510(k) · Cleared
ClearedChemtrue Multi-Panel DOA DIP Card Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtron Biotech, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 1, 2014 as substantially equivalent to K102203 (Chemtron Biotech, Inc., 2011) and 3 other predicates after a 77-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 1, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K945610 (1995). 31 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 6 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 5 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 4 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 3 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 2 generations backK111322 Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardChemtron Biotech, Inc. · 2011
- 1 generation backK123080 Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsChemtron Biotech, Inc. · 2012
- This deviceK142580 Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK150602 CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK152643 EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA…Nantong Egens Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK151557 EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard…Nantong Egens Biotech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly1descendant
- K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd. · 2015 · cites it directly0descendants
- K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd. · 2015 · cites it directly0descendants
- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo 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 |
|---|---|---|---|---|---|
| −7 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −6 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −5 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −4 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −3 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −2 | 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 | — |
| 0 (this device) | K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | Chemtron Biotech, Inc. | 2014 | — |
| +1 | K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +1 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine… | Nantong Egens Biotech Co., Ltd. | 2015 | — |
| +1 | K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine… | Nantong Egens Biotech Co., Ltd. | 2015 | — |
| +2 | 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 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsSummary page 5…abuse dip card devices that combines drugs of abuse test strips from previously FDA cleared Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k102203, k111322, k121339, and k123080). These tests have been previously cleared for prescription use (k102203 and k111322) and ov… | 2011 |
| * | K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardSummary page 5…p card devices that combines drugs of abuse test strips from previously FDA cleared Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k102203, k111322, k121339, and k123080). These tests have been previously cleared for prescription use (k102203 and k111322) and over-the-co… | 2011 |
| * | K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsSummary page 5…vices that combines drugs of abuse test strips from previously FDA cleared Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k102203, k111322, k121339, and k123080). These tests have been previously cleared for prescription use (k102203 and k111322) and over-the-counter… | 2012 |
| * | K123080 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsSummary page 5…combines drugs of abuse test strips from previously FDA cleared Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k102203, k111322, k121339, and k123080). These tests have been previously cleared for prescription use (k102203 and k111322) and over-the-counter use (k1213… | 2012 |
What descends from it? (4)
3 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 19 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K150602 (Guangzhou Wondfo Biotech Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K102203.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Amphetamine AMP…
Read the full statement (455 words)
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL)
Amphetamine AMP d-Amphetamine 1000
Cocaine CcOoC Benzoylecgonine 300
Methamphetamine MAMP /MET d-Methamphetamine 1000
Morphine MOR Morphine 300
Phencyclidine PCP Phencyclidine 25
Marijuana THC 11-nor-A9-THC9-COOH 50
Benzodiazepines BZO Oxazepam 300
Barbiturates BAR Secobarbital/Pentobarbital 300
Ecstasy MDMA d,I-Methylenedioxymethamphetamine 500
Methadone MTD Methadone 300
Oxycodone 0).:4¢ Oxycodone 100
The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests 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.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL)
Amphetamine AMP d-Amphetamine 1000
Cocaine COC Benzoylecgonine 300
Methamphetamine =~ MAMP /MET d-Methamphetamine 1000
Opiates OPI Morphine 2000
Phencyclidine PCP Phencyclidine 25
Marijuana THC T-nor-A9-THC9-COOH 50
Benzodiazepines BZO Oxazepam 300
Barbiturates BAR Secobarbital/Pentobarbital 300
Ecstasy MDMA d,I-Methylenedioxymethamphetamine 500
Methadone MTD Methadone 300
Oxycodone OoxXY Oxycodone 100
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests 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.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142580: Chemtrue Multi-Panel DOA DIP Card Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142580
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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