# K121065: Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device  and Dipcard Drugs of Abuse Screen Device

- Pathway: 510(k) (Traditional)
- Applicant: Polymed Therapeutics, Inc.
- Decided: May 24, 2013 after 413 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945610 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011673: Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device, ACON Laboratories, Inc. (2001)
- K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device, ACON Laboratories, Inc. (2002) Summary page 2.
- K011353: Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine), ACON Laboratories, Inc. (2001) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K121065
Methodology: https://510kreport.com/methodology