510(k) · Cleared
ClearedPolymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymed Therapeutics, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 24, 2013 as substantially equivalent to K011673 (ACON Laboratories, Inc., 2001) and 6 other predicates after a 413-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 24, 2013
- Review
- 413 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K945610 (1995). 10 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 deviceK121065 Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device…Polymed Therapeutics, Inc. · 2013
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) | K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard… | Polymed Therapeutics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 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? (7)
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 Device | 2001 |
| * | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test…Summary page 2…ce with the GC/MS and/or LC/MS confirmed clinical urine specimfens. 510(k) numbers for predicate devices are: Amphetamine kOl 11673 Benrodiazepine k012300 Cocaine k010841 MDMA k022589 Morphine 2000 k011353 PCP k011730 T… | 2001 |
| * | K010841 | Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test DeviceSummary page 2…onfirmed clinical urine specimfens. 510(k) numbers for predicate devices are: Amphetamine kOl 11673 Benrodiazepine k012300 Cocaine k010841 MDMA k022589 Morphine 2000 k011353 PCP k011730 TH-C k003557… | 2001 |
| * | K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test DeviceSummary page 2…ns. 510(k) numbers for predicate devices are: Amphetamine kOl 11673 Benrodiazepine k012300 Cocaine k010841 MDMA k022589 Morphine 2000 k011353 PCP k011730 TH-C k003557… | 2002 |
| * | K011353 | Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test DeviceSummary page 2…e devices are: Amphetamine kOl 11673 Benrodiazepine k012300 Cocaine k010841 MDMA k022589 Morphine 2000 k011353 PCP k011730 TH-C k003557… | 2001 |
| * | K011730 | Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test DeviceSummary page 2…kOl 11673 Benrodiazepine k012300 Cocaine k010841 MDMA k022589 Morphine 2000 k011353 PCP k011730 TH-C k003557… | 2001 |
| * | K003557 | Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device…Summary page 2…k012300 Cocaine k010841 MDMA k022589 Morphine 2000 k011353 PCP k011730 TH-C k003557 2… | 2001 |
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 18 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 10 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. 2013, 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?
Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows: Analyte Abbreviation Direct Calibrator Cutoff (ng/mL) Amphetamine AMP…
Read the full statement (166 words)
Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows:
Analyte Abbreviation Direct Calibrator Cutoff (ng/mL)
Amphetamine AMP Amphetamine 1000
Benzodiazepines BZO Oxazepam 300
Cocaine COC Benzoylecgonine 300
Marijuana THC I I -nor-A9-THC9-COOH 50
Morphine MOR Morphine 2000
Phencyclidine PCP Phencyclidine 25
Ecstasy MDMA .3,4-Methylenediioxy-MET 500
For prescription use in central laboratories only. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmred analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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 indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121065: Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121065
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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