# K111322: Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: Sep 14, 2011 after 126 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- 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 K945610 (1995). 26 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 33 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 2.

## Most influential descendants
- K123080: 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 Chemntron Biotech, Inc.'s Chemtrue® 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 Benzodiazepines — BZO — Oxazepam — 300 ng/mL Barbiturates — BAR — Secobarbital/Pentobarbital — 300 ng/mL Ecstasy — MDMA/XTC — d,l-Methylenedioxymethamphetamine — 500 ng/mL Methadone — MTD — Methadone — 300 ng/mL Opiates — OPI/MOR — Morphine — 2000 ng/mL Oxycodone — OXY — Oxycodone — 100 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 in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter 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/K111322
Methodology: https://510kreport.com/methodology