510(k) · Cleared
ClearedBionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Dna Technologies, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Nov 25, 2008 as substantially equivalent to K022589 (ACON Laboratories, Inc., 2002) and 1 other predicate after a 278-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 25, 2008
- Review
- 278 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000273 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK000273 Screeners Opiates Test Drugscreen Dip Opiates TestDrug Detection Devices, Ltd. · 2000
- 1 generation backK013380 Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceACON Laboratories, Inc. · 2001
- This deviceK080467 Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels (…Applied Dna Technologies, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K080467 | Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar… | Applied Dna Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test DeviceSummary page 2…ance with the GC/MS confirmed clinical urine specimens. 510(k) numbers for predicate devices are: ACON One Step Ecstasy Screen Test K 022589 ACON One Step Morphine 300 Test K 013380 Performance: The product performance characteris… | 2002 |
| * | K013380 | Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test DeviceSummary page 2…icate devices are: ACON One Step Ecstasy Screen Test K 022589 ACON One Step Morphine 300 Test K 013380 Performance: The product performance characteristics of ADT's Bionexia TM DOA Screen Panels were evaluated in the blind-labeled… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K022589.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Applied DNA Technologies BionexiaTM DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: Analyte — Abbreviation — Calibrator — Cutoff Concentration Amphetamine — AMP — Amphetamine — 1000 ng/mi Barbiturate — BAR — Secobarbital — 300…
Read the full statement (255 words)
The Applied DNA Technologies BionexiaTM DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
Analyte — Abbreviation — Calibrator — Cutoff Concentration
Amphetamine — AMP — Amphetamine — 1000 ng/mi
Barbiturate — BAR — Secobarbital — 300 ng/ml
Benzodiazepines — BZO — Oxazepam — 300 ng/mi
Cocaine — COC — Benzoylecgonine — 300 ng/ml
Marijuana — THC — 11-nor-A9 -THC9-COOH — 50 ng/ml
Methamphetamine — MET — Methamphetamine — 1000 ng/mi
Methadone — MTD — Methadone — 300 ng/ml
Morphine — MOR — Morphine — 2000 ng/ml
Morphine — MOR — Morphine — 300 ng/ml
Phencyclidine — PCP — Phencyclidine — 25 ng/mi
Nortriptyline — NOR — Nortriptyline — 1000 ng/ml
Ecstasy — MDMA — 3,4-Methylenediioxy-MET — 500 ng/ml
Buprenorphine — BUP — BUP-3-D-Glucuronide — 10 ng/ml
EDDP — EDDP — 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine — 100 ng/mi
For health care professionals use including professionals at point of care sites (POC) to assist in the determination of drug compliance.
This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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 indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080467 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080467: Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080467
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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