510(k) Report

510(k) · Cleared

Cleared

Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip)

K003845510(k) TraditionalCleared May 29, 2001168-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

Alfa Scientific Designs, Inc. · LAF Gas Chromatography, Methamphetamine

Cleared on May 29, 2001 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided
May 29, 2001
Review
168 days
Class
Class II
Product code
LAF
Recalls
None
Predicates
0

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2016: 1 descendant cleared2018: 3 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK003845 Modification to Instant-View Methamphetamine (Meth 1000) Urine Test…Alfa Scientific Designs, Inc. · 2001
  2. Descendant · cites it directly · 16 of its ownK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
  3. Descendant · 2 generations on · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
  4. Descendant · 3 generations on · 12 of its ownK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
  5. Descendant · 4 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
  6. Descendant · 5 generations on · 8 of its ownK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12013: 12016: 12018: 32019: 12023: 12024: 22025: 42026: 2
2007high 4 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 17 · See all
  • K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc. · 2007 · cites it directly16descendants
  • K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Alfa Scientific Designs, Inc. · 2016 · 2 generations on13descendants
  • K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…Alfa Scientific Designs, Inc. · 2018 · 3 generations on12descendants
  • K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd. · 2019 · 4 generations on9descendants
  • K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…Hangzhou AllTest Biotech Co., Ltd. · 2023 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003845Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip)Alfa Scientific Designs, Inc.2001—
+1K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test…Alfa Scientific Designs, Inc.2007—
+2K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug…Alfa Scientific Designs, Inc.2016—
+3K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)…Alfa Scientific Designs, Inc.2018—
+4K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and…Hangzhou AllTest Biotech Co., Ltd.2019—
+5K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel…Hangzhou AllTest Biotech Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201310
201610
201830
201910
202310
202420
202540
202620
FIG. 1 — Lineage of K003845, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc.200716

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?

  • Of its descendants, K063545 (Alfa Scientific Designs, Inc., 2007) has gone furthest, with 16 descendants of its own.

How does its category compare?

All LAF devices

LAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Alfa Scientific Designs, Inc.

44 FDA decisions under this applicant name. See the company

  • K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc. · 2026
  • K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine…Alfa Scientific Designs, Inc. · 2018
  • K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018
  • K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)Alfa Scientific Designs, Inc. · 2016
  • K131645Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)Alfa Scientific Designs, Inc. · 2013

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/K003845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003845: Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003845

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026