510(k) · Cleared
ClearedOnline Dat Phencyclidine Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jan 10, 2005 as substantially equivalent to K983704 (Roche Diagnostic Systems, Inc., 1999) after a 41-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jan 10, 2005
- Review
- 41 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920935 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K983704 | Modification to Abuscreen Online for PhencyclidineSummary page 1…: Enzyme immunoassay, Phencyclidine 3) Predicate We claim substantial equivalence to the currently marketed Abuscreen device OnLine Phencyclidine assay (K983704). Continued on next page… | 1999 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Phencyclidine Plus provides only a preliminary analytical test result. A more specific…
Read the full statement (111 words)
The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GS/MS) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043305: Online Dat Phencyclidine Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043305
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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