510(k) · Cleared
Recalled · Class II · 2019Synchron Systems Opiate Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Apr 29, 2003 as substantially equivalent to K944606 (Beckman-Diagnostic Systems Group, 1994) after a 29-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Apr 29, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- DJG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944606 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944606 CX Opiate Reagent for Synchron CX SystemsBeckman-Diagnostic Systems Group · 1994
- This deviceK031002 Synchron Systems Opiate ReagentBeckman Coulter, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944606 | CX Opiate Reagent for Synchron CX Systems | Beckman-Diagnostic Systems Group | 1994 | — |
| 0 (this device) | K031002 | Synchron Systems Opiate Reagent | Beckman Coulter, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K944606 | CX Opiate Reagent for Synchron CX SystemsSummary page 1…N Systems Opiate Reagent claims substantial equivalence to the SYNCHRON Systems Opiate Reagent currently in commercial distribution. (FDA 51O(k) Number K944606) 5.0 Device Description The SYNCHRON Systems Opiate (OP) reagent is designed for optimal performance… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2019 | Class II | Z-1752-2020 | Material/Component Contamination | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON@System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems. The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another…
Read the full statement (117 words)
Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON@System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.
The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031002: Synchron Systems Opiate Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031002
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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