510(k) · Cleared
ClearedNO Step on Site Deug Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drug Free Enterprises · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Dec 18, 2001 after a 144-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 18, 2001
- Review
- 144 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | — | 0 | 0 |
| 2008 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (231 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012390 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012390: NO Step on Site Deug Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012390
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026