510(k) · Cleared
Recalled · Class III · 2018Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-AM / Ectasy C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Mar 18, 2011 as substantially equivalent to K001178 (Microgenics Corp., 2000) and 1 other predicate after a 175-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 18, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- DJG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010496 (2001). 6 ancestors in all, the oldest K983159 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK010496 Cedia Dau Amphetamines/Ecstasy AssayMicrogenics Corp. · 2001
- 2 generations backK012110 Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001
- 1 generation backK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
- This deviceK102779 Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy…Siemens Healthcare Diagnostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK150275 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine…Immunalysis Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010496 | Cedia Dau Amphetamines/Ecstasy Assay | Microgenics Corp. | 2001 | — |
| −2 | K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corp. | 2001 | — |
| −1 | K043028 | Emit II Plus Ecstasy Assay | Dade Behring, Inc. | 2005 | — |
| 0 (this device) | K102779 | Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/… | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
| +1 | K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis… | Immunalysis Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K001178 | Cedia Dau 6-Acetylmorphine AssaySummary page 4…Proposed Device Acetylmorphine Assay Feature Emit® HI Plus 6-Acetylmorphine Assay (k001178) The Emit® 11 Plus 6-Acetylmorphine Assay The CEDIA® Heroin Metabolite… | 2000 |
| * | K043028 | Emit II Plus Ecstasy AssaySummary page 2…Calibrator The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are substantially equivalent to the Emit® 11 Plus Ecstasy Calibrators / Controls cleared under k043028. Control The Emit®W 11 Plus 6-AM / Ecstasy Calibrators / Controls are substantially equivalent to the Emit® 11 Plus E… | 2005 |
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 |
|---|---|---|---|
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2018 | Class III | Z-1800-2018 | Under Investigation by firm | Incorrect calibrator level listed in qualitative calibration steps |
| Mar 12, 2018 | Class III | Z-1799-2018 | Under Investigation by firm | Incorrect calibrator level listed in qualitative calibration steps |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150275 (Immunalysis Corporation, 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K001178.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Emit® 11 Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® 11 Plus assays are designed for use with a number of chemistry analyzers. Semiquantitative test results may be used to assess assay performance as part of a quality control program and to…
Read the full statement (185 words)
The Emit® 11 Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® 11 Plus assays are designed for use with a number of chemistry analyzers.
Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS.
The Emit® 11 Plus 6-Acetylmorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. 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 used.
Calibrators are used in the calibration of the Emit® 11 Plus 6-Acetylmorphine and Emit® 11 Plus Ecstasy Assays.
Controls may be used as quality control materials based on the specific Emit® 11 Plus 6-Acetylmorphine and Emit® 11 Plus Ecstasy Assay cutoffs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102779: Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-AM / Ectasy C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102779
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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