510(k) · Cleared
ClearedATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advin Biotech, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Mar 29, 2019 as substantially equivalent to K122809 (Advin Biotech, 2013) after a 235-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Mar 29, 2019
- Review
- 235 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945610 (1995). 27 ancestors in all. 11 later devices descend from it, 3 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 deviceK182123 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. · 2019
- Descendant · cites it directly · 8 of its ownK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- Descendant · 2 generations on · 6 of its ownK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- Descendant · 3 generations on · 3 of its ownK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK253567 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK250803 Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine…Anhui Deepblue Medical Technological Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2021 · cites it directly8descendants
- K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd. · 2023 · 2 generations on6descendants
- K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2024 · 3 generations on3descendants
- K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2025 · 4 generations on0descendants
- K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd. · 2025 · 4 generations on0descendants
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) | K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | 2019 | — |
| +1 | K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2021 | — |
| +2 | K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | 2023 | — |
| +3 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2024 | — |
| +4 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2025 | — |
| +4 | K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 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? (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 5…23 B. Purpose for Submission: a. Addition of Amphetamine 1000, Cocaine 300, Methamphetamine 1000 and 6- Acetylmorphine 10 to a previously cleared device (k122809) b. Update formulation of Opiate 300 assay from the same previously cleared device C. Measurand: 6-Acetylmorphine,… | 2013 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | 2021 | 8 |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit… | 2024 | 0 |
| K232597 | LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette)… | 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 24 years and passes through 6 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K201630 (Assure Tech. (Hangzhou) Co, Ltd., 2021) has gone furthest, with 8 descendants of its own.
- 11 other devices also cite its predicate K122809.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d- Methamphetamine, d/lMethylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are…
Read the full statement (254 words)
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the
qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-
Methamphetamine, d/lMethylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone,
Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the
compounds the tests are calibrated to are as follows:
Analyte Calibrator Cutoff (ng/mL)
6-Acetylmorphine 6-monoacetylmorphine 10
Amphetamine d-Amphetamine 500
Amphetamine d-Amphetamine 1,000
Barbiturates Secobarbital/Pentobarbital 300
Benzodiazepines Oxazepam 300
Buprenorphine Buprenorphine 10
EDDP 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine 300
Cocaine Benzoylecgonine 150
Cocaine Benzoylecgonine 300
Ecstasy d,l-Methylenedioxymethamphetamine 500
Methamphetamine d-Methamphetamine 500
Methamphetamine d-Methamphetamine 1,000
Marijuana 11-nor-Δ9-THC-9-COOH 50
Methadone d/l-Methadone 300
Opiates Morphine 300
Opiates Morphine 2,000
Oxycodone Oxycodone 100
Phencyclidine Phencyclidine 25
Propoxyphene Propoxyphene 300
Tricyclic Antidepressants Nortriptyline 1,000
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16
analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format and in the cup
format. The drug screen tests are intended for prescription use only.
The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain
a confirmed presumptive positive result if the donor doesn’t admit use or anytime required by testing procedures. Gas
Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem
mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be
applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
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/K182123 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182123: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182123
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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