# K232736: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test - Pathway: 510(k) (Traditional) - Applicant: Chemtron Biotech, Inc. - Decided: Dec 20, 2023 after 104 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: 6 generations back to K964355 (1996). 45 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 47 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K153192: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests, Chemtron Biotech, Inc. (2016) Summary page 9. ## Most influential descendants - K252684: Labcorp Fentanyl Urine Visual Test (2026), 0 descendants of its own ## Indications for use The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and 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 Conc. (ng/mL) Amphetamine AMP d-Amphetamine 300 Amphetamine AMP d-Amphetamine 500 Amphetamine AMP d-Amphetamine 1,000 Barbiturates BAR Secobarbital/Pentobarbital 200 Barbiturates BAR Secobarbital/Pentobarbital 300 Benzodiazepines BZO Oxazepam 200 Benzodiazepines BZO Oxazepam 300 Buprenorphine BUP Buprenorphine 10 Cocaine COC Benzoylecgonine 150 Cocaine COC Benzoylecgonine 300 Ecstasy MDMA d,I-Methylenedioxy methamphetamine 500 Norfentanyl FYL Norfentanyl 5 Methamphetamine MET d-Methamphetamine 300 Methamphetamine MET d-Methamphetamine 500 Methamphetamine MET d-Methamphetamine 1,000 Marijuana THC 11-nor-A9-THC-9-COOH 50 Methadone MTD Methadone 300 Morphine MOR Morphine 300 Opiates OPI Morphine 2,000 Oxycodone 10):4¢ Oxycodone 100 Phencyclidine PCP Phencyclidine 25 Propoxyphene PPX Propoxyphene 300 Tricyclic Antidepressants TCA Nortriptyline 1,000 Tramadol TML Tramadol 100 The multi test panels can consist of any drug analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device. 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, Propoxyphene and Tricyclic Antidepressants. The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and 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 Conc. (ng/mL) Amphetamine AMP d-Amphetamine 300 Amphetamine AMP d-Amphetamine 500 Amphetamine AMP d-Amphetamine 1,000 Barbiturates BAR Secobarbital/Pentobarbital 200 Barbiturates BAR Secobarbital/Pentobarbital 300 Benzodiazepines BZO Oxazepam 200 Benzodiazepines BZO Oxazepam 300 Buprenorphine BUP Buprenorphine 10 Cocaine COC Benzoylecgonine 150 Cocaine COC Benzoylecgonine 300 Ecstasy MDMA d,I-Methylenedioxy methamphetamine 500 Norfentanyl FYL Norfentanyl 5 Methamphetamine MET d-Methamphetamine 300 Methamphetamine MET d-Methamphetamine 500 Methamphetamine MET d-Methamphetamine 1,000 Marijuana THC 11-nor-A9-THC-9-COOH 50 Methadone MTD Methadone 300 Morphine MOR Morphine 300 Opiates OPI Morphine 2,000 Oxycodone 10):4¢ Oxycodone 100 Phencyclidine PCP Phencyclidine 25 Propoxyphene PPX Propoxyphene 300 Tricyclic Antidepressants TCA Nortriptyline 1,000 Tramadol TML Tramadol 100 The multi test panels can consist of any drug analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device. 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, Propoxyphene and Tricyclic Antidepressants. The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 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) Norfentanyl FYL Norfentanyl 5 Tramadol TML Tramadol 100 The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels. 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 test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only. The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 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) Norfentanyl FYL Norfentanyl 5 Tramadol TML Tramadol 100 The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels. 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 test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only. Source page: https://510kreport.com/device/K232736 Methodology: https://510kreport.com/methodology