Cleared Traditional

K043305 - ONLINE DAT PHENCYCLIDINE PLUS

K043305 · Roche Diagnostics Corp. · Toxicology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Jan 2005

Decision

41d

Days

Risk

K043305 is an FDA 510(k) clearance for the ONLINE DAT PHENCYCLIDINE PLUS. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 10, 2005 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K043305

510(k) Number	K043305 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 30, 2004
Decision Date	January 10, 2005
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

46d faster than avg

Panel avg: 87d · This submission: 41d

Pathway characteristics

Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code	LCM Enzyme Immunoassay, Phencyclidine
Device Class	-

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 86

Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K043305.

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

K060353 · Acro Biotech, LLC · May 2006

QUEST DIAGNOSTICS HAIRCHECK-DT (PCP

K042726 · Quest Diagnostics, Inc. · Jul 2005

RANDOX PHENCYCLIDINE ASSAY

K043071 · Randox Laboratories, Ltd. · Jan 2005

QUICKSCREEN, MODELS 9177X AND 9178X

K041578 · Phamatech · Sep 2004

AMEDICA DRUG SCREEN PHENCYCLIDINE TEST

K023109 · Amedica Biotech, Inc. · Dec 2002

PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011

K020254 · Lin-Zhi International, Inc. · May 2002

FDA 510(k) Resources - Toxicology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K043305

Roche Diagnostics Corp.

Indianapolis, IN · US

DIMITRIS DEMIRTZOGLOU

Regulatory profile

264 submissions 263 cleared

100% clearance rate · Active in Toxicology

View all devices by Roche Diagnostics Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 10, 2005. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: June 2026.

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