510(k) · Cleared
ClearedModification to:Fastix THC/Coc Drug Screen Dipstick Test, Fastix THC/Coc/Met Drug Screen Dipstick Test, Fastix Opi/Met
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Branan Medical Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Sep 4, 2001 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 4, 2001
- Review
- 28 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 Branan Medical Corporation Fastix™ Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of THC (11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid) and Benzoylecgonine (cocaine metabolite) in human urine. The cutoff concentrations are as follows: THC 11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml COC Benzoylecgonine 300 ng/ml The test kit is used to obtain a visual, qualitative result and is intended for…
Read the full statement (309 words)
The Branan Medical Corporation Fastix™ Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of THC (11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid) and Benzoylecgonine (cocaine metabolite) in human urine. The cutoff concentrations are as follows:
THC 11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
The Branan Medical Corporation Fastix™ Drug Screen THC/COC/MET Dipstick Test is an in vitro screen test for the rapid detection of THC, Cocaine and Methamphetamine in human urine. The cutoff concentrations are as follows:
THC 11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
MET D-Methamphetamine 1000 ng/ml
The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
The Branan Medical Corporation Fastix™ Drug Screen OPI/MET/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Methamphetamine THC, and Cocaine in human urine. The cutoff concentrations are as follows:
OPI Morphine 2000 ng/ml
MET D-Methamphetamine 1000 ng/ml
THC 11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
The Branan Medical Corporation Fastix™ Drug Screen OPI/AMP/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Amphetamine, THC and Cocaine in human urine. The cutoff concentrations are as follows:
OPI Morphine 2000 ng/ml
AMP Amphetamine 1000 ng/ml
THC 11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml
COC Benzoylecgonine 300 ng/ml
The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012541: Modification to:Fastix THC/Coc Drug Screen Dipstick Test, Fastix THC/Coc/Met Drug Screen Dipstick Test, Fastix Opi/Met.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012541
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026