# K243365: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Dec 17, 2024 after 49 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K945610 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card, Healgen Scientific,, LLC (2024) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K243365
Methodology: https://510kreport.com/methodology