510(k) · Cleared
ClearedBionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mk Bio, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Aug 20, 2009 as substantially equivalent to K061005 (Applied Dna Technologies, Inc., 2006) after a 318-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 20, 2009
- Review
- 318 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945610 (1995). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 3 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 2 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 1 generation backK061005 Accustep Doa Single and Multi-Strip Screen PanelsApplied Dna Technologies, Inc. · 2006
- This deviceK082977 Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated CupMk Bio, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −3 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −2 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −1 | K061005 | Accustep Doa Single and Multi-Strip Screen Panels | Applied Dna Technologies, Inc. | 2006 | — |
| 0 (this device) | K082977 | Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup | Mk Bio, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K061005 | Accustep Doa Single and Multi-Strip Screen PanelsSummary page 3…e indicated. Description: Bionexia OptiCup is derived from a previously FDA-cleared device, ADT's ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels (K061005). The unmodified test is made of various number of single drug-of-abuse (DOA) test strips (from 1 to 10 strips) placed in an ope… | 2006 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 19 ancestors has a recall.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Bionexia OptiCup is a rapid chromatographic immuneassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine at or above the following concentrations: Marijuana 50 ng/mL Cocaine 300 ng/mL Phencyclidine 25 ng/mL Morphine 2,000 ng/mL Methamphetamine 1,000 ng/mL Methadone 300 ng/mL…
Read the full statement (92 words)
The Bionexia OptiCup is a rapid chromatographic immuneassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine at or above the following concentrations:
Marijuana 50 ng/mL
Cocaine 300 ng/mL
Phencyclidine 25 ng/mL
Morphine 2,000 ng/mL
Methamphetamine 1,000 ng/mL
Methadone 300 ng/mL
Amphetamine 1,000 ng/mL
Barbiturates 300 ng/mL
Benzodiazepines 300 ng/mL
Nortriptyline 1,000 ng/mL
The test strips with an integrated cup is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082977: Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082977
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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