Cleared Special

K993165 - QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178

K993165 is an FDA 510(k) clearance for QUICKSCREEN PRO MULTI DRUG SCREEN, manufactured by Phamatech. The device is a Class 2 Toxicology device with product code DJG cleared through the Special 510(k) pathway after a 28-day FDA review.

K993165 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
28d
Days
Class 2
Risk

K993165 is an FDA 510(k) clearance for the QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on October 20, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. 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 - K993165

510(k) Number K993165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date October 20, 1999
Days to Decision 28 days
Submission Type Special
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
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K993165.
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · Roche Diagnostics Corp. · Nov 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · Syntron Bioresearch, Inc. · Oct 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · Syntron Bioresearch, Inc. · Oct 1999
REDI-TEST OPIATES
K991883 · Advantage Diagnostics Corp. · Sep 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · Princeton BioMeditech Corp. · Aug 1999
RAPIDONE - OPIATES TEST
K990820 · American Bio Medica Corp. · Jul 1999
K993165 · QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
Download PDF FDA Summary Phamatech