510(k) · Cleared
ClearedQuest Diagnostics Haircheck-DT (Amphetamines)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Diagnostics, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Nov 22, 2005 after a 201-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Nov 22, 2005
- Review
- 201 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK051161 Quest Diagnostics Haircheck-DT (Amphetamines)Quest Diagnostics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK101973 Omega Laboratories Hair Drug Screening Assay for Methamphetamine and…Omega Laboratories, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK142855 Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth)…Omega Laboratories, Inc. · 2015
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 |
|---|---|---|---|---|---|
| 0 (this device) | K051161 | Quest Diagnostics Haircheck-DT (Amphetamines) | Quest Diagnostics, Inc. | 2005 | — |
| +1 | K101973 | Omega Laboratories Hair Drug Screening Assay for Methamphetamine and… | Omega Laboratories, Inc. | 2011 | — |
| +2 | K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3… | Omega Laboratories, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K101973 | Omega Laboratories Hair Drug Screening Assay for Methamphetamine and… | 2011 | 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?
- Of its descendants, K101973 (Omega Laboratories, Inc., 2011) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) is a test system that utilizes the IDS One-Step ELISA MDMA/Methamphetamine Kit for the qualitative detection of amphetamines at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic methamphetamine use and use of MDMA. This test system has not been evaluated for use with other populations or with hair specimens other than head. It is an in vitro diagnostic device intended…
Read the full statement (166 words)
QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) is a test system that utilizes the IDS One-Step ELISA MDMA/Methamphetamine Kit for the qualitative detection of amphetamines at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic methamphetamine use and use of MDMA. This test system has not been evaluated for use with other populations or with hair specimens other than head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and not intended for sale to anyone.
The QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051161: Quest Diagnostics Haircheck-DT (Amphetamines).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051161
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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