510(k) Report

510(k) · Cleared

Cleared

Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050

K080455510(k) TraditionalCleared Dec 31, 2008315-day reviewClass II21 CFR 862.3610

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

Quantrx Biomedical Corporation · LAF Gas Chromatography, Methamphetamine

Cleared on Dec 31, 2008 as substantially equivalent to K011672 (ACON Laboratories, Inc., 2001) after a 315-day review. Its family tree reaches back 2 generations to 1996.

Decided
Dec 31, 2008
Review
315 days
Class
Class II
Product code
LAF
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K961249 (1996). No later device cites it as a predicate yet.

K961249 · Accusign Met/Biosign Met · Princeton BioMeditech Corp. · 1996K011672 · Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device · ACON Laboratories, Inc. · 20011995200020052010
K011672 · Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device · ACON Laboratories, Inc. · 2001K961249 · Accusign Met/Biosign Met · Princeton BioMeditech Corp. · 19960
  1. Root · 2 generations backK961249 Accusign Met/Biosign MetPrinceton BioMeditech Corp. · 1996
  2. 1 generation backK011672 Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step…ACON Laboratories, Inc. · 2001
  3. This deviceK080455 Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model…Quantrx Biomedical Corporation · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K961249Accusign Met/Biosign MetPrinceton BioMeditech Corp.1996—
−1K011672Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step…ACON Laboratories, Inc.2001—
0 (this device)K080455Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050Quantrx Biomedical Corporation2008—
FIG. 1 — Lineage of K080455, 1996–2008Source: FDA 510(k) summaries, read by 510(k) Report · 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LAF device

  1. #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K011672Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test…
Summary page 2
…parison to Predicate Device Both the RapidSense TM Drugs of Abuse Methamphetamine (MET) 1000 device and the ACON mAMP One Step Methamphetamine Test Device, cleared under K01 1672 have the indications for use and same cut-off of 1000 ng/mL. Both assays are lateral flow competitive immunoassays which provide…
ACON Laboratories, Inc.2001—

Also cleared against K011672: 2 other devices →

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.

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
  • None of the 2 ancestors has a recall.
  • 2 other devices also cite its predicate K011672.

How does its category compare?

All LAF devices

LAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LAF

2in 2021

2008: 22011: 42012: 22014: 22015: 32016: 12017: 12020: 12021: 2
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LAF

43in 2015

2011: 345 days median2015: 43 days median
2007high 345 (2011) · low 43 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LAF

No recall names LAF since 2007.

Adverse event reports per year · LAF

No MAUDE report names LAF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20100—00
2011434500
20122—00
20130—00
20142—00
201534300
20161—00
20171—00
20180—00
20190—00
20201—00
20212—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The RapidSense TM Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to…

Read the full statement (129 words)

The RapidSense TM Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methamphetamine and cause false positive results.

Indications for use as stated in the FDA summary.

Also cleared against K011672

2 other devices cite the same predicate.

  • K050594Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & PhencyclidineNano-Ditech Co. · 2005
  • K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test DeviceAcon Laboratories Co. · 2002

More from Quantrx Biomedical Corporation

4 FDA decisions under this applicant name. See the company

  • K080436Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052Quantrx Biomedical Corporation · 2009
  • K080431Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054Quantrx Biomedical Corporation · 2009
  • K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007

Recent decisions in LAF

The LAF category page

  • K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
  • K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group · 2020
  • K170222Rapid Tox Cup IIAmerican Bio Medica Corp. · 2017
  • K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016

https://510kreport.com/device/K080455 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080455: Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080455

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