# K142408: FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

- Pathway: 510(k) (Traditional)
- Applicant: Polymed Therapeutics, Inc.
- Decided: Sep 25, 2014 after 28 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K050186 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052115: First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy, First Check Diagnostics, LLC (2005) Summary page 4.

## Indications for use
FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use. FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Source page: https://510kreport.com/device/K142408
Methodology: https://510kreport.com/methodology