Cleared Special

K000131 - QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04

K000131 is an FDA 510(k) clearance for QUICKSCREEN PRO MULTI DRUG SCREENING TEST, manufactured by Phamatech. The device is a Class 2 Toxicology device with product code LDJ cleared through the Special 510(k) pathway after a 17-day FDA review.

K000131 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
17d
Days
Class 2
Risk

K000131 is an FDA 510(k) clearance for the QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 - K000131

510(k) Number K000131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date February 04, 2000
Days to Decision 17 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
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K000131.
ADVANTAGE THC TEST
K001567 · Advantage Diagnostics Corp. · Jun 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · Roche Diagnostics Corp. · Apr 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · Dade Behring, Inc. · Apr 2000
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
K993961 · American Bio Medica Corp. · Jan 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · Syva Co. · Jan 2000
AT HOME DRUG TEST, MODEL 9078
K994220 · Phamatech · Dec 1999
K000131 · QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
Download PDF FDA Summary Phamatech