510(k) · Cleared
ClearedRapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Innovation Biotech Co., Ltd. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 11, 2014 as substantially equivalent to K122809 (Advin Biotech, 2013) after a 73-day review. Its family tree reaches back 6 generations to 1995. 13 later devices descend from it.
- Decided
- Dec 11, 2014
- Review
- 73 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945610 (1995). 27 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 4 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 3 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 2 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 1 generation backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- This deviceK142800 Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 11 of its ownK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK182530 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK192515 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card…Shenzhen Bioeasy Biotechnology Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK192301 BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK180349 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016 · cites it directly11descendants
- K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2018 · 2 generations on5descendants
- K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…Shenzhen Bioeasy Biotechnology Co., Ltd. · 2019 · 3 generations on1descendant
- K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd. · 2019 · 3 generations on1descendant
- K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −5 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −4 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −3 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −2 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −1 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| 0 (this device) | K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| +1 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016 | — |
| +2 | K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018 | — |
| +3 | K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20… | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019 | — |
| +3 | K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019 | — |
| +2 | K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and CupSummary page 6…JXM,DJR,DJG,LCM 5-1 Co-Innovation Biotech Co.,Ltd. 4. The Predicate Devices K122809 Advin Multi-Drug Screen Test Dip Card Advin Multi-Drug Screen Test Cup Advin Mul… | 2013 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K153050 (Co-Innovation Biotech Co., Ltd., 2016) has gone furthest, with 11 descendants of its own.
- 11 other devices also cite its predicate K122809.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test Calibrator Cut-off level Marijuana (THC) Delta-9-THC-COOH 50ng/mL Cocaine (COC) Benzolecgonine 300ng/mL Amphetamine (AMP) D-Amphetamine 1000ng/mL Methamphetamine (MET) D-Methamphetamine 1000ng/mL…
Read the full statement (217 words)
Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
Test Calibrator Cut-off level
Marijuana (THC) Delta-9-THC-COOH 50ng/mL
Cocaine (COC) Benzolecgonine 300ng/mL
Amphetamine (AMP) D-Amphetamine 1000ng/mL
Methamphetamine (MET) D-Methamphetamine 1000ng/mL
Morphine 2000 (MOP) Morphine 2000ng/mL
Barbiturates (BAR) Secobarbital 300ng/mL
Benzodiazepines (BZO) Oxazepam 300ng/mL
Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500ng/mL
Methadone (MTD) Methadone 300ng/mL
Oxycodone (OXY) Oxycodone 100ng/mL
Phencyclidine (PCP) Phencyclidine 25ng/mL
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.
The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is 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/K142800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142800
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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