510(k) · Cleared
ClearedAmedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Biotech, Inc. · NGL Test, Opiates, Over The Counter
Cleared on Apr 14, 2010 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 14, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- NGL
- 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 NGL? 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 NGL device
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- #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 NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amedica Drug Screen Test THC/COC/OPL/AMP/MET/PCP/MDMA/BARIBZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine THC 1 1-nor-A⁹-Tetrahydrocannabinol-9-carboxylic 50 ng/mI COC Benzoyiecgonine 300 ng/mI OPI Morphine 300 ng/ml OPI Morphine 2000 ng/ml AMP Amphetamine 1000 ng/ml MET Methamphetamine 1000 ng/ml PCP Phencyclidine 25 ng/ml MDMA 3,4 methylenedioxymethamphetamine 500 nglml BAR Secobarbital…
Read the full statement (257 words)
The Amedica Drug Screen Test
THC/COC/OPL/AMP/MET/PCP/MDMA/BARIBZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine
THC 1 1-nor-A⁹-Tetrahydrocannabinol-9-carboxylic 50 ng/mI
COC Benzoyiecgonine 300 ng/mI
OPI Morphine 300 ng/ml
OPI Morphine 2000 ng/ml
AMP Amphetamine 1000 ng/ml
MET Methamphetamine 1000 ng/ml
PCP Phencyclidine 25 ng/ml
MDMA 3,4 methylenedioxymethamphetamine 500 nglml
BAR Secobarbital 300 ng/ml
BZO Oxazepam 300 ng/mI
MTD Methadone 300 ng/ml
TCA Nortriptyline 1000 ng/ml
OXY Oxycodone 300 ng/ml
This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will yield preliminary positive results when prescription drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is 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 obtained.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100108: Amedica Drug Test THC, Coc, Opi, Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100108
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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