# K012541: Modification to:Fastix THC/Coc Drug Screen Dipstick Test, Fastix THC/Coc/Met Drug Screen Dipstick Test, Fastix Opi/Met

- Pathway: 510(k) (Special)
- Applicant: Branan Medical Corp.
- Decided: Sep 4, 2001 after 28 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 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.

Source page: https://510kreport.com/device/K012541
Methodology: https://510kreport.com/methodology