510(k) Report

510(k) · Cleared

Cleared

One Step Urine Drug of Abuse: Phencyclidine (PCP) Test

K981363510(k) TraditionalCleared Dec 22, 1998251-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tcpi, Inc. · LCM Enzyme Immunoassay, Phencyclidine

Cleared on Dec 22, 1998 after a 251-day review. The FDA summary names no predicate by number.

Decided
Dec 22, 1998
Review
251 days
Class
Class U
Product code
LCM
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K981363Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

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.

How does its category compare?

All LCM devices

LCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCM

1in 2022

2009: 12010: 12011: 22012: 12013: 22014: 12015: 12017: 12019: 12021: 12022: 1
2007high 2 (2011) · low 0 (2007)2026

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

2011: 22012: 12019: 2
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code LCM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20101—00
20112—02
20121—01
20132—00
20141—00
20151—00
20160—00
20171—00
20180—00
20191—02
20200—00
20211—00
20221—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

TCPI’s One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result…

Read the full statement (104 words)

TCPI’s One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicateds. TCPI’s One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Tcpi, Inc.

14 FDA decisions under this applicant name. See the company

  • K972960Health Check Uri-Test Protein in UrineTcpi, Inc. · 1998
  • K981197One Step Urine Drug of Abuse Amphetamine TestTcpi, Inc. · 1998
  • K980776One Step Urine Drug of Abuse: Benzodiazepine TestTcpi, Inc. · 1998
  • K951853One Step Urine Drug of Abuse Cannabinoid Test (THC)Tcpi, Inc. · 1996
  • K954968Health Check Uri-Test Glucose in Urine TestTcpi, Inc. · 1996

Recent decisions in LCM

The LCM category page

  • K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation · 2022
  • K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019
  • K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc. · 2017
  • K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2015

https://510kreport.com/device/K981363 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981363: One Step Urine Drug of Abuse: Phencyclidine (PCP) Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981363

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026