# K012390: NO Step on Site Deug Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Drug Free Enterprises
- Decided: Dec 18, 2001 after 144 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Drug Free Enterprises NexStp test cup is a convenient specimen collection cup xnd strip holder, which contains five (5) individual drug test strips for simultancous detection of muiltiple drugs of abuse in human urine, The five test strips are individually encased within the wall of the device in separste chambers with no interconnections betwoen each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The nine individual test strips include THC, cocaine, opiate, methamphetamine, phencyclidine, amphetamine, barbiturates, benzodiazepines, and methadone. The cut-off cancentration for each of the available test strip is listed below: THC 11 -nor-A*>THC-9-COOH 50 ng/mt COC Benzoylecogine 300 og/ml OF' Morphine 2000 ng/ml MET Mcthamphetamines 1000 ng/ml PCP Phencyclidine 25 ng/ml AMP Amphetamines 1000 ng/ml BAR Secoberbital 300 ng/mi BZO Oxazcpam 300 ng/ml MTD Methadone 300 ng/ml Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine. The test is intended for professiopal and point of care use . This test device in not intended for over the counter sale to lay users. The NexStp test cup provides only preliminary analytical test results. A more specific alternate chemical method must be used in order to obtained a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Source page: https://510kreport.com/device/K012390
Methodology: https://510kreport.com/methodology