# K260065: SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Apr 28, 2026 after 109 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: 8 generations back to K945610 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx, Guangzhou Wondfo Biotech Co., Ltd. (2020) Summary page 7.

## Indications for use
SAFElife™ T-Dip Multi-Drug Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of: Drug (Identifier) Cutoff Level 6-Monoacetylmorphine(6-MAM) 10 ng/mL Amphetamine (AMP) 1000 ng/mL or 500 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 ng/mL or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Fentanyl (FTY) 1 ng/mL Methamphetamine (MET/mAMP) 1000 ng/mL or 500 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP)) 300 ng/mL Opiates (OPI) 2000 ng/mL Methadone (MTD) 300 ng/mL Norfentanyl (NFTY) 5 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Cannabinoids (THC) 50 ng/mL or 20 ng/mL Tramadol (TRA) 100 ng/mL SAFElife™ T-Dip Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests listed above but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use. The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method. SAFElife™ T-Dip Multi-Drug Urine Test Panel Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff concentrations: Drug (Identifier) Calibrator Cut-off Level 6-Monoacetylmorphine (6-MAM) 6-Monoacetylmorphine 10 ng/mL Amphetamine (AMP500) d-Amphetamine 500 ng/mL Amphetamine (AMP1000) d-Amphetamine 1000 ng/mL Secobarbital (BAR) Secobarbital 300 ng/mL Buprenorphine (BUP) Buprenorphine 10 ng/mL Oxazepam (BZO) Oxazepam 300 ng/mL Cocaine (COC150) Benzoylecgonine 150 ng/mL Cocaine (COC300) Benzoylecgonine 300 ng/mL 2-ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) 2-ethylidene-1,5-dimethyl-3, 3-diphenyl-pyrrolidine 300 ng/mL Fentanyl (FTY) Fentanyl 1 ng/mL Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500 ng/mL Methamphetamine (MET500/mAMP500) D(+)-Methamphetamine 500 ng/mL Methamphetamine (MET1000/mAMP1000) D(+)-Methamphetamine 1000 ng/mL Morphine (MOP300) Morphine 300 ng/mL Opiates (OPI2000) Morphine 2000 ng/mL Methadone (MTD) Methadone 300 ng/mL Norfentanyl (NFTY) Norfentanyl 5 ng/mL Oxycodone (OXY) Oxycodone 100 ng/mL Phencyclidine (PCP) Phencyclidine 25 ng/mL Propoxyphene (PPX) d-Propoxyphene 300 ng/mL Nortriptyline (TCA) Nortriptyline 1000 ng/mL Cannabinoids (THC20) 11-nor- 9-THC-9-COOH 20 ng/mL Cannabinoids (THC50) 11-nor- 9-THC-9-COOH 50 ng/mL Tramadol (TRA) Tramadol 100 ng/mL SAFElife™ T-Dip Multi-Drug Urine Test Panel Dx offers any combinations from 1 to 15 drugs of abuse tests listed above with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use. The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

Source page: https://510kreport.com/device/K260065
Methodology: https://510kreport.com/methodology