510(k) · Cleared
ClearedOne Step Single/Multi-Drug Test Cup/Dipcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Innovation Biotech Co., Ltd. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Jun 16, 2014 as substantially equivalent to K091588 (Ucp Biosciences, Inc., 2009) after a 139-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Jun 16, 2014
- Review
- 139 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091588 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK091588 Ucp Home Drug Screening TestsUcp Biosciences, Inc. · 2009
- This deviceK140215 One Step Single/Multi-Drug Test Cup/DipcardCo-Innovation Biotech Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091588 | Ucp Home Drug Screening Tests | Ucp Biosciences, Inc. | 2009 | — |
| 0 (this device) | K140215 | One Step Single/Multi-Drug Test Cup/Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
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 DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091588 | Ucp Home Drug Screening TestsSummary page 2…-drug Test flipcard 05-1 Co-Innovation Biotech Co.,Ltd. 4. The Predicate Devices K091588 UCP HomeTm Drug Screening Test Cards UCP Home1 mDrug Screening Test Cup 5. Device Description On… | 2009 |
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.
- 3 other devices also cite its predicate K091588.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test | Calibrator | Cut-off level Barbiturates (BAR) | Secobarbital | 300 ng/mL Benzodiazepines (BZO) | Oxazepam | 300 ng/mL Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine |…
Read the full statement (175 words)
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
Test | Calibrator | Cut-off level
Barbiturates (BAR) | Secobarbital | 300 ng/mL
Benzodiazepines (BZO) | Oxazepam | 300 ng/mL
Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL
Methadone (MTD) | Methadone | 300 ng/mL
Oxycodone (OXY) | Oxycodone | 100 ng/mL
Phencyclidine (PCP) | Phencyclidine | 25 ng/mL
The tests contain two formats: 1) Test Cup, 2) Test Dipcard. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140215: One Step Single/Multi-Drug Test Cup/Dipcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140215
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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