# K180349: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech. (Hangzhou) Co, Ltd.
- Decided: Apr 5, 2018 after 56 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). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard, Co-Innovation Biotech Co., Ltd. (2016) Summary page 6.

## Most influential descendants
- K190412: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (2019), 0 descendants of its own

## Indications for use
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, 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 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Marijuana 50 ng/mL Methamphetamine 1000 ng/mL Morphine 300 ng/mL or 2000 ng/mL Oxycodone 100 ng/mL Secobarbital 300 ng/mL Buprenorphine 10 ng/mL Methylenedioxy-methamphetamine 500 ng/mL Phencyclidine 25 ng/mL Methadone 300 ng/mL EDDP 300 ng/mL Nortriptyline 1000 ng/mL d-Propoxyphene 300 ng/mL Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone 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 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.

Source page: https://510kreport.com/device/K180349
Methodology: https://510kreport.com/methodology