Product code LAF— Clinical Toxicology
ACCUSIGN MET/BIOSIGN MET
- Classification name
- Gas Chromatography, Methamphetamine
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Total cleared
- 49
- First cleared
- Most recent
Market context for product code LAF
FDA has cleared devices under product code LAF between 1989 and 2021, filed by 32 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2020
- 2017
- 2016
- 2015
- 2014
- 2012
- 2011
- 2008
- 2006
- 2005
- 2003
- 2002
- 2001
- 2000
Top applicants under product code LAF
Recent clearances under product code LAF
- K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
- K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
- K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
- K170222 — Rapid Tox Cup II
- K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
- K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
- K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
- K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
- K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
- K111927 — PSYCHEMEDICS METHAMPHETAMINE EIA
- K113661 — LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
- K112236 — WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
- K101973 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
- K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
- K093884 — ROCHE FLUDI METHAMPHETAMINE
- K080455 — RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
- K080381 — QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
- K062242 — METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS
- K051577 — IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
- K033299 — ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
- K023837 — LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
- K023101 — AMEDICA DRUG SCREEN METHAPHETAMINE TEST
- K022589 — ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
- K012998 — AMPHETAMINE/METHAMPHETAMINE
- K012585 — AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
- K011672 — ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
- K011610 — LIVESURE METHAMPHETAMINE SCREEN TESTS
- K003845 — MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
- K003847 — MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
- K010496 — CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
- K010836 — AT WORK DRUG TEST, MODEL 9147T AWT
- K003352 — ESCREEN SYSTEM
- K993852 — FIRST CHECK HOME DRUG TEST PANEL 4
- K000096 — ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
- K000452 — SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
- K000979 — REDI-SCREEN
- K993208 — STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
- K000447 — QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
- K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
- K992634 — IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
- K994233 — AT HOME DRUG TEST, MODEL 9068
- K991504 — REDI-TEST METHAMPHETAMINE
- K983189 — DBEST METHAMPHETAMINES TEST KIT
- K972556 — QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
- K961249 — ACCUSIGN MET/BIOSIGN MET
- K910043 — TENONE(TM) METHAMPHETAMINE
- K904413 — CEDIA(TM) PHENOBARBITAL ASSAY
- K885071 — COAT-A-COUNT METHAMPHETAMIN #TKMA1
Data sourced from openFDA. This site is unofficial and independent of the FDA.