510(k) · Cleared
ClearedAmedica Drug Screen THC/Coc, OP1300, PPX, Oxy, Bar/Bzo Test
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 May 17, 2004 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 17, 2004
- Review
- 84 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.
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 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…
Read the full statement (255 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040464: Amedica Drug Screen THC/Coc, OP1300, PPX, Oxy, Bar/Bzo Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040464
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026