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Quickscreen Pro Multi Drug Screening Test, Model 9153 PAT04

by Phamatech 510(k)

Active United States

510(k) K000131

Overview

The Quickscreen Pro Multi Drug Screening Test, Model 9153 PAT04, is an enzyme immunoassay device used for the detection of cannabinoids. It functions as a screening test to identify the presence of specific substances within clinical toxicology applications.

This device is manufactured by Phamatech and has received FDA 510(k) clearance. It is classified as a Class II device under regulation number 862.3870.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK000131 Date4 Feb 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LDJ
Device Class
Class II
Regulation
21 CFR Part 862.3870
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Quickscreen Pro Model 9153 PAT04?

    This device is an enzyme immunoassay used for the detection of cannabinoids. It is designed to function as a screening test to identify the presence of these specific substances within clinical toxicology applications.

  • What is the regulatory classification of this screening test?

    The Quickscreen Pro Model 9153 PAT04 is classified as a Class II device under regulation number 862.3870. It has received FDA 510(k) clearance for its intended use in clinical toxicology.

  • Who is the manufacturer of this device?

    The device is manufactured by Phamatech, located in San Diego, California. The company is the applicant responsible for the FDA 510(k) clearance associated with this specific model.