510(k) · Cleared
ClearedAmedica Drug Screen Mdma-Bar-Bzo-MTD-Tca Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Biotech, Inc. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Oct 17, 2003 after a 157-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 17, 2003
- Review
- 157 days
- Class
- Class II
- Product code
- DJC
- 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 DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Instant-View Drug Screen MDMA, Barbiturate, Benzodiazepine, Methadone, TCA Test Named without a submission number |
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 DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration. MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml BAR secobarbital 300 ng/ml RZO oxazepam 300 ng/ml MTD methadone 300 ng/ml TCA nortriptyline 1000 ng/ml This test kit is used to obtain a visual, qualitative…
Read the full statement (76 words)
The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration.
MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml
BAR secobarbital 300 ng/ml
RZO oxazepam 300 ng/ml
MTD methadone 300 ng/ml
TCA nortriptyline 1000 ng/ml
This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not for over-the-counter sale.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031497 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031497: Amedica Drug Screen Mdma-Bar-Bzo-MTD-Tca Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031497
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