Cleared Traditional

K010045 - INSTANT-VIEW PHENCYCLIDINE (PCP) URINE ...

K010045 · Alfa Scientific Designs, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
144d
Days
-
Risk

K010045 is an FDA 510(k) clearance for the INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K010045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2001
Decision Date May 29, 2001
Days to Decision 144 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
57d slower than avg
Panel avg: 87d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K010045.
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · Lin-Zhi International, Inc. · May 2002
PHENCYCLIDINE
K013096 · Abbott Laboratories · Mar 2002
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
K011730 · ACON Laboratories, Inc. · Aug 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047 · Alfa Scientific Designs, Inc. · May 2001
AT HOME DRUG TEST, MODEL 9133 T
K010651 · Phamatech · Mar 2001
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K000462 · Dade Behring, Inc. · Apr 2000