Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K053337 ↗

FDA Product Code

DKZ

Device Class

Class II

Regulation

21 CFR Part 862.3100

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What clinical applications is this reagent cartridge designed for, and how does it differ from general urine drug screens?

  This cartridge is specifically designed for clinical toxicology applications, particularly to detect amphetamine derivatives like methylenedioxymethamphetamine (MDMA) and related compounds in human urine. Unlike broader urine drug screens, it provides qualitative and semiquantitative results at cutoff thresholds of 300 ng/mL or 500 ng/mL, allowing for more precise identification of ecstasy-related substances. It is not intended for general drug screening but rather for targeted toxicology testing.

• Is this cartridge reusable, or is it meant for single-use only?

  The Dimension Urine Ecstasy Screen Flex Reagent Cartridge (Model DF 109) is explicitly designed for single-use only. It is supplied as a prepackaged reagent in an eight-well plastic cartridge, which must be discarded after a single use to ensure accuracy and prevent contamination.

• What system is required to use this cartridge, and can it be used with other clinical chemistry analyzers?

  This cartridge is exclusively compatible with the Dade Behring Dimension clinical chemistry system. It is not designed for use with other analyzers, and attempting to use it on a different system may yield unreliable or invalid results. Always verify system compatibility before use.

• How should this cartridge be stored, and are there any special handling instructions?

  The cartridge must be stored according to the manufacturer’s instructions to maintain its integrity and performance. While the data does not specify exact storage conditions (e.g., temperature or humidity), it is critical to follow Dade Behring’s guidelines to prevent degradation. Avoid exposure to extreme temperatures, moisture, or direct sunlight, and ensure it remains in its original packaging until use.

• What cutoff thresholds does this cartridge use for detecting MDMA, and how does that compare to other similar tests?

  The cartridge provides cutoff thresholds of 300 ng/mL or 500 ng/mL for detecting methylenedioxymethamphetamine (MDMA) and related compounds. These thresholds are higher than some general urine drug screens, which may use lower cutoffs (e.g., 200 ng/mL), making this test more specific for ecstasy-related substances while balancing sensitivity. The choice of threshold helps reduce false positives for non-MDMA amphetamines.