510(k) · Cleared
ClearedEmit II Opiates 300/2000 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 25, 1997 as substantially equivalent to K902577 (Syva Co., 1990) after a 55-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Jun 25, 1997
- Review
- 55 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902577 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902577 Emit (R) II Opiate AssaySyva Co. · 1990
- This deviceK971596 Emit II Opiates 300/2000 AssayBehring Diagnostics, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK013314 OpiatesAbbott Laboratories · 2002
- Descendant · cites it directly · 0 of its ownK984232 Modification of Emit D.a.U. Opiates AssaySyva Co. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902577 | Emit (R) II Opiate Assay | Syva Co. | 1990 | — |
| 0 (this device) | K971596 | Emit II Opiates 300/2000 Assay | Behring Diagnostics, Inc. | 1997 | — |
| +1 | K013314 | Opiates | Abbott Laboratories | 2002 | — |
| +1 | K984232 | Modification of Emit D.a.U. Opiates Assay | Syva Co. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K902577 | Emit (R) II Opiate AssaySummary page 1…with a 300 ng/mL or 2000 ng/mL cutoff. The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics. PERFORMANCE STUDIES Qualitatively, utilizi… | 1990 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K013314 (Abbott Laboratories, 2002) 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.
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 Emite IT Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is mtended for use.in the qualitative and semiquantitative analysis of opiates in human urine.
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/K971596 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971596: Emit II Opiates 300/2000 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971596
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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