510(k) · Cleared

Cleared

Instant-View Amphetamine Urine Cassette Test

K994395510(k) TraditionalCleared Aug 7, 2000223-day reviewClass II21 CFR 862.3100

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. · DKZ Enzyme Immunoassay, Amphetamine

Cleared on Aug 7, 2000 as substantially equivalent to K971218 (Drial Consultants, Inc., 1997) after a 223-day review. Its family tree reaches back 1 generation to 1997. 17 later devices descend from it.

Decided: Aug 7, 2000
Review: 223 days
Class: Class II
Product code: DKZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971218 (1997). 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971218 Quikstrip One Step Amphetamine TestDrial Consultants, Inc. · 1997
This deviceK994395 Instant-View Amphetamine Urine Cassette TestAlfa Scientific Designs, Inc. · 2000
Descendant · cites it directly · 16 of its ownK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
Descendant · 2 generations on · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
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
Descendant · 4 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
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

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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971218	Quikstrip One Step Amphetamine Test	Drial Consultants, Inc.	1997	—
0 (this device)	K994395	Instant-View Amphetamine Urine Cassette Test	Alfa Scientific Designs, Inc.	2000	—
+1	K063545	Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test…	Alfa Scientific Designs, Inc.	2007	—
+2	K152122	Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug…	Alfa Scientific Designs, Inc.	2016	—
+3	K173303	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)…	Alfa Scientific Designs, Inc.	2018	—
+4	K182738	Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and…	Hangzhou AllTest Biotech Co., Ltd.	2019	—
+5	K233019	AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel…	Hangzhou AllTest Biotech Co., Ltd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0
2013	1	0
2016	1	0
2018	3	0
2019	1	0
2023	1	0
2024	2	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K994395, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DKZ? 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 DKZ device

#1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K971218	Quikstrip One Step Amphetamine Test Summary page 1 …evices for the similar intended use. The device used for comparison study is QuikStrip OneStep Amphetamine Test, manufactured by Syntron Bioresearch, Inc. with 510(K) #: K971218, Date of Approval: 05/30/97. Predicate Device This test is a one-step lateral flow chromatographic Device Description immunoas…	Drial Consultants, Inc.	1997	—

Also cleared against K971218: 2 other devices →

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.

Number	Device	Applicant	Decided	Descendants
K063545	Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…	Alfa Scientific Designs, Inc.	2007	16

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.
2 other devices also cite its predicate K971218.

How does its category compare?

All DKZ devices

DKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKZ

1in 2024

2007high 8 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKZ

180in 2019

2007high 233 (2010) · low 55 (2012)2026

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

Recalls per year · DKZ

1in 2017

2007high 5 (2009) · low 0 (2010)2026

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

Adverse event reports per year · DKZ

2in 2025

2007high 12 (2008) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	1	0
2008	2	—	3	12
2009	2	—	5	1
2010	4	233	0	1
2011	6	123	4	2
2012	5	55	0	0
2013	8	103	1	1
2014	8	128	3	9
2015	5	107	0	8
2016	5	215	0	8
2017	0	—	1	0
2018	3	128	0	0
2019	3	180	0	0
2020	1	—	0	0
2021	0	—	0	3
2022	0	—	0	4
2023	2	—	0	7
2024	1	—	0	1
2025	0	—	0	2
2026	0	—	0	—

What is it indicated for?

Instant-View Amphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect amphetamine in human urine at a cutoff level of 1000 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 results are used.

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

https://510kreport.com/device/K994395 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994395: Instant-View Amphetamine Urine Cassette Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994395

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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