510(k) · Cleared
ClearedPsychemedics Opiates Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psychemedics Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on May 1, 2012 as substantially equivalent to K000851 (Psychemedics Corp., 2000) after a 300-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- May 1, 2012
- Review
- 300 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000851 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000851 Psychemedics Analysis of Morphine in HairPsychemedics Corp. · 2000
- This deviceK111926 Psychemedics Opiates EiaPsychemedics Corp. · 2012
- Descendant · cites it directly · 0 of its ownK201326 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in…Psychemedics Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics…Psychemedics Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000851 | Psychemedics Analysis of Morphine in Hair | Psychemedics Corp. | 2000 | — |
| 0 (this device) | K111926 | Psychemedics Opiates Eia | Psychemedics Corp. | 2012 | — |
| +1 | K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair… | Psychemedics Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K000851 | Psychemedics Analysis of Morphine in HairSummary page 2…_________________ result is positive. _____________________ 10Ok K111926 K000851 Measurand Opiates Opiates Matrix Human head or body hair… | 2000 |
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 |
|---|---|---|---|
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics… | 2021 | 0 |
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.
- Of its descendants, K201326 (Psychemedics Corporation, 2021) has gone furthest, with 0 descendants 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. 2012, 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 Psychemnedics Microplate ETA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemnedics use only and is not intended for sale to anyone. The Psychemedics Microplate ELA opiate assay provides only a preliminary…
Read the full statement (130 words)
The Psychemnedics Microplate ETA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemnedics use only and is not intended for sale to anyone.
The Psychemedics Microplate ELA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111926: Psychemedics Opiates Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111926
Report an extraction error
Are you the manufacturer?
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