510(k) · Cleared
ClearedOral Fluid Phencyclidine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jan 25, 2011 as substantially equivalent to K000399 (OraSure Technologies, Inc., 2000) after a 397-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jan 25, 2011
- Review
- 397 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000399 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000399 STC PCP Intercept Micro-Plate Eia, Model 11541OraSure Technologies, Inc. · 2000
- This deviceK093989 Oral Fluid PhencyclidineRoche Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541 | OraSure Technologies, Inc. | 2000 | — |
| 0 (this device) | K093989 | Oral Fluid Phencyclidine | Roche Diagnostics | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCM device
- #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541Summary page 2…for similar use. Most notably, we claim substantial equivalence to the currently marketed PCP Intercept® Micro-Plate EIA assay (K000399). Comparison Table Feature Roche Oral Fluid Phencyclidines Assay… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K000399.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LCM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LCM
Too few LCM 510(k)s in any year since 2007 to give a median.
Recalls per year · LCM
No recall names LCM since 2007.
Adverse event reports per year · LCM
2in 2019
MAUDE reports naming product code LCM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (255 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093989: Oral Fluid Phencyclidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093989
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026