RapidFRET Oral Fluid Assay for Cocaine, Calibrator Set, Control Set

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

Full name

Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set, Rapidfret Oral Fluid Cocaine Control Set

510(k) Number

K142129 ↗

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 is the RapidFRET Oral Fluid Assay for Cocaine used for?

  The RapidFRET Oral Fluid Assay for Cocaine is an enzyme immunoassay designed to detect cocaine and its metabolites in human oral fluid. It uses competitive binding between an antibody labeled with a donor fluorophore and a cocaine conjugate labeled with an acceptor fluorophore, enabling rapid and sensitive detection. This assay is intended for use in central laboratories to support clinical toxicology evaluations.

• How is the RapidFRET Oral Fluid Assay supplied and what does it include?

  The assay is supplied as a ready-to-use system, including the RapidFRET Oral Fluid Assay for Cocaine itself, along with a calibrator set and a control set. These components are essential for validating the assay’s performance and ensuring accurate results. The system is specifically designed to operate on the RapidFRET Integrated Workstation.

• Is the RapidFRET Oral Fluid Assay single-use or reusable?

  The RapidFRET Oral Fluid Assay follows standard immunoassay protocols, which means it is intended for single-use only. Each assay kit is designed for one-time use to maintain accuracy and reliability, preventing cross-contamination or degradation of results from repeated use.

• What regulatory clearance does the RapidFRET Oral Fluid Assay hold?

  The RapidFRET Oral Fluid Assay for Cocaine, along with its calibrator and control sets, holds a 510(k) clearance (K142129) from the FDA, demonstrating substantial equivalence to a predicate device. This clearance confirms its compliance with FDA regulations under 21 CFR 862.3250 and its classification as a Class II medical device.

• How does the assay’s fluorescence technology improve detection?

  The assay employs a homogeneous time-resolved fluorescence (TRF) method, where competitive binding occurs between an antibody conjugated to a donor fluorophore and cocaine conjugated to an acceptor fluorophore. When cocaine or its metabolites are present, they compete with the labeled cocaine, reducing fluorescence signal. This technology allows for rapid, sensitive, and specific detection without the need for separation steps, improving both efficiency and accuracy in clinical settings.