# K140089: CR3 Keyless Split Sample Cup (Opi-Bzo)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Apr 8, 2014 after 84 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: 3 generations back to K020771 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130665: Wondofo Multi-Drug Urine Test Cup / Panel, Guangzhou Wondfo Biotech Co., Ltd. (2013) Summary page 1.

## Most influential descendants
- K151478: Wondfo CR3 Keyless Split Sample Cup (2015), 0 descendants of its own

## Indications for use
CR3 Keyless Split Sample Cup Morphine-Oxazepam is a rapid test for the qualitative detection of Morphine (a drug in the opiate class) and Oxazepam (a drug in the benzodiazepine class) in human urine at a cutoff concentration of 2000ng/mL and 300ng/mL, respectively. The tests may yield preliminary positive results even when prescription drugs including Morphine and Oxazepam 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 morphine and oxazepam in urine. 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 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. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Source page: https://510kreport.com/device/K140089
Methodology: https://510kreport.com/methodology