# K122703: Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and  Rapidease Oral Fluid Collector

- Pathway: 510(k) (Traditional)
- Applicant: Biophor Diagnostics, Inc.
- Decided: Apr 25, 2013 after 233 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000399 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101746: Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay, Microgenics Corp. (2011) Summary page 1.

## Most influential descendants
- K181135: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (2019), 1 descendant of its own
- K203489: SEFRIA PCP Oral Fluid Enzyme Immunoassay (2021), 0 descendants of its own

## Indications for use
The RapidFRET Oral Fluid Assay for PCP 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 Phencyclidine at 10 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 PCP Calibrator Set and RapidFRET Oral Fluid PCP Control Set are intended for use only with the RapidFRET Oral Fluid Assay for PCP 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/K122703
Methodology: https://510kreport.com/methodology