510(k) · Cleared
ClearedPhencyclidine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Mar 13, 2002 as substantially equivalent to K904765 (Syva Co., 1990) after a 177-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 13, 2002
- Review
- 177 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904765 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK904765 Emit (R) II Phencyclidine AssaySyva Co. · 1990
- This deviceK013096 PhencyclidineAbbott Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904765 | Emit (R) II Phencyclidine Assay | Syva Co. | 1990 | — |
| 0 (this device) | K013096 | Phencyclidine | Abbott Laboratories | 2002 | — |
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 |
|---|---|---|---|
| * | K904765 | Emit (R) II Phencyclidine AssaySummary page 2…n be measured spectrophotdmetrically. Substantial Equivalence: The Phencyclidine assay is substantially equivalent to the Emit® II Phencyclidine assay (K904765) on the SYVA®-30R Analyzer. | Both assays yicld similar Performance Characteristics. Similarities: « Both assays are in vitro… | 1990 |
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.
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 assay is used for the qualitative analysis of phencyclidine in human urine with a cutoff of 25 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of phencyclidine use or overdose. The Phencyclidine assay is calibrated with phencyclidine and will detect phencyclidine and its metabolites and analogs. The Phencyclidine assay provides only a preliminary analytical test…
Read the full statement (116 words)
The Phencyclidine assay is used for the qualitative analysis of phencyclidine in human urine with a cutoff of 25 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of phencyclidine use or overdose.
The Phencyclidine assay is calibrated with phencyclidine and will detect phencyclidine and its metabolites and analogs.
The Phencyclidine assay 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 (GC/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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013096: Phencyclidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013096
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026