Cleared Traditional

K043071 - RANDOX PHENCYCLIDINE ASSAY

K043071 · Randox Laboratories, Ltd. · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jan 2005

Decision

80d

Days

Risk

K043071 is an FDA 510(k) clearance for the RANDOX PHENCYCLIDINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 27, 2005 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 - K043071

510(k) Number	K043071 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 08, 2004
Decision Date	January 27, 2005
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

9d faster than avg

Panel avg: 89d · This submission: 80d

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 87

Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K043071.

VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V

K062094 · Ortho-Clinical Diagnostics, Inc. · Nov 2006

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

K060353 · Acro Biotech, LLC · May 2006

QUEST DIAGNOSTICS HAIRCHECK-DT (PCP

K042726 · Quest Diagnostics, Inc. · Jul 2005

ONLINE DAT PHENCYCLIDINE PLUS

K043305 · Roche Diagnostics Corp. · Jan 2005

QUICKSCREEN, MODELS 9177X AND 9178X

K041578 · Phamatech · Sep 2004

AMEDICA DRUG SCREEN PHENCYCLIDINE TEST

K023109 · Amedica Biotech, Inc. · Dec 2002

FDA 510(k) Resources - Chemistry

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

Manufacturer of K043071

Randox Laboratories, Ltd.

Crumlin · GB

P. ARMSTRONG

Regulatory profile

116 submissions 115 cleared

99% clearance rate · Active in Chemistry

View all devices by Randox Laboratories, Ltd. →

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 27, 2005. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026