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510(k) K011545

VERDICT -II TCA, VERDICT-II MTD by Medtox Diagnostics, Inc. — Product Code LFG

K011545 is an FDA 510(k) premarket notification submitted by Medtox Diagnostics, Inc. for the device "VERDICT -II TCA, VERDICT-II MTD". The FDA issued a decision of Substantially Equivalent on June 8, 2001. The device falls under product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Medtox Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2001
Date Received
May 18, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

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)
  • K050394 — SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADON (October 25, 2005)
  • K033334 — PROFILE -ER (November 10, 2003)
  • K031032 — VERDICT II, PROFILE II (July 14, 2003)
  • K022141 — VERDICT-II (July 30, 2002)

Other clearances for product code LFG

  • K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptylin (August 18, 2015)
  • K142609 — CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (December 18, 2014)
  • K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (September 9, 2011)
  • K072062 — UCP MULTIPLE DRUG SCREEN TEST CUPS (September 20, 2007)
  • K061457 — UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (August 21, 2006)
  • K021526 — ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (July 17, 2002)
  • K980249 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (March 13, 1998)
  • K870823 — EMIT NORTRIPTYLINE ASSAY (March 20, 1987)
  • K861155 — EMIT DESIPRAMINE ASSAY (May 2, 1986)
  • K853113 — TD TRICYCLIC ANTIDEPRESSANTS (August 12, 1985)

FDA data resources