Cleared Special

K041578 - QUICKSCREEN, MODELS 9177X AND 9178X

K041578 · Phamatech · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
88d
Days
-
Risk

K041578 is an FDA 510(k) clearance for the QUICKSCREEN, MODELS 9177X AND 9178X. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041578

510(k) Number K041578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date September 10, 2004
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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 K041578.
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
K042726 · Quest Diagnostics, Inc. · Jul 2005
RANDOX PHENCYCLIDINE ASSAY
K043071 · Randox Laboratories, Ltd. · Jan 2005
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · Roche Diagnostics Corp. · Jan 2005
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
PHENCYCLIDINE
K013096 · Abbott Laboratories · Mar 2002
K041578 · QUICKSCREEN, MODELS 9177X AND 9178X
Download PDF FDA Summary Phamatech