510(k) · Cleared
ClearedMonitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Branan Medical Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Mar 8, 2001 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 8, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK004034 Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and…Branan Medical Corp. · 2001
- Descendant · cites it directly · 2 of its ownK052882 Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceTianjin New Bay Bioresearch Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK071489 Homecheck Multiple Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK061617 Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK052520 Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device…Tianjin New Bay Bioresearch Co., Ltd. · 2006
Most influential descendants
Showing 4 of 4 · See all- K052882Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceTianjin New Bay Bioresearch Co., Ltd. · 2006 · cites it directly2descendants
- K071489Homecheck Multiple Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2008 · 2 generations on0descendants
- K061617Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd. · 2006 · 2 generations on0descendants
- K052520Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device for Amphetamine…Tianjin New Bay Bioresearch Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K071489 | Homecheck Multiple Drug Cup Test | Tianjin New Bay Bioresearch Co., Ltd. | 2008 | — |
| +2 | K061617 | Forsure One Step Dip & Read (X) Drug Screen Test | Tianjin New Bay Bioresearch Co., Ltd. | 2006 | — |
| +1 | K052520 | Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device for… | Tianjin New Bay Bioresearch Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K052882 (Tianjin New Bay Bioresearch Co., Ltd., 2006) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K004034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K004034: Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K004034
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026