510(k) · Cleared

Cleared

Instant-View Propoxyphene (PPX) Urine Test

K022915510(k) TraditionalCleared Nov 29, 200287-day reviewClass II21 CFR 862.3700

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. · JXN Enzyme Immunoassay, Propoxyphene

Cleared on Nov 29, 2002 after an 87-day review. The FDA summary names no predicate by number. 20 later devices descend from it.

Decided: Nov 29, 2002
Review: 87 days
Class: Class II
Product code: JXN
Recalls: None
Predicates: 0

20 later devices descend from it, 2 citing it directly.

This deviceK022915 Instant-View Propoxyphene (PPX) Urine TestAlfa Scientific Designs, Inc. · 2002
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 20 descendants. See all descendants

Descendants cleared per year

2006high 4 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 20 · 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
0 (this device)	K022915	Instant-View Propoxyphene (PPX) Urine Test	Alfa Scientific Designs, Inc.	2002	—
+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
2006	2	0
2007	1	0
2008	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 K022915, 2002–2026Source: 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 JXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (20)

See all 20

2 later devices cite 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
K052882	Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device	Tianjin New Bay Bioresearch Co., Ltd.	2006	2

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 JXN devices

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

FDA decisions per year · JXN

1in 2015

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXN

Too few JXN 510(k)s in any year since 2007 to give a median.

Recalls per year · JXN

1in 2010

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JXN

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code JXN, 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	—	0	0
2008	0	—	1	0
2009	0	—	0	0
2010	0	—	1	0
2011	1	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	0	—	0	0
2015	1	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Instant-View™ Propoxyphene (PPX) Urine Test is a rapid one-step immunoassay intended for use in the qualitative detection of propoxyphene in human urine at a cutoff concentration of 300 ng/ml. It is 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 Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022915 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022915: Instant-View Propoxyphene (PPX) Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022915

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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