510(k) · Cleared
ClearedAcon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Dec 18, 2001 as substantially equivalent to K000273 (Drug Detection Devices, Ltd., 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Dec 18, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000273 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000273 Screeners Opiates Test Drugscreen Dip Opiates TestDrug Detection Devices, Ltd. · 2000
- This deviceK013380 Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceACON Laboratories, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK041685 Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK122752 Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen…Branan Medical Corp. · 2013
- Descendant · cites it directly · 0 of its ownK080467 Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels (…Applied Dna Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK041743 Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc. · 2004 · cites it directly1descendant
- K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…Branan Medical Corp. · 2013 · 2 generations on0descendants
- K080467Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc…Applied Dna Technologies, Inc. · 2008 · cites it directly0descendants
- K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000273 | Screeners Opiates Test Drugscreen Dip Opiates Test | Drug Detection Devices, Ltd. | 2000 | — |
| 0 (this device) | K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device | ACON Laboratories, Inc. | 2001 | — |
| +1 | K041685 | Acon Multi-Clin Drug Screen Test Device | ACON Laboratories, Inc. | 2004 | — |
| +2 | K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox… | Branan Medical Corp. | 2013 | — |
| +1 | K080467 | Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar… | Applied Dna Technologies, Inc. | 2008 | — |
| +1 | K041743 | Acon Tri-Fect Drug Screen Test Device | ACON Laboratories, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
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 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000273 | Screeners Opiates Test Drugscreen Dip Opiates TestSummary page 2…ting that proper volume of specimen has been added and membrane wicking has occurred. Predicate Device: Screener Opiate Test Drugscreen™ DIP Opiate Test 510(k) Number: K000273 Comparison to a Predicate Device: A comparison of the features of the ACON MOP One Step Opiate Test Strip and ACON MOP One Step… | 2000 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K041685 (ACON Laboratories, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiate in human urine at a cut-off concentration of 300 ng/mL. They are intended for healthcare professional use.
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/K013380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013380: Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate 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/K013380
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026