510(k) · Cleared
ClearedOne Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test Dipcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Innovation Biotech Co., Ltd. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jan 15, 2014 as substantially equivalent to K091588 (Ucp Biosciences, Inc., 2009) after a 271-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Jan 15, 2014
- Review
- 271 days
- Class
- Class II
- Product code
- DKZ
- 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 deviceK131110 One Step Single/Multi-Drug Test Cup; One Step Single…Co-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) | K131110 | One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test… | 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 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 |
|---|---|---|---|
| * | K091588 | Ucp Home Drug Screening TestsSummary page 2…Test Dipcard 05-I Co-Innovation Biotech Co.,Ltd. 4. The Predicate Devices K091588 UCP lFlomeT'M Drug Screening Trest Cards UJCP Homer 1M Drug Screening Test Cup 5. Device IDesc… | 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 DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 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 immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations: Test Calibrator Cut-off level Marijuana (THC) Delta-9-THC-COOH 50 ng/mL Cocaine (COC) Benzoylecgonine 300 ng/mL Amphetamine (AMP) D-Amphetamine 1000 ng/mL Methamphetamine (MET)…
Read the full statement (216 words)
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:
Test Calibrator Cut-off level
Marijuana (THC) Delta-9-THC-COOH 50 ng/mL
Cocaine (COC) Benzoylecgonine 300 ng/mL
Amphetamine (AMP) D-Amphetamine 1000 ng/mL
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 2000 (MOP) Morphine 2000 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.
These tests provide only a preliminary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained with the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipcard Insert, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. 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/K131110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131110: One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test Dipcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131110
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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