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At Home Drug Test, Model 9073 T

by Phamatech 510(k)

Active United States

510(k) K010650

Overview

An enzyme immunoassay for cocaine and cocaine metabolites, benzoylecgonine, in serum, plasma, and urine. It is a device intended to measure cocaine and a cocaine metabolite for use in the diagnosis and treatment of cocaine use or overdose.

The test is supplied for home use by lay individuals to assist in drug abuse prevention. It utilizes visual color sandwich immunochemical technology where specific antibody-drug-antibody complexes form in the presence of analyte. The device has FDA 510(k) clearance under K010650 and is classified as a Class II medical device under regulation number 862.3250.

AI-generated from registry data, 24 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 NumberK010650 Date30 Mar 2001ClearedStatusActive

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
DIO
Device Class
Class II
Regulation
21 CFR Part 862.3250
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the AT HOME DRUG TEST, MODEL 9073 T used for?

    It is an enzyme immunoassay designed to measure cocaine and its metabolite benzoylecgonine in serum, plasma, and urine, intended to assist in the diagnosis and treatment of cocaine use or overdose.

  • Who is intended to use the AT HOME DRUG TEST, MODEL 9073 T and how is it supplied?

    The test is supplied for home use by lay individuals to assist in drug abuse prevention, utilizing visual color sandwich immunochemical technology where specific antibody-drug-antibody complexes form in the presence of analyte.

  • What regulatory clearance does the AT HOME DRUG TEST, MODEL 9073 T have?

    The device has FDA 510(k) clearance under K010650 and is classified as a Class II medical device under regulation number 862.3250.