# K133047: Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu

- Pathway: 510(k) (Traditional)
- Applicant: Biophor Diagnostics, Inc.
- Decided: Dec 18, 2014 after 447 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924446 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101753: Thermo Scientific Cedia Methamphetamine Oft Assay, Microgenics Corp. (2011) Summary page 4.
- K132688: Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ, Biochemical Diagnostics, Inc. (2013). Cleared while this submission was under review Summary page 4.

## Indications for use
The RapidFRET Oral Fluid Assay for MDMA is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Methylenedioxymethamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only. The RapidFRET Oral Fluid MDMA Calibrator Set and RapidFRET Oral Fluid MDMA Control Set are intended for use only with the RapidFRET Oral Fluid Assay for MDMA and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K133047
Methodology: https://510kreport.com/methodology