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510(k) K151348

Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) by Healgen Scientific,, LLC — Product Code LFG

K151348 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)". The FDA issued a decision of Substantially Equivalent on August 18, 2015. The device falls under product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2015
Date Received
May 20, 2015
Clearance Type
Traditional
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 Healgen Scientific,, LLC

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  • K253705 — Healgen® Accurate Oral Fluid Drug Test (March 16, 2026)
  • K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Dru (February 12, 2026)
  • K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Te (December 23, 2025)
  • K251800 — Healgen® URS Test Strips (December 23, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Dru (December 17, 2024)
  • K240949 — Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid (May 13, 2024)
  • K232377 — Healgen Rapid COVID-19 Antigen Test (April 19, 2024)
  • K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Te (April 12, 2024)

Other clearances for product code LFG

  • 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)
  • K011545 — VERDICT -II TCA, VERDICT-II MTD (June 8, 2001)
  • 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