510(k) · Cleared
ClearedScreeners Opiates Test Drugscreen Dip Opiates Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drug Detection Devices, Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Apr 7, 2000 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 7, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK000273 Screeners Opiates Test Drugscreen Dip Opiates TestDrug Detection Devices, Ltd. · 2000
- Descendant · cites it directly · 4 of its ownK013380 Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceACON Laboratories, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK041685 Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK122752 Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen…Branan Medical Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK080467 Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels (…Applied Dna Technologies, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK041743 Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K013380Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceACON Laboratories, Inc. · 2001 · cites it directly4descendants
- K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc. · 2004 · 2 generations on1descendant
- K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…Branan Medical Corp. · 2013 · 3 generations on0descendants
- K080467Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc…Applied Dna Technologies, Inc. · 2008 · 2 generations on0descendants
- K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000273 | Screeners Opiates Test Drugscreen Dip Opiates Test | Drug Detection Devices, Ltd. | 2000 | — |
| +1 | K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device | ACON Laboratories, Inc. | 2001 | — |
| +2 | K041685 | Acon Multi-Clin Drug Screen Test Device | ACON Laboratories, Inc. | 2004 | — |
| +3 | K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox… | Branan Medical Corp. | 2013 | — |
| +2 | K080467 | Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar… | Applied Dna Technologies, Inc. | 2008 | — |
| +2 | K041743 | Acon Tri-Fect Drug Screen Test Device | ACON Laboratories, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device | 2001 | 4 |
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, K013380 (ACON Laboratories, Inc., 2001) has gone furthest, with 4 descendants 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 | — |
https://510kreport.com/device/K000273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000273: Screeners Opiates Test Drugscreen Dip Opiates Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000273
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026