510(k) · Cleared
ClearedPhencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on May 10, 2002 as substantially equivalent to K935320 (Diagnostic Reagents, Inc., 1993) after a 106-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- May 10, 2002
- Review
- 106 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935320 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK935320 Phencyclidine Eia AssayDiagnostic Reagents, Inc. · 1993
- This deviceK020254 Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011Lin-Zhi International, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK033866 Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 &…Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K033866Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)Lin-Zhi International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935320 | Phencyclidine Eia Assay | Diagnostic Reagents, Inc. | 1993 | — |
| 0 (this device) | K020254 | Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011 | Lin-Zhi International, Inc. | 2002 | — |
| +1 | K033866 | Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test… | Lin-Zhi International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 |
|---|---|---|---|
| * | K935320 | Phencyclidine Eia AssaySummary page 1…Immunoassay is substantially equivalent to the Phencyclidine Enzyme Immunoassay by Diagnostic Reagents Inc. (now Microgenics, Inc.), cleared under premarket notification K935320. LZI’s Phencyclidine Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, dev… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033866 | Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits) | 2004 | 0 |
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?
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 Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of phencyclidine (PCP) in human urine.
The Phencyclidine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement 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/K020254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020254: Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020254
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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