510(k) · Cleared
ClearedModification to Abuscreen Online for Amphetamines
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 Dec 11, 1998 as substantially equivalent to K933052 (Roche Diagnostic Systems, Inc., 1993) after a 51-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933052 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- This deviceK983699 Modification to Abuscreen Online for AmphetaminesRoche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK083764 Amphetamines IIRoche Diagnostics Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK093664 Amphetamines II AssayRoche Diagnostics Corp. · 2010
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 | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| 0 (this device) | K983699 | Modification to Abuscreen Online for Amphetamines | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K083764 | Amphetamines II | Roche Diagnostics Corp. | 2010 | — |
| +2 | K093664 | Amphetamines II Assay | Roche Diagnostics Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K933052 | Abuscreen Online (R) for Amphetamines, ModifiedSummary page 2…gnostic Systems, Inc. claims equivalence. Table 2 Product Name Predicate Product 510(k) Number and Date Name Predicate Cleared Abuscreen ONLINE for Abuscreen ONLINE for K933052 9/15/93 Amphetamines Amphetamines 028 Roche Diagnostic Syvstems. Inc. Abuscreen ONLINE® Amphetamines Somerviil… | 1993 |
| † | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083764 | Amphetamines II | 2010 | 1 |
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?
Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the
qualitative and semiquantitative detection of amphetamine and methamphetamine
and their metabolites in human urine on automated clinical chemistry analyzers at a
cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit
laboratories to assess assay performance as part of a quality control program.
Measurements obtained by this device are used in the diagnosis of amphetamine
use or abuse.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983699: Modification to Abuscreen Online for Amphetamines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983699
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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