510(k) Report

510(k) · Cleared

Cleared

Instant-View Cocaine (Benzylecgonine) Urine Dip Strip Test

K994403510(k) TraditionalCleared Aug 14, 2000230-day reviewClass II21 CFR 862.3250

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. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on Aug 14, 2000 as substantially equivalent to K971926 (Drial Consultants, Inc., 1997) after a 230-day review. Its family tree reaches back 1 generation to 1997. 17 later devices descend from it.

Decided
Aug 14, 2000
Review
230 days
Class
Class II
Product code
DIO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K971926 (1997). 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 clearedK971926 · Quikstrip One Step Cocaine Test · Drial Consultants, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant K971926 · Quikstrip One Step Cocaine Test · Drial Consultants, Inc. · 19970+5
  1. Root · 1 generation backK971926 Quikstrip One Step Cocaine TestDrial Consultants, Inc. · 1997
  2. This deviceK994403 Instant-View Cocaine (Benzylecgonine) Urine Dip Strip TestAlfa Scientific Designs, Inc. · 2000
  3. Descendant · cites it directly · 16 of its ownK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
  4. Descendant · 2 generations on · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
  5. 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
  6. Descendant · 4 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
  7. 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
−1K971926Quikstrip One Step Cocaine TestDrial Consultants, Inc.1997—
0 (this device)K994403Instant-View Cocaine (Benzylecgonine) Urine Dip Strip TestAlfa Scientific Designs, Inc.2000—
+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 K994403, 1997–2026Source: 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), 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 DIO? 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 DIO device

  1. #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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? (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
*K971926Quikstrip One Step Cocaine Test
Summary page 1
…d devices for the similar intended use. The device used for comparison study is QuikStrip One Step Cocaine Test, manufactured by Syntron Bioresearch, Inc. with 510(K) #: K971926, Date of Approval: 07/14/97. Device Description This test is a one-step lateral flow chromatographic immunoassay. Intended Use…
Drial Consultants, Inc.1997—

Also cleared against K971926: 1 other device →

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?

  • Its one ancestor has no recall.
  • Of its descendants, K063545 (Alfa Scientific Designs, Inc., 2007) has gone furthest, with 16 descendants of its own.
  • 1 other device also cites its predicate K971926.

How does its category compare?

All DIO devices

DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIO

1in 2022

2009: 12011: 52012: 52013: 22014: 22015: 22016: 32017: 32018: 12020: 12021: 12022: 1
2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIO

267in 2017

2011: 65 days median2012: 139 days median2016: 88 days median2017: 267 days median
2007high 267 (2017) · low 65 (2011)2026

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

Recalls per year · DIO

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DIO

1in 2023

2011: 42014: 12015: 72016: 92017: 162018: 122019: 222022: 12023: 1
2007high 22 (2019) · low 0 (2007)2025

MAUDE reports naming product code DIO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
201156504
2012513900
20132—10
20142—01
20152—07
201638809
20173267016
20181—012
20190—022
20201—00
20211—00
20221—01
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

Instant-View Cocaine (Benzoylecgonine) Urine Dip Strip Test is a qualitative one step lateral flow,competitive binding immunoassay device intended to be used to detect Benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of-300-ng/ml. It is intended for health care professional use only. This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed…

Read the full statement (93 words)

Instant-View Cocaine (Benzoylecgonine) Urine Dip Strip Test is a qualitative one step lateral flow,competitive binding immunoassay device intended to be used to detect Benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of-300-ng/ml. It is intended for health care professional use only.

This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied-to-any-drug-of-abuse, particularly when preliminary positive resultfiused.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K971926

1 other device cites the same predicate.

  • K994398Instant-View Cocaine (Benzylecgonine) Urine Cassette TestAlfa Scientific Designs, Inc. · 2000

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 DIO

The DIO category page

  • K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp. · 2022
  • K211973DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021
  • K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020
  • K181499DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018
  • K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K994403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994403: Instant-View Cocaine (Benzylecgonine) Urine Dip Strip Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994403

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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