510(k) Report

510(k) · Cleared

Cleared

Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device

K033047510(k) TraditionalCleared Feb 17, 2004141-day reviewClass II21 CFR 862.3650

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

ACON Laboratories, Inc. · DJG Enzyme Immunoassay, Opiates

Cleared on Feb 17, 2004 after a 141-day review. The FDA summary names no predicate by number. 23 later devices descend from it.

Decided
Feb 17, 2004
Review
141 days
Class
Class II
Product code
DJG
Recalls
None
Predicates
0

23 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2010: 2 descendants cleared2007: 1 descendant cleared2012: 1 descendant cleared2013: 3 descendants cleared2016: 1 descendant cleared2018: 3 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK033047 Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step…ACON Laboratories, Inc. · 2004
  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 23 descendants. See all descendants

Descendants cleared per year

2004: 22007: 12010: 22012: 12013: 32016: 12018: 32019: 12023: 12024: 22025: 42026: 2
2004high 4 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 23 · 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)K033047Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test…ACON Laboratories, Inc.2004—
+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
200420
200710
201020
201210
201330
201610
201830
201910
202310
202420
202540
202620
FIG. 1 — Lineage of K033047, 2004–2026Source: 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 DJG? 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 DJG device

  1. #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 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?

The FDA summary names no predicate by number.

What descends from it? (23)

See all 23

5 later devices cite 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
K113624Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine TestGuangzhou Wondfo Biotech Co., Ltd.20121
K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc.20041
K093175Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test…Guangzhou Wondfo Biotech Co., Ltd.20100
K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc.20040

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 DJG devices

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

FDA decisions per year · DJG

3in 2025

2007: 22008: 22009: 22010: 62011: 62012: 52013: 52014: 92015: 122016: 22017: 42018: 52019: 32020: 52021: 32022: 22023: 102024: 52025: 32026 (partial year): 3
2007high 12 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJG

31in 2025

2010: 187 days median2011: 233 days median2012: 95 days median2013: 60 days median2014: 62 days median2015: 141 days median2017: 101 days median2018: 134 days median2019: 235 days median2020: 30 days median2021: 422 days median2023: 140 days median2024: 150 days median2025: 31 days median2026 (partial year): 157 days median
2007high 422 (2021) · low 30 (2020)2026

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

Recalls per year · DJG

2in 2025

2011: 12019: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · DJG

1in 2025

2011: 42012: 12013: 42015: 32016: 22017: 12018: 12021: 22022: 12024: 32025: 1
2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJG, 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
20072—00
20082—00
20092—00
2010618700
2011623314
201259501
201356004
201496200
20151214103
20162—02
2017410101
2018513401
2019323510
202053000
2021342202
20222—01
20231014000
2024515003
202533121
202631570—

What is it indicated for?

The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone levels in urine at a designated cutoff concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

Indications for use as stated in the FDA summary.

More from ACON Laboratories, Inc.

86 FDA decisions under this applicant name. See the company

  • K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc. · 2026
  • K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc. · 2025
  • K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. · 2025
  • K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone…ACON Laboratories, Inc. · 2025
  • K250377Flowflex Plus COVID-19 + Flu A/B Home TestACON Laboratories, Inc. · 2025

Recent decisions in DJG

The DJG category page

  • K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
  • K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
  • K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026
  • K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
  • K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen®…Healgen Scientific,, LLC · 2025

https://510kreport.com/device/K033047 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033047: Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033047

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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