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510(k) K050394

SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS by Medtox Diagnostics, Inc. — Product Code DKZ

K050394 is an FDA 510(k) premarket notification submitted by Medtox Diagnostics, Inc. for the device "SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS". The FDA issued a decision of Substantially Equivalent on October 25, 2005. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Medtox Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2005
Date Received
February 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Medtox Diagnostics, Inc.

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K100951 — MEDTOX BUPRENORPHINE TEST (October 18, 2010)
  • K100023 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM (April 5, 2010)
  • K091454 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM (July 24, 2009)
  • K080635 — MEDTOXSCAN (February 13, 2009)
  • K060351 — MEDTOX OXYCODONE (May 12, 2006)
  • K033334 — PROFILE -ER (November 10, 2003)
  • K031032 — VERDICT II, PROFILE II (July 14, 2003)
  • K022141 — VERDICT-II (July 30, 2002)
  • K020787 — VERDICT-II PROPOXYPHENE (May 2, 2002)

Other clearances for product code DKZ

  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources