510(k) · Cleared
ClearedQuikscreen Multi (Mdma and Opi) Otc Drug Cup Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin New Bay Bioresearch Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Sep 26, 2013 as substantially equivalent to K121166 (Guangzhou Wondfo Biotech Co., Ltd., 2012) after a 234-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Sep 26, 2013
- Review
- 234 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K121166 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backK121166 Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test PanelGuangzhou Wondfo Biotech Co., Ltd. · 2012
- This deviceK130275 Quikscreen Multi (Mdma and Opi) Otc Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K121166 | Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | 2012 | — |
| 0 (this device) | K130275 | Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test | Tianjin New Bay Bioresearch Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K121166 | Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test PanelSummary page 2…creenT M Multi (MDMA and OPI) Drug Cup Test Device is substantially equivalent to predicate device (Guanzhou Wondfo Biotech Co Multi-Drug Urine Test Cup) cleared by FDA (K1 21 166) for its stated intended use. Product Desction: Quik creeng Muti (MDMA and OPI) Drug Cup Test Device is a convenient specimen co… | 2012 |
| † | K071489 | Homecheck Multiple Drug Cup Test | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The QuikScreen T M Multi (MDMA and OPI) Drug Cup Test consists of competitive binding, lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 nglml and OPI at or above the cutoff level of 300 nglml in human urine. The device is intended for prescription use and Over-The-Counter settings. Test Calibrator Cutof Opiate…
Read the full statement (148 words)
The QuikScreen T M Multi (MDMA and OPI) Drug Cup Test consists of competitive binding, lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 nglml and OPI at or above the cutoff level of 300 nglml in human urine. The device is intended for prescription use and Over-The-Counter settings.
Test Calibrator Cutof
Opiate Morphine 300 nglml
MOMA (+/-)-3,4Mcthylene- 500 ng/ml
dioxymethamphetamine
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GCIMS or LC/MS is the preferred confirmatory method. Clinical and professional judgment should be exercised with any drug of abuse test result, particularly when preliminary results are used. The assay does not distinguish whether OPI or MDMA is being taken therapeutically or abused.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130275: Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130275
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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