# K082898: Amedica Drug Screen Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Biotech, Inc.
- Decided: Dec 19, 2008 after 80 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K122633: Toxcup Drug Screen Cup (2013), 0 descendants of its own

## Recalls of this device
- Sep 30, 2017 · Class III · Z-0270-2019: Product was released to market without the adulteration strip included in the product.
- Jul 5, 2016 · Class III · Z-2311-2016: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K082898
Methodology: https://510kreport.com/methodology