510(k) · Cleared
ClearedForsure One Step Dip & Read (X) Drug Screen Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin New Bay Bioresearch Co., Ltd. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Nov 22, 2006 as substantially equivalent to K050540 (Ucp Biosciences, Inc., 2005) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 22, 2006
- Review
- 166 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K004034 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK004034 Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and…Branan Medical Corp. · 2001
- 1 generation backK052882 Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceTianjin New Bay Bioresearch Co., Ltd. · 2006
- This deviceK061617 Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K004034 | Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12 | Branan Medical Corp. | 2001 | — |
| −1 | K052882 | Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device | Tianjin New Bay Bioresearch Co., Ltd. | 2006 | — |
| 0 (this device) | K061617 | Forsure One Step Dip & Read (X) Drug Screen Test | Tianjin New Bay Bioresearch Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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 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? (2)
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 |
|---|---|---|---|
| * | K050540 | Ucp Rapid Drug Screening TestsSummary page 2…II Predicate Devices: Forsure One Step Dip & Read Drug Screen Test Device is substantially equivalent to UCP Bioscience Rapid Drug Screening Test Strips cleared by FDA (K050540), or TNB ForsUre One Step Drug Screen Test Cup Device cleared by FDA (K052882) and GC/MS for its stated intended use. Device Des… | 2005 |
| * | K052882 | Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceSummary page 2…substantially equivalent to UCP Bioscience Rapid Drug Screening Test Strips cleared by FDA (K050540), or TNB ForsUre One Step Drug Screen Test Cup Device cleared by FDA (K052882) and GC/MS for its stated intended use. Device Description: Forsure One Step Dip & Read Drug Screen Test consists of a or Multi… | 2006 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff…
Read the full statement (166 words)
Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels:
Test Calibrator Cutoff
Amphetamine D-Amphetamine 1000 ng/ml
Methamphetamine D-Methamphetamine 1000 ng/ml
Benzodiazepine Oxazepam 300 ng/ml
Barbiturate Secobarbital 300 ng/ml
Cocaine Benzoylecgonine 300 ng/ml
Cannabinoids 1 1-nor-A9-THC-9 COOH 50 ng/ml
Opiates Morphine 2000 ng/ml
Phencyclidine Phencyclidine 25 ng/ml
Methadone Methadone 300 ng/ml
Oxycodone Oxycodone 100 ng/ml
Tricyclic Antidepressant Nortriptyline 1000 ng/ml
Propoxyphene Propoxyphene 300 ng/ml
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061617: Forsure One Step Dip & Read (X) Drug Screen Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061617
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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