510(k) · Cleared
ClearedAmphetamines II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Feb 3, 2010 as substantially equivalent to K983699 (Roche Diagnostic Systems, Inc., 1998) after a 412-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Feb 3, 2010
- Review
- 412 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933052 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- 1 generation backK983699 Modification to Abuscreen Online for AmphetaminesRoche Diagnostic Systems, Inc. · 1998
- This deviceK083764 Amphetamines IIRoche Diagnostics Corp. · 2010
- Descendant · cites it directly · 0 of its ownK093664 Amphetamines II AssayRoche Diagnostics Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093664Amphetamines II AssayRoche Diagnostics Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| −1 | K983699 | Modification to Abuscreen Online for Amphetamines | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K083764 | Amphetamines II | Roche Diagnostics Corp. | 2010 | — |
| +1 | K093664 | Amphetamines II Assay | Roche Diagnostics Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K983699 | Modification to Abuscreen Online for AmphetaminesSummary page 3…ed for similar use. Most notably, we claim substantial equivalence to the currently marketed Abuscreen ONLINE Amphetamines assay (K983699). The ONLINE Amphetamines LI assay contains an in vitro diagnostic reagent system intend… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093664 | Amphetamines II Assay | 2010 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093664 (Roche Diagnostics Corp., 2010) has gone furthest, with 0 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. 2010, 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?
Amphetamines 1I (AMP1I) is an in vitro diagnostic test for the qualitative and semniquantitative detection of amphetamines and methamphetarnines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1 000 ng/mnL when calibrated with d-inethamphetarnine. Semniquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Serniquarititative assays…
Read the full statement (141 words)
Amphetamines 1I (AMP1I) is an in vitro diagnostic test for the qualitative and semniquantitative detection of amphetamines and methamphetarnines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1 000 ng/mnL when calibrated with d-inethamphetarnine. Semniquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Serniquarititative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromnatography/mass spectrometry (GC/MS).
Amphetamines II provides only a preliminary analytical test result. A more specific alternate chemical method must he used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.) Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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/K083764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083764: Amphetamines II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083764
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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