510(k) · Cleared
ClearedQuest Diagnostics Haircheck-DT (Opiates)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jul 6, 2005 after a 278-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jul 6, 2005
- Review
- 278 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK042725 Quest Diagnostics Haircheck-DT (Opiates)Quest Diagnostics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK103161 Omega Laboratories Hair Drug Screening Assay for OpiatesOmega Laboratories, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK140671 Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone…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) | K042725 | Quest Diagnostics Haircheck-DT (Opiates) | Quest Diagnostics, Inc. | 2005 | — |
| +1 | K103161 | Omega Laboratories Hair Drug Screening Assay for Opiates | Omega Laboratories, Inc. | 2011 | — |
| +2 | K140671 | Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and… | 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K103161 | Omega Laboratories Hair Drug Screening Assay for Opiates | 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, K103161 (Omega Laboratories, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users. This test system has not been evaluated for use with other user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for…
Read the full statement (164 words)
The Quest Diagnostics Hair Check-DT (Opiates) is a test system that utilizes the IDS One-Step ELISA Opiates Kit for the qualitative detection of opiates at or above 500 pg/mg in head hair samples from chronic heroin users. This test system has not been evaluated for use with other user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for sale to anyone
The QUEST DIAGNOSTICS HairCheck-DT (Opiates) 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 510(k) statement.
https://510kreport.com/device/K042725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042725: Quest Diagnostics Haircheck-DT (Opiates).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042725
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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