510(k) · Cleared
ClearedRapid Barbiturate Test Strip and Test Card, Models 7015 and 7016
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icn Biomedicals, Inc. · DKX Thin Layer Chromatography, Barbiturate
Cleared on Jun 13, 2003 after a 143-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 13, 2003
- Review
- 143 days
- Class
- Class II
- Product code
- DKX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Applied Biotech Surestep T'Drug Screen Test Barbiturate 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 DKX devicesDKX Thin Layer Chromatography, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKX
FDA has decided no DKX device since 2007.
Median 510(k) review, days · DKX
Too few DKX 510(k)s in any year since 2007 to give a median.
Recalls per year · DKX
No recall names DKX since 2007.
Adverse event reports per year · DKX
No MAUDE report names DKX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 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 | 0 | — | 0 | 0 |
| 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test…
Read the full statement (202 words)
Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GCMS, must be used in order to obtain a confirmed analytical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030211: Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030211
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