510(k) Report

FDA applicant

Medtox Diagnostics, Inc.

Burlington, NC22 decisions1998–20261 recall

FDA records 22 decisions for Medtox Diagnostics, Inc. (Burlington, NC) from 1998 to 2026: 22 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DIS (Enzyme Immunoassay, Barbiturate). Its devices cite 9 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Medtox Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 22010: 22026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtox Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtox Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DJGEnzyme Immunoassay, Opiates7decisions
  • DISEnzyme Immunoassay, Barbiturate4decisions
  • DKZEnzyme Immunoassay, Amphetamine3decisions
  • DKEReagents, Test, Tetrahydrocannabinol2decisions
  • DJCThin Layer Chromatography, Methamphetamine2decisions
  • LDJEnzyme Immunoassay, Cannabinoids1decision

Also: LCM (1), JXN (1), LFG (1).

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 20093cite it
  • K050394Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine &…Medtox Diagnostics, Inc. · 20053cite it
  • K080635MedtoxscanMedtox Diagnostics, Inc. · 20093cite it
  • K060351Medtox OxycodoneMedtox Diagnostics, Inc. · 20062cite it
  • K010226Verdict -II MethamphetamineMedtox Diagnostics, Inc. · 20011cites it
  • K002331Profile-ERMedtox Diagnostics, Inc. · 20011cites it

What has FDA decided for it lately?

  • K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
  • K100951Medtox Buprenorphine TestMedtox Diagnostics, Inc. · 2010
  • K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc. · 2010
  • K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
  • K080635MedtoxscanMedtox Diagnostics, Inc. · 20091 recall
  • K060351Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
  • K050394Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine &…Medtox Diagnostics, Inc. · 2005
  • K033334Profile -ERMedtox Diagnostics, Inc. · 2003

All 22 as Medtox Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080635PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of…Apr 5, 2013Class II