510(k) · Cleared
Recalled · Class II · 2017Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Nov 22, 2006 as substantially equivalent to K031004 (Dade Behring, Inc., 2003) and 1 other predicate after a 124-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Nov 22, 2006
- Review
- 124 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993982 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK993982 Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULSyva Co. · 2000
- 1 generation backK031004 Syva Emit II Plus Amphetamines AssayDade Behring, Inc. · 2003
- This deviceK062077 Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK143500 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…Immunalysis Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993982 | Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL | Syva Co. | 2000 | — |
| −1 | K031004 | Syva Emit II Plus Amphetamines Assay | Dade Behring, Inc. | 2003 | — |
| 0 (this device) | K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| +1 | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine… | Immunalysis Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K031004 | Syva Emit II Plus Amphetamines AssaySummary page 3…ROS Chemistry Products to predicate DAT Performance Verifiers are substantially equivalent to the Syva® EMIT LI Plus devices: Amphetamines assay (K031004) and Bio-Rad Liquichecku" Urine Toxicology Controls (K022707) predicate devices which were cleared by the… | 2003 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 3…ially equivalent to the Syva® EMIT LI Plus devices: Amphetamines assay (K031004) and Bio-Rad Liquichecku" Urine Toxicology Controls (K022707) predicate devices which were cleared by the FDA for IVD use.… | 2002 |
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 |
|---|---|---|---|
| K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2017 | Class II | Z-0911-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0913-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0912-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0914-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0915-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143500 (Immunalysis Corporation, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031004.
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?
For in vitro diagnostic use only. VITROS Chemistry Products AMPH Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of amphetamines (AMPH) in human urine using a cutoff of either 500 or 1000 ng/mL. Measurements obtained with the VITROS AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The VITROS Chemistry Products AMPH assay is intended for use by professional…
Read the full statement (218 words)
For in vitro diagnostic use only. VITROS Chemistry Products AMPH Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of amphetamines (AMPH) in human urine using a cutoff of either 500 or 1000 ng/mL. Measurements obtained with the VITROS AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
The VITROS Chemistry Products AMPH assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. 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 evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062077: Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062077
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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