# K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Aug 20, 2014 after 148 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- 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: 6 generations back to K945610 (1995). 27 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup, Advin Biotech (2013) Summary page 6.

## Most influential descendants
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (2016), 11 descendants of its own
- K182530: BIOEASY Multi-Drug Test Cup (2018), 5 descendants of its own
- K151348: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) (2015), 2 descendants of its own
- K192515: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (2019), 1 descendant of its own
- K192301: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (2019), 1 descendant of its own

## Indications for use
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test Calibrator Cutoff Level (ng/mL) Buprenorphine (BUP) Buprenorphine 10 2-ethylidene-1, 5-dimethyl-3, 2-ethylidene-1, 5-dimethyl-3, 300 3-diphenylpyrrolidine (EDDP) 3-diphenylpyrrolidine Morphine (MOP300) Morphine 300 Propoxyphene (PPX) Propoxyphene 300 Tricyclic Antidepressants (TCA) Nortriptyline 1000 There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use. The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, Propoxyphene, or Tricyclic Antidepressants are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine, Propoxyphene, or Tricyclic Antidepressants in urine. This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) or an equivalent analytical method is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K140748
Methodology: https://510kreport.com/methodology