510(k) · Cleared
ClearedAmedicheck Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma,Bar, BZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Biotech, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Aug 19, 2008 after a 141-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 19, 2008
- Review
- 141 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. 2008, this device’s year, is highlighted.
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?
The AmediCheck Drug Screen Test THC/COC/OPI/AMP/MET/PCP/BAR/BZO/MDMA/OXY/MTD/PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants in human urine at the following cutoff concentration: THC I l-nor-A9 -Tetrahydrocannabinol-9-carboxylic 50 ng,ml COC Benzoylecgonine 300…
Read the full statement (182 words)
The AmediCheck Drug Screen Test THC/COC/OPI/AMP/MET/PCP/BAR/BZO/MDMA/OXY/MTD/PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants in human urine at the following cutoff concentration:
THC I l-nor-A9 -Tetrahydrocannabinol-9-carboxylic 50 ng,ml
COC Benzoylecgonine 300 ng,ml
ON Morphine 2000 ng,ml
OPI Morphine 300 ng,ml
AMP Amphetamine 1000 ng, ml
MET Methamphetamine 1000 ng,ml
PCP Phencyclidine 25 ng,ml
MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml
BAR Secobarbital 300 ng/ml
BZO Oxazeparn 300 ng/ml
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
PPX Propoxyphene 300 ng/ml
OXY Oxycodone 300 ng/ml
This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.
This assay provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the pref eiTed confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080872: Amedicheck Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma,Bar, BZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080872
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026