# K040464: Amedica Drug Screen THC/Coc, OP1300, PPX, Oxy, Bar/Bzo Test

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Biotech, Inc.
- Decided: May 17, 2004 after 84 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Amedica Drug Screen THC/COC, OP1300, PPX, OXY, BAR/BZO Test is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, propoxyphene, oxycodone, secobarbital and oxazepam in human urine at the following cut-off concentration THC 11-nor-A9-THC-9-COOH 50 ng/ml COC benzoylecgonine 300 ng/ml OPI morphine 300 ng/ml PPY propoxyphene 300 ng/ml OXY oxycodone 100 ng/ml BAR secobarbital 300 ng/ml BZO oxazepam 300 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for use in laboratories and workplaces by trained users. It is not intended for over the counter sale. For in vitro diagnostic use Minimum training for operators is defined as those individuals who have received instructions for drugs of abuse testing from a physician or medical review officer. Operators may be lay users with no prior experience in running laboratory tests, but who are expected to perform at least 5 tests per week. Training should cover a variety of topics such as the value of confirmation testing, how to obtain confirmation testing, false positive results, false negative results, and quality control procedures. We recommend that operators take a written and practical exam before performing any testing and that employers keep documentation of the training. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Source page: https://510kreport.com/device/K040464
Methodology: https://510kreport.com/methodology