510(k) Report

510(k) · Cleared

Cleared

Profile-II Model 600582

K982211510(k) TraditionalCleared Jul 29, 199836-day reviewClass II21 CFR 862.3870

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtox Diagnostics, Inc. · DKE Reagents, Test, Tetrahydrocannabinol

Cleared on Jul 29, 1998 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jul 29, 1998
Review
36 days
Class
Class II
Product code
DKE
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K982211Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DKE devices

DKE Reagents, Test, Tetrahydrocannabinol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKE

FDA has decided no DKE device since 2007.

Median 510(k) review, days · DKE

Too few DKE 510(k)s in any year since 2007 to give a median.

Recalls per year · DKE

No recall names DKE since 2007.

Adverse event reports per year · DKE

No MAUDE report names DKE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations: THC Tetrahydrocannabinol 50 ng/mL COoC Cocaine (Benzoylecgonine) 300 ng/mL OPS Opiates (Codeine/Morphine) 300 ng/mL AMP Amphetamine 1000 ng/mL PCP Phencyclidine 25 ng/mL This…

Read the full statement (140 words)

PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:

THC Tetrahydrocannabinol 50 ng/mL

COoC Cocaine (Benzoylecgonine) 300 ng/mL

OPS Opiates (Codeine/Morphine) 300 ng/mL

AMP Amphetamine 1000 ng/mL

PCP Phencyclidine 25 ng/mL

This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.

PROFILE-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Medtox Diagnostics, Inc.

22 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in DKE

The DKE category page

  • K003687Verdict II THC/Coc/Opi/Amp, Verdictii THC/Coc/Opi,Verdict II THC/Coc/Amp,Verdict II THC/Coc/PCP,Verdict II…Medtox Diagnostics, Inc. · 2000
  • K994405Instant-View Marijuana Urine Cassette TestAlfa Scientific Designs, Inc. · 2000
  • K992068Status Stik, Accusign StikPrinceton BioMeditech Corp. · 1999
  • K991751Status Cup Accusign CupPrinceton BioMeditech Corp. · 1999
  • K991078Accusign DOA8, DOA8 Panel, THC/Opi/Coc/Amp/Bzo/Bar/Tca/PCP, Biosign DOA8, THC/Opi/Coc/Amp/Bzo/Bar/Tca/Pap…Princeton BioMeditech Corp. · 1999

https://510kreport.com/device/K982211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982211: Profile-II Model 600582.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982211

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026