510(k) · Cleared
ClearedCR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Feb 25, 2015 as substantially equivalent to K122904 (Guangzhou Wondfo Biotech Co., Ltd., 2012) after a 29-day review. Its family tree reaches back 1 generation to 2012. 1 later device descends from it.
- Decided
- Feb 25, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122904 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK122904 Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU…Guangzhou Wondfo Biotech Co., Ltd. · 2012
- This deviceK150179 CR3 Keyless Split Sample Cup Oxycodone - CannabinoidsGuangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122904 | Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU… | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| 0 (this device) | K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +1 | K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122904 | Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU…Summary page 4…FR, 862.3650 Opiate Test System Toxicology LDJ 21 CFR, 862.3870 Cannabinoid Test System Toxicology 5. Predicate Devices: K122904 Wondfo Multi-Drug Urine Test Cup 6. Intended Use: CR3 Keyless Split Sample Cup Oxycodone-Cannabinoi… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151478 | Wondfo CR3 Keyless Split Sample Cup | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids is a rapid test for the qualitative detection of Oxycodone and Cannabinoids in human urine at a cutoff concentration of 100 ng/mL and 50 ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use. The test may yield…
Read the full statement (177 words)
CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids is a rapid test for the qualitative detection of Oxycodone and Cannabinoids in human urine at a cutoff concentration of 100 ng/mL and 50 ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use.
The test may yield preliminary positive results even when the prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150179 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150179: CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150179
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026