510(k) · Cleared
Cleared6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jul 6, 2010 as substantially equivalent to K001178 (Microgenics Corp., 2000) after a 68-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 6, 2010
- Review
- 68 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001178 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- This deviceK101195 6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine…Lin-Zhi International, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK141205 Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid…Lin-Zhi International, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K141205Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-Acetylmorphine…Lin-Zhi International, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| 0 (this device) | K101195 | 6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine Calibrators and… | Lin-Zhi International, Inc. | 2010 | — |
| +1 | K141205 | Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid… | Lin-Zhi International, Inc. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K001178 | Cedia Dau 6-Acetylmorphine AssaySummary page 2…Calibrators andCnrlfo CEDA DAU6~Actylmorphifle Microeflic LZI 6-mso Hitachi 717 Systems (K(001178) manufactured byMcoPisCrp.icthe itsprdctinemso… | 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 |
|---|---|---|---|
| K141205 | Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-Acetylmorphine… | 2015 | 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?
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in human urine, at a cutoff value of 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the 6-Acetylmorphine Enzyme Immunoassay. The…
Read the full statement (147 words)
The 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in human urine, at a cutoff value of 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the 6-Acetylmorphine Enzyme Immunoassay.
The 6-Acetylmorphine Drugs of Abuse (DAUI) Controls are for use as assayed quality control materials to monitor the precision of the 6-Acetylmorphine Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specijfic 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) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
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/K101195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101195: 6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101195
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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