510(k) · Cleared
ClearedCR3 Keyless Split Sample Cup (Opi-Bzo)
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 Apr 8, 2014 as substantially equivalent to K130665 (Guangzhou Wondfo Biotech Co., Ltd., 2013) after an 84-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Apr 8, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020771 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- 2 generations backK112071 Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo…Guangzhou Wondfo Biotech Co., Ltd. · 2011
- 1 generation backK130665 Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd. · 2013
- This deviceK140089 CR3 Keyless Split Sample Cup (Opi-Bzo)Guangzhou Wondfo Biotech Co., Ltd. · 2014
- 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 |
|---|---|---|---|---|---|
| −3 | K020771 | Acon One Step Drug Screen Test Card | ACON Laboratories, Inc. | 2002 | — |
| −2 | K112071 | Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2011 | — |
| −1 | K130665 | Wondofo Multi-Drug Urine Test Cup / Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2013 | — |
| 0 (this device) | K140089 | CR3 Keyless Split Sample Cup (Opi-Bzo) | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +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 |
|---|---|---|---|
| * | K130665 | Wondofo Multi-Drug Urine Test Cup / PanelSummary page 1…icate Devices: Guangzhou Wondfo Biotech Co., Ltd. Wondfo Multi-Drug Urine Test Cup (Panel) (K130665) 6. Intended Use CR3 Keyless Split Sample Cup Morphine-Oxazepamn is a rapid test for the qualitative detection of Morphine… | 2013 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151478 (Guangzhou Wondfo Biotech Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K130665.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 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…
Read the full statement (157 words)
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.
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/K140089 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140089: CR3 Keyless Split Sample Cup (Opi-Bzo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140089
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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