510(k) · Cleared
ClearedAcon Tri-Fect Drug Screen Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Sep 9, 2004 as substantially equivalent to K011673 (ACON Laboratories, Inc., 2001) and 10 other predicates after a 73-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 9, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 2 generations to K945610 (1995). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 1 generation backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- This deviceK041743 Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −1 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| 0 (this device) | K041743 | Acon Tri-Fect Drug Screen Test Device | ACON Laboratories, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 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? (11)
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 |
|---|---|---|---|
| * | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test DeviceSummary page 3…ompare their performance with clinical urine specimens. 510(k) Numbers for these predicate devices are: ACON AMP One Step Amphetamine Test Strip: K01 1673 ACON BAR One Step Barbiturates Test Strip: K012824 ACON BZO One Step Benzodiazepine Test Strip:… | 2001 |
| * | K012824 | Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test DeviceSummary page 3…or these predicate devices are: ACON AMP One Step Amphetamine Test Strip: K01 1673 ACON BAR One Step Barbiturates Test Strip: K012824 ACON BZO One Step Benzodiazepine Test Strip: K012300 ACON COC One Step Cocaine Test Strip:… | 2001 |
| * | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test…Summary page 3…est Strip: K01 1673 ACON BAR One Step Barbiturates Test Strip: K012824 ACON BZO One Step Benzodiazepine Test Strip: K012300 ACON COC One Step Cocaine Test Strip: K010841 ACON THC One Step Marijuana Test Strip:… | 2001 |
| * | K010841 | Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test DeviceSummary page 3…Test Strip: K012824 ACON BZO One Step Benzodiazepine Test Strip: K012300 ACON COC One Step Cocaine Test Strip: K010841 ACON THC One Step Marijuana Test Strip: K003557 ACON MDMA One Step Ecstasy Test Strip:… | 2001 |
| * | K003557 | Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device…Summary page 3…ne Test Strip: K012300 ACON COC One Step Cocaine Test Strip: K010841 ACON THC One Step Marijuana Test Strip: K003557 ACON MDMA One Step Ecstasy Test Strip: K022589 ACON MOP One Step Opiates Test Strip:… | 2001 |
| * | K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test DeviceSummary page 3…Strip: K010841 ACON THC One Step Marijuana Test Strip: K003557 ACON MDMA One Step Ecstasy Test Strip: K022589 ACON MOP One Step Opiates Test Strip: K013380 ACON OXY One Step Oxycodone Test Strip:… | 2002 |
| * | K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceSummary page 3…st Strip: K003557 ACON MDMA One Step Ecstasy Test Strip: K022589 ACON MOP One Step Opiates Test Strip: K013380 ACON OXY One Step Oxycodone Test Strip: K033047 ACON PCP One Step Phencyclidine Test Strip:… | 2001 |
| * | K033047 | Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test DeviceSummary page 3…est Strip: K022589 ACON MOP One Step Opiates Test Strip: K013380 ACON OXY One Step Oxycodone Test Strip: K033047 ACON PCP One Step Phencyclidine Test Strip: K011730 ACON PPX One Step Propoxyphene Test Strip:… | 2004 |
| * | K011730 | Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test DeviceSummary page 3…Strip: K013380 ACON OXY One Step Oxycodone Test Strip: K033047 ACON PCP One Step Phencyclidine Test Strip: K011730 ACON PPX One Step Propoxyphene Test Strip: K040445 ACON TCA One Step Tricyclic Antidepressants Test… | 2001 |
| * | K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceSummary page 3…st Strip: K033047 ACON PCP One Step Phencyclidine Test Strip: K011730 ACON PPX One Step Propoxyphene Test Strip: K040445 ACON TCA One Step Tricyclic Antidepressants Test Strip: K021526 Comparison to a Predicate Device: A comparison of the… | 2004 |
| * | K021526 | Acon Tca One Step Tricyclic Antidepressant Test Strip and DeviceSummary page 3…e Test Strip: K011730 ACON PPX One Step Propoxyphene Test Strip: K040445 ACON TCA One Step Tricyclic Antidepressants Test Strip: K021526 Comparison to a Predicate Device: A comparison of the features of the ACON ® TRI-fectT M Drug Screen Test Device versus the AC… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 17 ancestors has a recall.
- 3 other devices also cite its predicate K011673.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ACON TRI-fect Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300…
Read the full statement (147 words)
The ACON TRI-fect Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Cocaine 300 ng/mL, Marijuana 50 ng/mL, Methylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 ng/mL and Tricyclic Antidepressants 1,000 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
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.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041743: Acon Tri-Fect Drug Screen Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041743
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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