510(k) · Cleared
ClearedChemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard
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 Sep 14, 2011 as substantially equivalent to K061718 (Innovacon, Inc., 2006) after a 126-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.
- Decided
- Sep 14, 2011
- Review
- 126 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945610 (1995). 26 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 4 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 3 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 2 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 1 generation backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- This deviceK111322 Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardChemtron Biotech, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK123080 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123080Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsChemtron Biotech, Inc. · 2012 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −4 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −3 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −2 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −1 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| 0 (this device) | K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard | Chemtron Biotech, Inc. | 2011 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061718 | Innovacon Spectrum II Test CardSummary page 2…ACON (Alere) One Step Drug Screen Test Card K(061718 Barbiturates ACON (Alere) One Step Drug Screen Test Card K061718 Ecstasy (MDMA) ACON (Alere) One Step Drug Screen Test Card K(061718 Methadone… | 2006 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K123080 (Chemtron Biotech, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K061718.
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 —…
Read the full statement (212 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111322: Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111322
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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