510(k) · Cleared
ClearedChemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtron Biotech, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Nov 29, 2012 as substantially equivalent to K111322 (Chemtron Biotech, Inc., 2011) after a 59-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 29, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945610 (1995). 27 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 4 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 3 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 2 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 1 generation backK111322 Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardChemtron Biotech, Inc. · 2011
- This deviceK123080 Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsChemtron Biotech, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK142580 Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK150602 CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK152643 EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA…Nantong Egens Biotech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK151557 EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard…Nantong Egens Biotech Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 5 of 5 · See all- K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014 · cites it directly4descendants
- K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2015 · 2 generations on1descendant
- K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd. · 2015 · 2 generations on0descendants
- K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd. · 2015 · 2 generations on0descendants
- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −5 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −4 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −3 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −2 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −1 | K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard | Chemtron Biotech, Inc. | 2011 | — |
| 0 (this device) | K123080 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests | Chemtron Biotech, Inc. | 2012 | — |
| +1 | K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | Chemtron Biotech, Inc. | 2014 | — |
| +2 | K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +2 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine… | Nantong Egens Biotech Co., Ltd. | 2015 | — |
| +2 | K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine… | Nantong Egens Biotech Co., Ltd. | 2015 | — |
| +3 | K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JXM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | 2014 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K142580 (Chemtron Biotech, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K111322.
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (269 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123080: Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123080
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026