300 Oxycodone OoXY Oxycodone 100 The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests can consist of any combination of the above listed drug analytes. 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 differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine. Source page: https://510kreport.com/device/K142396 Methodology: https://510kreport.com/methodology