Modification to:fastix Thc/Coc Drug Screen Dipstick Test, Fastix Thc/Coc/Met Drug Screen Dipstick Test, Fastix Opi/Met

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K012541 ↗

FDA Product Code

LDJ

Device Class

Class II

Regulation

21 CFR Part 862.3870

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61

  Class II

  FDA 510(k) K022355 Active Cleared 30 Jul 2002

• Fastect II Ppx Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard

  Class II

  FDA 510(k) K122752 Active Cleared 30 Jan 2013

• Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21

  Class II

  FDA 510(k) K010734 Active Cleared 30 Jul 2001

• Monitect Barbiturates Drug Screen Test

  Class II

  FDA 510(k) K002337 Active Cleared 22 Nov 2000

• Oratect Oral Fluid Drug Screen Devices

  Class II

  FDA 510(k) K103227 Active Cleared 11 Apr 2012

• Branan Medical Corporation Monitect Cocaine Drug Screen Test

  Class II

  FDA 510(k) K002264 Active Cleared 27 Nov 2000

See all devices from Branan Medical Corp. →

• What substances does this test detect, and how quickly can results be obtained?

  This device detects cannabinoids (THC), opioids, and methadone metabolites in urine specimens using an enzyme immunoassay. As a rapid point-of-care test, it is designed for quick screening, though the exact timeframe for results isn’t specified in the data. It’s intended for clinical toxicology assessments in settings like laboratories or point-of-care environments.

• Are these dipstick tests reusable, and what is their sterility status?

  The Fastix tests are explicitly labeled as single-use, non-sterile dipstick devices. Each test is pre-packaged with a unique lot number for traceability, meaning they cannot be reused after one use. Sterility is not a requirement for this application, as the device is intended for use in clinical toxicology screening.

• How are these tests supplied, and what should I consider when storing them?

  The tests come in pre-packaged kits, each containing dipsticks with assigned lot numbers for traceability. Storage conditions aren’t detailed in the data, but since they’re non-sterile and single-use, they should be stored in a dry, cool environment (typically 2–25°C) away from direct sunlight or extreme humidity to preserve their integrity until use. Always follow the manufacturer’s instructions for optimal performance.

• What regulatory pathway was used for FDA clearance, and what does this mean for my facility?

  This device received FDA 510(k) clearance (K012541) under a Special 510(k) classification, determined to be substantially equivalent to a predicate device. The clearance was granted by the FDA’s Clinical Toxicology Advisory Committee in Texas. This means your facility can legally use it for its intended purpose—qualitative detection of cannabinoids, opioids, and methadone metabolites in urine—provided you comply with FDA quality system regulations (21 CFR Part 820).