# K143599: Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: Apr 17, 2015 after 120 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 K964355 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 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 8.
- K060896: Modification to Ontrak Testcup II and Onsite Cupkit, Varian, Inc. (2006) Summary page 8.

## Indications for use
The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine 300, 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 d-Methamphetamine 1000 Morphine MOR Morphine 300 Phencyclidine PCP Phencyclidine 25 Marijuana THC 11-nor-A9-THC9 COOH 50 Benzodiazepines BZO Oxazepam 300 Barbiturates BAR Secobarbital/Pentobarbital 300 Ecstasy MDMA d,lI-Methylenedioxymethamphetamine 500 Methadone MTD Methadone 300 Oxycodone OXY Oxycodone 100 The Chemtrue® Drug Screen Cup 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 cutoff concentration levels for these drugs in urine. The Chemtrue Drug Screen Cup Tests with OPI 2000 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 CcocC Benzoylecgonine 300 Methamphetamine MAMP d-Methamphetamine 1000 Opiates 2000 MOR Morphine 2000 Phencyclidine PCP Phencyclidine 25 Marijuana THC 11-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 OXY Oxycodone 100 The Chemtrue Drug Screen Cup Tests with OPI 2000 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 cutoff concentration levels for these drugs in urine,

Source page: https://510kreport.com/device/K143599
Methodology: https://510kreport.com/methodology