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510(k) K051577

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS by Immunalysis Corporation — Product Code LAF

K051577 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS". The FDA issued a decision of Substantially Equivalent on October 4, 2005. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Immunalysis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2005
Date Received
June 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Immunalysis Corporation

  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K232898 — Quantisal™ Oral Fluid Collection Device (November 21, 2023)
  • K223781 — Quantisal™ II Oral Fluid Collection Device (July 28, 2023)
  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (November 15, 2019)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)

Other clearances for product code LAF

  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (December 15, 2021)
  • K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus (July 31, 2020)
  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (March 18, 2016)
  • K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta (September 18, 2015)
  • K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclid (March 4, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
  • K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (March 21, 2014)

FDA data resources