# K123080: Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: Nov 29, 2012 after 59 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: 6 generations back to K945610 (1995). 27 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K111322: Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard, Chemtron Biotech, Inc. (2011)

## 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 Chemntron 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 designated cutoff concentrations of each drug 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 Chemntrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic and Over-The-Counter (OTC) use. The BAR,BZO and OXY assay will yield preliminary positive results when BAR, BZO, and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepine and Oxycodone in urine. The Chemntrue Single/Multi-Panel Drug Screen Cassette and Dip Card Tests shows the drug was or was not present at the cutoff level. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for tri-cyclic antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K123080
Methodology: https://510kreport.com/methodology