510(k) · Cleared
ClearedBIOEASY Multi-Drug Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Bioeasy Biotechnology Co., Ltd. · NGL Test, Opiates, Over The Counter
Cleared on Jan 31, 2020 as substantially equivalent to K182530 (Shenzhen Bioeasy Biotechnology Co., Ltd., 2018) after a 46-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jan 31, 2020
- Review
- 46 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945610 (1995). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations between
- 3 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 2 generations backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- 1 generation backK182530 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2018
- This deviceK193480 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 8 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 7 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 6 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 5 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 4 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 3 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 2 generations backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- 1 generation backK182530 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2018
- This deviceK193480 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −8 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −7 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −6 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −5 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −4 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −3 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| −2 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016 | — |
| −1 | K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018 | — |
| 0 (this device) | K193480 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2020 | — |
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 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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 NGL? 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 NGL device
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 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 |
|---|---|---|---|
| * | K182530 | BIOEASY Multi-Drug Test CupSummary page 5…II 21 CFR, 862.3700 Propoxyphene Toxicology (91) Propoxyphene Test System 5. Predicate Devices: K182530 3 The Shenzhen B… | 2018 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 31 ancestors have a recall of any class.
- 2 other devices also cite its predicate K182530.
How does its category compare?
All NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam…
Read the full statement (206 words)
BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
Drug(Identifier) Cut-off level
Amphetamine 1000 ng/mL
Oxazepam 300 ng/mL
Cocaine 300 ng/mL
Marijuana 50 ng/mL
Methamphetamine 1000 ng/mL
Morphine 300 ng/mL or 2000 ng/mL
Oxycodone 100 ng/mL
Secobarbital 300 ng/mL
Buprenorphine 10 ng/mL
Methylenedioxy-methamphetamine 500 ng/mL
Phencyclidine 25 ng/mL
Methadone 300 ng/mL
Nortriptyline 1000 ng/mL
d-Propoxyphene 300 ng/mL
Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193480: BIOEASY Multi-Drug Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193480
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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