510(k) · Cleared
ClearedAssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assure Tech. (Hangzhou) Co, Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Aug 12, 2021 as substantially equivalent to K181768 (Assure Tech. (Hangzhou) Co, Ltd., 2018) and 1 other predicate after a 422-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- Aug 12, 2021
- Review
- 422 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945610 (1995). 29 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 6 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 5 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 4 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 3 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 2 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 1 generation backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- This deviceK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- Descendant · cites it directly · 6 of its ownK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK253567 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2025
- Descendant · 3 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 · 2 generations on · 0 of its ownK250067 Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup…Guangzhou Decheng Biotechnology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd. · 2023 · cites it directly6descendants
- K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2024 · 2 generations on3descendants
- K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2025 · 3 generations on0descendants
- K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd. · 2025 · 3 generations on0descendants
- K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −6 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −5 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −4 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −3 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −2 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −1 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| 0 (this device) | K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2021 | — |
| +1 | K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023 | — |
| +2 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2024 | — |
| +3 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2025 | — |
| +3 | K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | 2025 | — |
| +2 | K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2023 | 2 | 0 |
| 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 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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? (2)
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 |
|---|---|---|---|
| * | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup TestsSummary page 6…II 21 CFR, 862.3700 Propoxyphene Toxicology (91) Propoxyphene Test System 5. Predicate Devices: K181768 & K182123 AssureTech Panel Dip Tests and AssureTech Quick Cup Tests (K181768) Advin Biotech ATTEST Drug Screen Cup and AT… | 2018 |
| * | K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardSummary page 6…II 21 CFR, 862.3700 Propoxyphene Toxicology (91) Propoxyphene Test System 5. Predicate Devices: K181768 & K182123 AssureTech Panel Dip Tests and AssureTech Quick Cup Tests (K181768) Advin Biotech ATTEST Drug Screen Cup and ATTEST Drug… | 2019 |
What descends from it? (8)
2 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 26 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K232659 (Guangzhou Decheng Biotechnology Co., Ltd., 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K181768.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: Drug(Identifier) —…
Read the full statement (458 words)
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
Drug(Identifier) — Cut-off level
6-Monoacetylmorphine — 10 ng/mL
Amphetamine — 500 ng/mL
Oxazepam — 300 ng/mL
Cocaine — 150 ng/mL
Marijuana — 20 ng/mL
Methamphetamine — 500 ng/mL
Morphine — 300 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
EDDP — 300 ng/mL
Nortriptyline — 1000 ng/mL
d-Propoxyphene — 300 ng/mL
Configuration of the AssureTech DOA Dipstick Screen Panel 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.
AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
Drug(Identifier) — Cut-off level
6-Monoacetylmorphine — 10 ng/mL
Amphetamine — 500 ng/mL
Oxazepam — 300 ng/mL
Cocaine — 150 ng/mL
Marijuana — 20 ng/mL
Methamphetamine — 500 ng/mL
Morphine — 300 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
EDDP — 300 ng/mL
Nortriptyline — 1000 ng/mL
d-Propoxyphene — 300 ng/mL
Configuration of the AssureTech DOA Integrated 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/K201630 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201630: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201630
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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