510(k) · Cleared
ClearedForsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device
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 Feb 15, 2006 as substantially equivalent to K004034 (Branan Medical Corp., 2001) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Feb 15, 2006
- Review
- 126 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K004034 (2001). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK004034 Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and…Branan Medical Corp. · 2001
- This deviceK052882 Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceTianjin New Bay Bioresearch Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK071489 Homecheck Multiple Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK061617 Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K004034 | Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12 | Branan Medical Corp. | 2001 | — |
| 0 (this device) | K052882 | Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device | Tianjin New Bay Bioresearch Co., Ltd. | 2006 | — |
| +1 | K071489 | Homecheck Multiple Drug Cup Test | Tianjin New Bay Bioresearch Co., Ltd. | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K004034 | Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12Summary page 2…ingle and Multiple (X) Abuse Drug Screen Test Cup Device is substantially equivalent to Monitect Multiple Drug Screen Test of Branan Medical Corporation, cleared by FDA( K004034), or Alfa Scientific Design Instant-View Propoxyphene (PPX) urine test cleared by FDA ( K022915 )and GC/MS for its stated intende… | 2001 |
| * | K022915 | Instant-View Propoxyphene (PPX) Urine TestSummary page 2…Multiple Drug Screen Test of Branan Medical Corporation, cleared by FDA( K004034), or Alfa Scientific Design Instant-View Propoxyphene (PPX) urine test cleared by FDA ( K022915 )and GC/MS for its stated intended use. Device Description: New Bay Forsure Rapid One Step Single and Multiple(X) Abuse Drug Sc… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device for Detection of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Cannabinoid, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates, Propoxyphene and their metabolites in human urine at the following concentrations:
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /Mass spectrometry (GC/MS) is the preferred confirmatory method. The testing and results are intended to be used by medical professional and clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052882 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052882: Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052882
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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