# K243996: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup - Pathway: 510(k) (Traditional) - Applicant: Assure Tech., LLC - Decided: Feb 7, 2025 after 43 days - Product code: NFT (Test, Amphetamine, Over The Counter) - Device class: 2 - Regulation: 21 CFR 862.3100 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K945610 (1995). 28 ancestors in all. 2 later devices descend from it; 1 cites it directly. 0 of 31 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, Assure Tech. (Hangzhou) Co, Ltd. (2018) Summary page 8. ## Most influential descendants - K252259: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (2025), 1 descendant of its own - K261984: AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (2026), 0 descendants of its own ## Indications for use The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Norfentanyl, 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 Amphetamine (AMP) 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL Methadone metabolite (EDDP) 300ng/ml Fentanyl (FYL) 1 ng/mL Ecstasy (MDMA) 500 ng/mL Methamphetamine (MET) 500 ng/mL Morphine (MOR) 300 ng/mL Methadone (MTD) 300 ng/mL Norfentanyl (NFYL) 5 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. 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. The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Norfentanyl, 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 Amphetamine (AMP) 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL Methadone metabolite (EDDP) 300ng/ml Fentanyl (FYL) 1 ng/mL Ecstasy (MDMA) 500 ng/mL Methamphetamine (MET) 500 ng/mL Morphine (MOR) 300 ng/mL Methadone (MTD) 300 ng/mL Norfentanyl (NFYL) 5 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. 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. The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL Methadone metabolite (EDDP) 300ng/ml Fentanyl (FYL) 1 ng/mL Ecstasy (MDMA) 500 ng/mL Methamphetamine (MET) 500 ng/mL Morphine (MOR) 300 ng/mL Methadone (MTD) 300 ng/mL Norfentanyl (NFYL) 5 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL Methadone metabolite (EDDP) 300ng/ml Fentanyl (FYL) 1 ng/mL Ecstasy (MDMA) 500 ng/mL Methamphetamine (MET) 500 ng/mL Morphine (MOR) 300 ng/mL Methadone (MTD) 300 ng/mL Norfentanyl (NFYL) 5 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Source page: https://510kreport.com/device/K243996 Methodology: https://510kreport.com/methodology