510(k) · Cleared
ClearedQuest Diagnostics HairCheck-DT (Cocaine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Diagnostics Incorporated · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Nov 18, 2016 as substantially equivalent to K023626 (Quest Diagnostics, Inc., 2003) after a 469-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Nov 18, 2016
- Review
- 469 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023626 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023626 Aml Haircheck-DT (Cocaine)Quest Diagnostics, Inc. · 2003
- This deviceK152232 Quest Diagnostics HairCheck-DT (Cocaine)Quest Diagnostics Incorporated · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023626 | Aml Haircheck-DT (Cocaine) | Quest Diagnostics, Inc. | 2003 | — |
| 0 (this device) | K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | Quest Diagnostics Incorporated | 2016 | — |
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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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 |
|---|---|---|---|
| * | K023626 | Aml Haircheck-DT (Cocaine)Summary page 4…ader capable of measuring at 450 and 620 nm. Instrument Requirements Specimen Head Hair Collection Predicate Device Quest Diagnostics HairCheck-DT (Cocaine) (K023626) Reference Presumptive positives are confirmed with Quantitative GC-MS Method Device The Quest Diagnostics H… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K023626.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house…
Read the full statement (167 words)
The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA)
for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites
for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from
locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is
not intended for sale to anyone.
The Hair Check-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be
chronic drug abusers, and individuals proclaiming to be drug-free.
The Quest Diagnostics Hair Check-DT (Cocaine) test system provides only a preliminary analytical test result. To
confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography -
mass spectrometry (GC/MS) must be used. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152232: Quest Diagnostics HairCheck-DT (Cocaine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152232
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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