# K121339: Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: May 17, 2012 after 14 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: 2 generations back to K020771 (2002). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 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 6.

## Most influential descendants
- K142580: Chemtrue Multi-Panel DOA DIP Card Tests (2014), 4 descendants of its own
- 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 Chemtron Biotech, Inc.'s Chemntrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows: Analyte — Abbreviation — Calibrator — Cutoff Concentration Amphetamine — AMP — d-Amphetamine — 1000 ng/mL Cocaine — COC — Benzoylecgonine — 300 ng/mL Marijuana — THC — 11-nor-A 9-THC9-COOH — 50 ng/mL Methamphetamine — MET — d-Methamphetamine — 1000 ng/mL Opiates — OPI/MOR — Morphine — 300 ng/mL Phencyclidine — PCP — Phencyclidine — 25 ng/mL The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professional, in vitro diagnostic and Over-the-Counter (OTC) use. These assays 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.

Source page: https://510kreport.com/device/K121339
Methodology: https://510kreport.com/methodology