510(k) · Cleared
ClearedHealgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · NGL Test, Opiates, Over The Counter
Cleared on Apr 12, 2024 as substantially equivalent to K232659 (Guangzhou Decheng Biotechnology Co., Ltd., 2023) after a 31-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 12, 2024
- Review
- 31 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945610 (1995). 31 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations between
- 3 generations backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- 2 generations backK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- 1 generation backK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- This deviceK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
- Descendant · cites it directly · 0 of its ownK253567 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2025
- Descendant · cites it directly · 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 ownK243365 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate…Healgen Scientific,, LLC · 2024
Show all 9 generations
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 8 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 7 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 6 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 5 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 4 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 3 generations backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- 2 generations backK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- 1 generation backK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- This deviceK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC · 2025 · cites it directly0descendants
- K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd. · 2025 · cites it directly0descendants
- K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…Healgen Scientific,, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −8 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −7 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −6 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −5 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −4 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −3 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2024 | — |
| +1 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2025 | — |
| +1 | K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | 2025 | — |
| +1 | 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 | 1 | 0 |
| 2025 | 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 NGL? 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 NGL device
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 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 |
|---|---|---|---|
| * | K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupSummary page 6…862.3870, Cannabinoids Test System Toxicology Cannabinoids (THC 50) 6. Predicate Devices: Dochek® Multi-Drug Urine Test Cup (K232659) 7. Intended Use The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualit… | 2023 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip… | 2025 | 0 |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 0 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine… | 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 29 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K253567 (Healgen Scientific,, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K232659.
How does its category compare?
All NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, 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…
Read the full statement (380 words)
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, 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:
Test Calibrator Cut-off (ng/mL)
6-MAM 6-Monoacetylmorphine 10
AMP d-Amphetamine 500 / 1000
BAR Secobarbital 300
BUP Buprenorphine 10
BZO Oxazepam 300
COC Benzoylecgonine 150 / 300
EDDP 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine 300
MDMA Methylenedioxymethamphetamine 500
MET d-Methamphetamine 500 / 1000
MTD d/l-Methadone 300
OPI Morphine 300 / 2000
OXY Oxycodone 100
PCP Phencyclidine 25
PPX d-Propoxyphene 300
TCA Nortriptyline 1000
THC 11-nor-∆⁹-THC-COOH 50
The single or multi-test panels can consist of up to sixteen (16) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. 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.
The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.
This is not a screening device to monitor prescription medication.
CODE SUBSTANCE CUT-OFF (ng/mL)
AMP Amphetamine 1000 or 500
BUP Buprenorphine 10
BAR Secobarbital 300
BZO Oxazepam 300
COC Cocaine 300 or 150
EDDP EDDP 300
MET/mAMP Methamphetamine 1000 or 500
MDMA Ecstasy 500
OPI Morphine 2000 or 300
MTD Methadone 300
OXY Oxycodone 100
PCP Phencyclidine 25
PPX Propoxyphene 300
TCA Nortriptyline 1000
THC Marijuana 50
6-MAM 6-Monoacetylmorphine 10
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.
This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240686
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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