510(k) · Cleared
Recalled · Class III · 2017Amedica Drug Screen Test Cup
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 Dec 19, 2008 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 19, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- NGL
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK082898 Amedica Drug Screen Test CupAmedica Biotech, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK122633 Toxcup Drug Screen CupBranan Medical Corp. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122633Toxcup Drug Screen CupBranan Medical Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082898 | Amedica Drug Screen Test Cup | Amedica Biotech, Inc. | 2008 | — |
| +1 | K122633 | Toxcup Drug Screen Cup | Branan Medical Corp. | 2013 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122633 | Toxcup Drug Screen Cup | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2017 | Class III | Z-0270-2019 | Nonconforming Material/Component | Product was released to market without the adulteration strip included in the product. |
| Jul 5, 2016 | Class III | Z-2311-2016 | Labeling mix-ups | Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122633 (Branan Medical Corp., 2013) has gone furthest, with 0 descendants of its own.
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. 2008, 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 Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cutoff Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OP1300 Pencyclidine Phencylidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR…
Read the full statement (273 words)
The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the
following drugs in human urine.
Drug Analyte Cutoff Device Code
Marijuana THC 50 ng/mL THC
Cocaine Benzoecgonine 300 ng/mL COC
Amphetamine Amphetamine 1000 ng/mL AMP
Methamphetamine Methamphetamine 1000 ng/mL MET
Opiates Morphine 2000 ng/mL OPI
Opiates300 Morphine 300 ng/ml OP1300
Pencyclidine Phencylidine 25 ng/mL PCP
Barbiturates Secobarbital 300 ng/mL BAR
Benzodiazepines Oxazepam 300 ng/mL BZD
Methadone Methadone 300 ng/mL MTD
Oxycodone Oxycodone 100 ng/mL OXY
MDMA MDMA 500 ng/mL MDMA
Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
This test is intended for over-the-counter (OTC) consumer use 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/K082898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082898: Amedica Drug Screen Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082898
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026