510(k) · Cleared
ClearedPsychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psychemedics Corporation · DJG Enzyme Immunoassay, Opiates
Cleared on Jul 27, 2021 as substantially equivalent to K111926 (Psychemedics Corp., 2012) and 1 other predicate after a 434-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 27, 2021
- Review
- 434 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000851 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000851 | Psychemedics Analysis of Morphine in Hair | Psychemedics Corp. | 2000 | — |
| −1 | K111926 | Psychemedics Opiates Eia | Psychemedics Corp. | 2012 | — |
| 0 (this device) | K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair… | Psychemedics Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K111926 | Psychemedics Opiates EiaSummary page 4…ychemedics Homogeneous Enzyme Immunoassay for Oxycodone in Hair Predicate Device: Psychemedics Microplate EIA for Opiates in Hair, k111926 and Psychemedics Microplate EIA for Oxycodone in Hair, k123799 Product Code: DJG Devi… | 2012 |
| * | K123799 | Psychemedics Microplate Eia for Oxycodone in HairSummary page 4…Predicate Device: Psychemedics Microplate EIA for Opiates in Hair, k111926 and Psychemedics Microplate EIA for Oxycodone in Hair, k123799 Product Code: DJG Device/Classification Name: 21 CFR 862.3650 Opiate Test System, Classific… | 2013 |
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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 Psychemedics homogeneous enzyme immunoassay (HEIA) for opiates in hair is an enzyme immunoassay for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng morphine/10 mg hair for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for…
Read the full statement (216 words)
The Psychemedics homogeneous enzyme immunoassay (HEIA) for opiates in hair is an enzyme immunoassay for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng morphine/10 mg hair for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for opiates in hair provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method.
The Psychemedics homogeneous enzyme immunoassay (HEIA) for oxycodone in hair is an enzyme immunoassay for the preliminary qualitative detection of oxycodone in human head and body hair using an oxycodone calibrator at 2 ng oxycodone/10 mg hair for the purpose of identifying opioid use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for oxycodone in hair provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method.
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/K201326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201326: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201326
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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