510(k) · Cleared
ClearedAdvin Multi-Drug Screen Test Cassette, Dip Card and Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advin Biotech · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jun 17, 2013 as substantially equivalent to K061718 (Innovacon, Inc., 2006) after a 277-day review. Its family tree reaches back 5 generations to 1995. 55 later devices descend from it.
- Decided
- Jun 17, 2013
- Review
- 277 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945610 (1995). 26 ancestors in all. 55 later devices descend from it, 12 citing it directly.
- Root · 5 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 4 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 3 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 2 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 1 generation backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- This deviceK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- Descendant · cites it directly · 16 of its ownK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 13 of its ownK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- Descendant · cites it directly · 13 of its ownK142800 Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 12 of its ownK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- Descendant · cites it directly · 11 of its ownK182123 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. · 2019
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · cites it directly16descendants
- K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · cites it directly13descendants
- K142800Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · cites it directly13descendants
- K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018 · cites it directly12descendants
- K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. · 2019 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −4 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −3 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −2 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −1 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| 0 (this device) | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| +1 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| +1 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
| +1 | K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| +1 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| +1 | K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 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 |
|---|---|---|---|
| * | K061718 | Innovacon Spectrum II Test CardSummary page 4…ic gravity, pH, glutaraldehyde, creatinine and nitrite. : Predicate Devices and 510(k) Numbers: Innovacon Spectrum Il Test Card and Test Card with Integrated Test Cup (K061718) Comparison to a Predicate Device: The ADVIN Multi-Drug Screen Test (Cassette, Dipcard and Cup) have following similarities com… | 2006 |
What descends from it? (55)
See all 5512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | 2014 | 16 |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | 2018 | 13 |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | 2014 | 13 |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | 2018 | 12 |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | 2019 | 11 |
| K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip… | 2015 | 1 |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | 2023 | 0 |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | 2020 | 0 |
| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of… | 2018 | 0 |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC… | 2016 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K140748 (Co-Innovation Biotech Co., Ltd., 2014) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K061718.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels: Drug Test — Calibrator — Cutoff Level Amphetamine (AMP) — d-Amphetamine — 500 ng/mL Barbiturates (BAR) — Secobarbital — 300 ng/mL Benzodiazepines (BZO) — Oxazepam — 300 ng/mL Buprenorphine (BUP) — Buprenorphine — 10 ng/mL Cocaine (COC) — Benzoylecgnine — 150 ng/mL EDDP…
Read the full statement (342 words)
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels:
Drug Test — Calibrator — Cutoff Level
Amphetamine (AMP) — d-Amphetamine — 500 ng/mL
Barbiturates (BAR) — Secobarbital — 300 ng/mL
Benzodiazepines (BZO) — Oxazepam — 300 ng/mL
Buprenorphine (BUP) — Buprenorphine — 10 ng/mL
Cocaine (COC) — Benzoylecgnine — 150 ng/mL
EDDP — 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine — 300 ng/mL
Ecstasy (MDMA) — Methylenedioxymethamphetamine — 500 ng/mL
Methamphetamine (MET) — d-Methamphetamine — 500 ng/mL
Methadone (MTD) — Methadone — 300 ng/mL
Morphine (MOR300) — Morphine — 300 ng/mL
Opiates (OPI) — Morphine — 2,000 ng/mL
Oxycodone (OXY) — Oxycodone — 100 ng/mL
Phencyclidine (PCP) — Phencyclidine — 25 ng/mL
Propoxyphene (PPX) — Propoxyphene — 300 ng/mL
Tricyclic-antidepressant (TCA) — Nortriptynine — 1,000 ng/mL
Marijuana (THC) — 1-nor-A9-THC-9-COOH — 50 ng/mL
The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table.
Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use.
The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine.
The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.
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/K122809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122809
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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