510(k) · Cleared
ClearedHealgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
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 Dec 17, 2024 as substantially equivalent to K240686 (Healgen Scientific,, LLC, 2024) after a 49-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Dec 17, 2024
- Review
- 49 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945610 (1995). 32 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 6 generations between
- 3 generations backK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- 2 generations backK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- 1 generation backK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
- This deviceK243365 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate…Healgen Scientific,, LLC · 2024
Show all 10 generations
- Root · 10 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 9 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 8 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 7 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 6 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 5 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 4 generations backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- 3 generations backK201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA…Assure Tech. (Hangzhou) Co, Ltd. · 2021
- 2 generations backK232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2023
- 1 generation backK240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home…Healgen Scientific,, LLC · 2024
- This deviceK243365 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate…Healgen Scientific,, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −9 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −8 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −7 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −6 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −5 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −4 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| −3 | 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 | — |
| −1 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug… | Healgen Scientific,, LLC | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Summary page 7…ortriptyline (TCA) test system NFW 862.3870, Cannabinoids Test System Toxicology Cannabinoids (THC 50) Predicate Devices: Healgen Accurate Urine Drug Screen Dip Card (K240686) Intended Use The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative dete… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 ancestors have a recall of any class.
- 2 other devices also cite its predicate K240686.
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 Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the…
Read the full statement (387 words)
The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol 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 or 1000
BAR Secobarbital 300
BUP Buprenorphine 10
BZO Oxazepam 300
COC Benzoylecgonine 150 or 300
EDDP 2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrolidine 300
FEN or FYL Norfentanyl 5
MDMA Methylenedioxymethamphetamine 500
MET d-Methamphetamine 500 or 1000
MTD Methadone 300
OPI Morphine 300 or 2000
OXY Oxycodone 100
PCP Phencyclidine 25
PPX d-Propoxyphene 300
TCA Nortriptyline 1000
THC 11-nor-∆9-THC-COOH 50
TRA or TML Tramadol 100
The single or multi-test cups can consist of up to eighteen (18) 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 Multi-Drug Urine Test Cup is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of one or more of the following drugs
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
FYL Norfentanyl 5
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
TML Tramadol 100
6-MAM 6-Monoacetylmorphine 10
This drug test cup may contain any combination of the drug tests listed in the table above.
This test provides only 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.
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/K243365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243365: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243365
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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