510(k) · Cleared
ClearedDochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Decheng Biotechnology Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Dec 13, 2023 as substantially equivalent to K201630 (Assure Tech. (Hangzhou) Co, Ltd., 2021) after a 104-day review. Its family tree reaches back 8 generations to 1995. 6 later devices descend from it.
- Decided
- Dec 13, 2023
- Review
- 104 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945610 (1995). 30 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 7 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 6 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 5 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 4 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 3 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 2 generations backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- 1 generation backK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- This deviceK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK253567 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK250803 Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine…Anhui Deepblue Medical Technological Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250067 Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup…Guangzhou Decheng Biotechnology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243365 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate…Healgen Scientific,, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2024 · cites it directly3descendants
- K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2025 · 2 generations on0descendants
- K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd. · 2025 · 2 generations on0descendants
- K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd. · 2025 · cites it directly0descendants
- K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…Healgen Scientific,, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −7 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −6 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −5 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −4 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −3 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −2 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| −1 | K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2021 | — |
| 0 (this device) | K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023 | — |
| +1 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2024 | — |
| +2 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2025 | — |
| +2 | K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | 2025 | — |
| +1 | K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | — |
| +2 | K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home… | Healgen Scientific,, LLC | 2024 | — |
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 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 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 DJG? 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 DJG device
- #1 K240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™…score 15.0 · 6 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 |
|---|---|---|---|
| * | K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsSummary page 8…Toxicology 6-Monoacetylmorphine(6-MAM) 6. Predicate Devices: AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests(K201630) 7. Intended Use Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple… | 2021 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip… | 2024 | 3 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | 2025 | 0 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | 2024 | 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 28 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K240686 (Healgen Scientific,, LLC, 2024) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K201630.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Drug (Identifier) — Cut-off level (ng/mL) Amphetamine (AMP) — 1000 or 500 Secobarbital (BAR) — 300 Buprenorphine (BUP) — 10 Oxazepam (BZO) — 300 Cocaine (COC) — 300 or 150 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 Methylenedioxymethamphetamine (MDMA) — 500…
Read the full statement (393 words)
Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
Drug (Identifier) — Cut-off level (ng/mL)
Amphetamine (AMP) — 1000 or 500
Secobarbital (BAR) — 300
Buprenorphine (BUP) — 10
Oxazepam (BZO) — 300
Cocaine (COC) — 300 or 150
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300
Methylenedioxymethamphetamine (MDMA) — 500
Methamphetamine (MET) — 1000 or 500
Morphine (MOP300/OPI2000) — 2000 or 300
Methadone (MTD) — 300
Oxycodone (OXY) — 100
Phencyclidine (PCP) — 25
Propoxyphene (PPX) — 300
Nortriptyline (TCA) — 1000
Cannabinoids (THC) — 50
6-Monoacetylmorphine (6-MAM) — 10
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
Drug (Identifier) — Cut-off level (ng/mL)
Amphetamine (AMP) — 1000 or 500
Secobarbital (BAR) — 300
Buprenorphine (BUP) — 10
Oxazepam (BZO) — 300
Cocaine (COC) — 300 or 150
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300
Methylenedioxymethamphetamine (MDMA) — 500
Methamphetamine (MET) — 1000 or 500
Morphine (MOP300/OPI2000) — 2000 or 300
Methadone (MTD) — 300
Oxycodone (OXY) — 100
Phencyclidine (PCP) — 25
Propoxyphene (PPX) — 300
Nortriptyline (TCA) — 1000
Cannabinoids (THC) — 50
6-Monoacetylmorphine (6-MAM) — 10
Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .
It is intended for prescription use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
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/K232659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232659: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232659
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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