# K102203: Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: Jan 20, 2011 after 169 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: 1 generation back to K020771 (2002). 1 ancestor in all.
6 later devices descend from it; 2 cite 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)
- K020771: Acon One Step Drug Screen Test Card, ACON Laboratories, Inc. (2002) Summary page 2.

## Most influential descendants
- K121339: Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (2012), 5 descendants of its own
- 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

## Indications for use
The Chemitron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid chromatographic 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 direct calibrator 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 — 11I-oA 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 are intended for qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic use and prescription use ONLY. It is not intended for point-of-care settings or over the counter use. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical 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/K102203
Methodology: https://510kreport.com/methodology