# K093989: Oral Fluid Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jan 25, 2011 after 397 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: 1 generation back to K000399 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000399: STC PCP Intercept Micro-Plate Eia, Model 11541, OraSure Technologies, Inc. (2000) Summary page 2.

## Indications for use
DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS. DAT Oral Fluid Phencyclidine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device. The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device. The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

Source page: https://510kreport.com/device/K093989
Methodology: https://510kreport.com/methodology