Urine Cocaine Metabolite (Coc) Screen Flex Reagent Cartridge, Catalog No. DF 92A

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

510(k) Number

K000467 ↗

FDA Product Code

DIO

Device Class

Class II

Regulation

21 CFR Part 862.3250

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What clinical setting is this device intended for and how does it help in patient assessment?

  This device is designed for use in clinical toxicology settings, where it serves as a rapid diagnostic tool to identify recent cocaine use or potential overdose. It detects benzoylecgonine, the primary metabolite of cocaine, in human urine through an enzyme immunoassay. By measuring metabolite concentrations at cutoff thresholds of 150 or 300 ng/mL, it provides qualitative and semi-quantitative results to aid clinicians in assessing patients who may have ingested cocaine.

• Is this device single-use or reusable, and what preparation is required before use?

  The URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE is designed for single-use only. It is supplied as a sterile, ready-to-use reagent cartridge and requires no additional preparation beyond insertion into the Dimension clinical chemistry system. No further handling or activation is needed before testing.

• What cutoff thresholds does this device use to determine cocaine metabolite levels, and how does that affect interpretation?

  The device measures benzoylecgonine concentrations at two cutoff thresholds: 150 ng/mL and 300 ng/mL. These thresholds help clinicians distinguish between low-level exposure and higher concentrations, which may indicate more recent or significant cocaine use. The semi-quantitative results assist in risk stratification and clinical decision-making.

• How is this device supplied, and what storage requirements should be followed?

  The device is supplied as a sterile, ready-to-use reagent cartridge (Catalog No. DF 92A) by Dade Behring, Inc.. While specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data, most enzyme immunoassay cartridges require protection from extreme temperatures and light. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain accuracy and sterility.

• What system is required to operate this device, and does it have any special handling considerations?

  This cartridge is intended exclusively for use on the Dimension clinical chemistry system. It does not require additional reagents or preparation beyond insertion into the system. Since it is a single-use cartridge, proper disposal after testing is essential to prevent contamination and ensure compliance with laboratory protocols.