# K142580: Chemtrue Multi-Panel DOA DIP Card Tests

- Pathway: 510(k) (Special)
- Applicant: Chemtron Biotech, Inc.
- Decided: Dec 1, 2014 after 77 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945610 (1995). 31 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102203: Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests, Chemtron Biotech, Inc. (2011) Summary page 5.
- K111322: Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard, Chemtron Biotech, Inc. (2011) Summary page 5.
- K121339: Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests, Chemtron Biotech, Inc. (2012) Summary page 5.
- K123080: Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests, Chemtron Biotech, Inc. (2012) Summary page 5.

## Most influential descendants
- K150602: CR3 Keyless Split Sample Cup Morphine - Methamphetamine (2015), 1 descendant of its own
- K152643: EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana (2015), 0 descendants of its own
- K151557: EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine (2015), 0 descendants of its own
- K151478: Wondfo CR3 Keyless Split Sample Cup (2015), 0 descendants of its own

## Indications for use
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone and Oxycodone 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) Amphetamine AMP d-Amphetamine 1000 Cocaine CcOoC Benzoylecgonine 300 Methamphetamine MAMP /MET 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,I-Methylenedioxymethamphetamine 500 Methadone MTD Methadone 300 Oxycodone 0).:4¢ Oxycodone 100 The Chemtrue® Multi-Panel DOA 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 and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine. The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone 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) 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 T-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 OoxXY Oxycodone 100 The Chemtrue® Multi-Panel DOA 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 and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Source page: https://510kreport.com/device/K142580
Methodology: https://510kreport.com/methodology