510(k) · Cleared
ClearedHomecheck Multiple Drug Cup 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 Mar 28, 2008 as substantially equivalent to K052882 (Tianjin New Bay Bioresearch Co., Ltd., 2006) after a 303-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Mar 28, 2008
- Review
- 303 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K004034 (2001). 3 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 deviceK071489 Homecheck Multiple Drug Cup TestTianjin New Bay Bioresearch Co., Ltd. · 2008
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) | K071489 | Homecheck Multiple Drug Cup Test | Tianjin New Bay Bioresearch Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K052882 | Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceSummary page 2…and Multiple (X) Abuse Drug Screen Test Cup Device are substantially equivalent to New Bay Forsure Multiple Drug Screen Test Device ( Professional Use ), cleared by FDA( K052882) and GC/MS for its stated intended use. Device Description: New Bay HomeCheck Rapid Single and Multiple(X) Abuse Drug Screen Te… | 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 7 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K052882.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine.
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. HPLC is preferred confirmatory method for Tricyclic Antidepressant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071489 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071489: Homecheck Multiple Drug Cup Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071489
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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