510(k) · Cleared
ClearedAbuscreen Online (R) for Amphetamines, Modified
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Sep 15, 1993 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 25 later devices descend from it.
- Decided
- Sep 15, 1993
- Review
- 112 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 3 citing it directly.
- This deviceK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- Descendant · cites it directly · 14 of its ownK992918 STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK993208 STC Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 6 of its ownK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- Descendant · 3 generations on · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK062242 Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay…Lin-Zhi International, Inc. · 2006
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K992918STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 2000 · cites it directly14descendants
- K993208STC Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc. · 2000 · cites it directly7descendants
- K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012 · 2 generations on6descendants
- K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · 3 generations on3descendants
- K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc. · 2006 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| +1 | K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I | OraSure Technologies, Inc. | 2000 | — |
| +1 | K993208 | STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I | OraSure Technologies, Inc. | 2000 | 1 |
| +2 | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| +3 | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +2 | K062242 | Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and… | Lin-Zhi International, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (25)
See all 253 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, K992918 (OraSure Technologies, Inc., 2000) has gone furthest, with 14 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/K933052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933052: Abuscreen Online (R) for Amphetamines, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933052
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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