# K151478: Wondfo CR3 Keyless Split Sample Cup

- Pathway: 510(k) (Special)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Jul 1, 2015 after 29 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: 9 generations back to K945610 (1995). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141532: CR3 Keyless Split Sample Cup Amphetamine-Cocaine, Guangzhou Wondfo Biotech Co., Ltd. (2014) Summary page 7.
- K140089: CR3 Keyless Split Sample Cup (Opi-Bzo), Guangzhou Wondfo Biotech Co., Ltd. (2014) Summary page 7.
- K142044: CR3 Keyless Split Sample Cup Phencyclidien - Methylenedioxymethamphetamine, Guangzhou Wondfo Biotech Co., Ltd. (2014) Summary page 7.
- K142609: CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine, Guangzhou Wondfo Biotech Co., Ltd. (2014) Summary page 7.
- K143535: CR3 Keyless Split Sample Cup Secobarbital- Methadone, Guangzhou Wondfo Biotech Co., Ltd. (2015) Summary page 7.
- K150179: CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids, Guangzhou Wondfo Biotech Co., Ltd. (2015) Summary page 7.
- K150602: CR3 Keyless Split Sample Cup Morphine - Methamphetamine, Guangzhou Wondfo Biotech Co., Ltd. (2015) Summary page 7.

## Indications for use
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine 1000 ng/mL Secobarbital 300 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Cannabinoids 50 ng/mL Methamphetamine 1000 ng/mL Methylenedioxymethamphetamine 500 ng/mL Morphine 300 ng/mL or 2000 ng/mL Phencyclidine 25 ng/mL Oxycodone 100 ng/mL Buprenorphine 10 ng/mL Methadone 300/ng/mL Notriptyline 1000ng/mL Configuration of the Wondfo CR3 Keyless Split Sample Cup can consist of any combination of the above listed drug analytes. 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. The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic 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.

Source page: https://510kreport.com/device/K151478
Methodology: https://510kreport.com/methodology